Hip & Knee Surgery - Orthoworld

FROM THE EDITORDear Doctor,Through your continual feedback and in response to the rapidlychangingdynamics you face as surgeons, this 28th issue ofORTHOPAEDIC PRODUCT NEWS will be the last.In January 2010, we will launch a new publication entitledORTHOPRENEUR. This new publication will have singular depthand focus on managing the risks which increasingly challenge you asorthopaedic surgeons as you arrange to secure a predictable future inthe specialty. Hence the name, ORTHOPRENEUR.We have assembled an editorial panel of accomplished surgeonentrepreneurs, who will guide the content of the publication in order to:• Identify opportunities for orthopaedic surgeons to respond most optimally to changing regulations andincreased oversight.• Provide instruction in entrepreneurship, in order to allow surgeons to participate meaningfully and ethicallyin the commercialization process of new clinical therapies.• Continue to document the value of orthopaedic care to patients and society as a whole, as a way of ensuringadequate portions of the future healthcare pie.• Empower surgeons and their patients in their quest to remain the dominant voices in the orthopaedictreatment decision.• Provide access to experts in the areas of wealth preservation and management, practice enhancement, strategiesfor securing research funding, and business and legal assistance, to help you develop the new skillsneeded to thrive in the future.• Identify new and emerging technologies and treatments, in order for you to remain on the cutting edge inbuilding efficient and effective enterprises.Since many of you were educated in a time when the study of medicine was your sole academic focus,ORTHOPRENEUR is aimed at filling the education gap in areas increasingly being required of you in additionto your surgical skills.In short, ORTHOPRENEUR will be singularly dedicated to providing you the tools you need to enhance yourperformance, both personally and professionally. That is our promise to you.John A. EngelhardtEditor in Chief4 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

GUEST EDITORIALFinancing Healthcare Reform:A Novel and Workable ApproachAuthor: E. Marlowe Goble, M.D.Today, healthcare in the U.S. consumes 13 percent of our GrossNational Product (GNP). With healthcare costs projected toincrease 20 percent faster than the rate of inflation, by the year2020, more than 20 percent of our GNP will be spent in the healthcarearena.Future healthcare costs may be underestimated. Because ofexcellence in U.S. healthcare, 60 million soon-to-be-retired BabyBoomers will live beyond 80 years of age. Survival into this eighthdecade of life will pressure our healthcare system to continuallyimprove quality of life. Longer life, without maintenance of healthand vigor, will be unacceptable.I believe that the near-riotous reaction to President Obama’seffort to change the fixed direction of Healthcare (and the effortsof the six presidents prior) holds this fear in the balance…fear of alonger life without the American promise of a steady improvementin the ability of aging people to pursue happiness. Thepromise of longevity, without the increasing ability to care for itshealth challenges, becomes a prison.There exist four reasons why U.S. healthcare is great, and whyits future is so full of promise:1. Competitive Admission and TrainingHealthcare workers enjoy respect from the general populationfor their sacrifice. Healthcare workers literally give up theiryouth to be trained for this responsibility. Training exceedseducation, in that a trained healthcare professional performs atthe highest and most responsible level.2. Tort ReformIn the U.S., only a 20-year trained healthcare professional cansuccessfully perform under the confrontational legal examinationof our tort system. Medical doctors take responsibility forhuman care and measure outcomes objectively. The U.S. tortsystem will eliminate and embarrass any pretender.3. Medical InnovationNew procedures, devices, materials and understanding continueto improve healthcare. Innova-tion also rewards the inventorwith peer approval and financial gain. The incentives forhigh level research and development are correctly in place. U.S.citizens rely on a steady pace of improvement in healthcare toventure out into the risks of industry, sports, entertainment,military service, recreation, procreation and advancing age.4. Intolerance for Breeches of Human RightsAmerican ethics are based on egalitarian principles. Politically,our national laws protect life, liberty and the pursuit of happiness.Religion and good sense insist on value and worth of thesoul. Therefore, care of each other’s health has become a normin this century.No sensible person or agency disagrees that we must find away to decrease the cost of healthcare. This sensibility also insiststhat the greatness of U.S. Health Care must not change.I believe there is a way to afford our present level of U.S.healthcare without changing what makes it great. The answer is toincrease our medical “Resources.” The Resource available to affectboth the quality and cost of healthcare is the utilization of retiringhealthcare workers.An Historical PerspectiveIn the ancient republic of Rome, in the days of Cicero and JuliusCaesar, a shortage of grain would periodically paralyze the government,causing prices to skyrocket, resulting in discontent andthreatening political chaos. Since the Senate could do little tochange the weather patterns of southern Italy, increased local productionwas not an answer. But a resource of grain had to befound or financial and political instability would result.Egypt was conquered for its grain, not its Queen.Thus, the resources of increased employment (soldiers) andincreased grain saved the economy and the republic.The acquisition of new resources is usually the reason for foreignimperialism. The resources of oil and natural gas eliminatethe need for state income tax in Alaska and Wyoming. Theresource of nanocomputer technology and information has proceededto increase worker productivity.continued on page 76 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

GUEST EDITORIALcontinued from page 7patient to the orthopaedic surgeon working his one-day-per-weekshift. This surgeon would determine the care needed and schedulethe patient for surgery on Monday, one month later.A panel-approved orthopaedic surgeon who was scheduled towork on that Monday would perform the surgery. Different surgeons,depending on which one had been assigned that day ofwork, would perform follow-up.All Medicare-aged healthcare professionals (not only doctors)would fill these respective roles, one day per week.Pay to Medicare-aged professionals for their contributionswould be “in kind.” The Medicare-aged professional and hisMedicare-aged family would receive free medical care.Medicare patients, not having medical related skills, would utilizeMedicare funds the same way theypresently do. However, the demand forincreasing Medicare funds should be cutin half because all Medicare-age healthcareprofessionals, including retiredadministrators, janitorial service workersand volunteers, would not extractsalaries or benefits. For example, a typicalcommunity hospital’s staff wouldconsist of 30 percent Medicare-agedpeople servicing the healthcare needs ofSeniors. Medicare would pay nothingfor their service!On a Personal NoteThe Medicare-aged professional proposed is not a mere idea. Itis a reality.I am an orthopaedic surgeon, age 63, partially retired. Two daysper month I operate at Star Valley Hospital in Wyoming. I do onlywhat I do best. Patients there know me and trust me. If I attendtheir surgery, even though another surgeon does the work up andfollow up, they do not object. Malpractice expense is minimalbecause I am not the primary surgeon. I have no need for a clinicbecause I do no work up or follow up, except as requested by theprimary surgeon.I enjoy my limited work schedule. I am wanted and needed inthis small community. Because I participate in only my specialty,these patients have no need to travel for their care. The hospitaladministrator is very forward thinking and because of his foresight,patients have increasing confidence in their hospital. Thehospital is now expanding its facility.“Healthcare professionalsare dissatisfied with themanaged care approachto medical care. They willleave this fast changingoccupation as soon asthey can afford to.”As more and more women enter the practice of medicine,employment obligations to healthcare companies will become thenorm. Physicians, for several reasons, will abdicate traditionalhealthcare leadership responsibilities. Future physicians will filltechnical roles in this rapidly-evolving medical landscape, muchlike an engineer working for a large construction company.Malpractice attorneys will continue to police the “standard ofcare” model required of healthcare. However, because the healthcareof the Medicare-aged patient is administered by multiplecaregivers, tort remuneration would be the responsibility of theoversight panel, not a single individual. This is the same panelthat certifies the competency of its healthcare workers.These changes in the physician’s role will be difficult forMedicare patients to adapt to, but Medicare-aged professionalsmay offer a welcomed safe haven for this attention-spoiled generationof Baby Boomers. Summarily,Medicare patients will accept one-dayper-weekpeer medical care more readilythan a new generation more comfortablewith the impersonal efficienciesof modern integrated healthcare.For the Baby Boomer, retirement in2010 will be different than it was in1970. Baby Boomers will live in retirementas long as they worked in industry.Could it be possible that one-dayper-weekemployment could give balanceand additional meaning toadvancing age? And could it be possiblethat Medicare-aged professionalswould offer timely, empathetic medicalcare to Medicare patients – the kind we all dream aboutreceiving from our healthcare professionals – but in this instance,the care comes from their peers?Providing a New ResourceFuture direct Medicare cost can be significantly decreased (andcontrolled) by “in kind” utilization of retiring healthcare personnel.Seniors will not disapprove of this familiar medical care provision.Seniors will embrace it.Medicare-aged professionals are the Resource available to helpthe Federal Government ensure that changes in healthcare do not1) discourage top competitive medical school application, 2)undermine tort quality assurance, 3) eliminate incentives for innovationand 4) ignore human rights.The FutureToday, medical school enrollment is 55 percent female. Recenthistory documents women seeking less than full time medicalpositions shortly after completing training. Responsibilities relatingto child bearing and rearing conflict with the traditional centralpriority of medicine dominating a physician’s life.For the past ten years, increasing numbers of physicians havebeen abandoning independent practice, opting instead foremployment by the managed care industry, which ensures accessto patients and a predictable work schedule.Dr. Goble is a renowned surgeon, prolific researcher and inventor, as wellas a successful serial entrepreneur. He holds 72 patents, and has beenresponsible for many of the technologies considered the vanguard ofmodern standards of care for knee surgery. In 1994 he foundedMedicineLodge, Inc. as a vehicle for development and commercializationof his inventions. The company went on to become one of the mostsuccessful technology development firms in the orthopaedic space. Hecan be reached at em-goble@mtwest.net.8 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

THE TOP LINEcontinued from page 10It is obvious to me that the copious rule changes (or moreaccurately put, the more stringent enforcement of the rules), has beenmore than just an annoyance to many physicians. Many consultingsurgeons feel devalued. And, as I fearfully predicted several yearsago in this very column, that mindset makes them unwilling toparticipate in the design and development of new products andsurgical techniques unless their work is compensated commensuratelywith the work that they do in their medical practices, which isusually not possible. For what it is worth, I agree that the currentclimate does not allow for appropriate compensation of certainphysicians in certain circumstances. 2 Any change in that regard,however, must be systemic, not made on a case by case basis. And myrecommendation to any physician who recognizes himself in the“who doesn’t get it” category is that he should be mindful of the factthat until the compliance culture itself begins to allow for some of thevariations that I think should exist, the bright line rule is the best rule.So in this one instance, let your students and other surgeonyoungsters be your mentors. Follow their lead, accept the rules asthey have (as if you have known nothing else), and exercise yourfirst amendment right to free speech in an effort to make the rulesa better fit for all who practice orthopaedic medicine. I shall joinyou in the fight.The Law Offices of Teresa Ford, PC (www.tfordlaw.com), located inHouston, Texas and Kirkland, Washington, specialize in healthcare andmedical device issues. Areas of expertise include healthcare complianceprogram structuring and training, as well as advising individualphysician clients. Founding partner Teresa Ford spent many years in themedical-legal arena, most recently prior to starting the firm as seniorcounsel for Sulzer Medica USA Inc. She can be reached at 425-898-2140or tford@tfordlaw.com.Law Offices ofTeresa Ford, PCProud to serve the physician community in matters ofhealth care compliance and business structuring615 Market Street Suite C, Kirkland, WA 98033425.898.2140 (WA office phone)425.307.6561 (WA office fax)www.tfordlaw.com2. Some of the trickier issues include the use of stock or other equitable compensation in connection with work for small start-up device companies, and the use ofroyalties as compensation for strategic guidance and intellectual property utilized in items for which no sales revenue is realized, e.g., computer assisted surgeryhardware and software and certain diagnostic instruments and equipment. More on these issues in a future article.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 11

SURGEON INTERVIEWStephen Snyder, M.D.Redyns Medical, LLCStephen Snyder, M.D., is a surgeon in Van Nuys, California. He became interested inshoulder work early in his career and immediately began performing shoulderarthroscopy. He developed many new techniques for shoulder arthroscopy and hasinvented numerous surgical devices and procedures that are used routinely in modernshoulder surgery. Dr. Snyder founded the International Shoulder Arthroscopy StudyGroup, served on the Board of Directors of the Arthroscopy Association of North Americaand is a member of the American Shoulder and Elbow Surgeons Association. He travelsthroughout the world demonstrating surgical techniques and teaching shoulderarthroscopy and reconstructive surgery. Dr. Snyder is the founder of Redyns Medical, aproduct design and development company with a mission to empower physician inventors.OPN asked him recently about his experience.ORTHOPAEDIC PRODUCT NEWS (OPN): What motivated you toinnovate new products?Stephen Snyder, M.D. (SS): Early in my orthopaedic practice, Imade the decision to start performing shoulder arthroscopy. Atthat time shoulder arthroscopy was just beginning, and althoughthe arthroscopes were reasonably good, the tools necessary to performanything but diagnostic arthroscopy and simple debridementwere not available. It became very obvious after learning tovisualize the anatomy and pathology of the shoulder that ifadvancements were to be made, I was going to have to beinvolved in product development.A good example of this occurred with my first arthroscopic surgicalprocedure in the shoulder, when I was asked to remove twoneedle fragments lodged there following an open rotator cuffrepair. I was excited to be able to see the fragments, but had nocannula system to allow for insertion of an extraction tool, and Ihad no small grasping device that would make retrieval possible.I was able to complete the operation with great anxiety and trepidationby using a surgical hemostat inserted directly through apuncture wound in the shoulder. I ended up losing one of the needlesin the muscle, which required an open incision to remove it.At that time I vowed that I would not settle for performing this orany other arthroscopic procedure without appropriate, trustworthytools. This scenario was repeated with every attempted arthroscopicsurgery, leading to a flurry of thoughts and subsequentproduct ideas to facilitate the intended operation.OPN: What was your early experience in developing products?SS: Initially, I thought that I could simply take a unique idea, filea patent, develop a prototype and then market the finished device,either on my own or through an existing company. One of my firstattempts at “going it alone” was designing a knee positioner. Aftersketching out a rough concept, I worked with a machine shop tocreate an aluminum prototype. Back then there weren’t as manyregulations and restrictions on medical device development asthere are now, so I brought the prototype into the OR to test it out.After applying the patient’s leg to the device, the aluminum positionerbuckled under the weight of the limb. It was then that Idecided that I would need some help, and a different approach.A chance meeting with Barry Bays, a founder of an originalarthroscopy company called Concept, provided the answer. BarryBays was both an engineer and entrepreneur who understood allsides of product development. He became a trusted friend andpartner, and together we produced numerous products from napkinsketches over dinner. The success of that initial venture wasbased on mutual friendship, trust and success.OPN: Where did you go from there?SS: The impetus to start Redyns Medical became apparent whenthe current approach had become more work than it was worth.As a doctor with a full-time job, I found it required too much effortto “shop my ideas around” and, despite my track record, I stillhad trouble convincing industry to develop some of my products.It all came to a head when I tried to convince industry of theimportance of a new technology that was critical to me. I receiveda patent on an arthroscopic-specific post-operative dressing system,which I shared with a number of companies. Unfortunately,without a finished product or even a working prototype, all I hadto demonstrate the concept were the drawings in the patent application.I quickly learned that this was not enough to get the marketingdepartments to see my vision and, as result, all the companiespassed on the opportunity to develop the technology.continued on page 1312 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

SURGEON INTERVIEWcontinued from page 12About that time my son was getting his M.B.A. and needed aproject to work on for one of his classes. I told him about thepatent and he and a few classmates developed a business modelto manufacture the device. After graduation, we started RedynsMedical (Redyns is Snyder backwards) with the short-term goal toproduce the postoperative dressing system. My son Nate and histeam made prototypes, received FDA clearance, manufactured afew thousand units and started selling the product in and aroundsouthern California. The device was named ProWick.After a time, we revisited a number of the companies that hadoriginally turned down the opportunity to develop the technologyand pitched the finished product. Now that they were able tosee and feel the finished device, they became significantly moreinterested in distribution. Ultimately, we decided to partner withArthrex to grow the product’s exposure. Arthrex is currently distributingProWick Shoulder and ProWick Knee exclusivelythrough its sales force around the world.Bolstered by this success, the company went on to develop thebacklog of new technology I had stored up in my “top drawer.”OPN: What is Redyns Medical today?SS: Today, Redyns Medical has evolved into a full-service productdesign and development company with a“Now that theywere able to seeand feel the finisheddevice, they becamesignificantly moreinterested indistribution.”mission to empower physician inventors.Our hope is to rekindle the spirit of the“olden days,” before industry grew so bigand the importance of the physicianinventor grew so small.Developing medical devices is significantlymore challenging now than it waswhen I started practice. Back then,arthroscopy was in its infancy and sopractically any idea we had was “new.”The patent landscape was wide open andthere was no real product competitionalready on the market.Today, hundreds of products exist on the market and thousandsof technologies are described in patents. Whereas when I started,all I had to do was come up with a good idea, now I have to makesure it is not already patented, see if it fits within an industry partner’sproduct portfolio and ensure the finished product makessense from an economic perspective, since reimbursements are solow. Now, we actually need to vet ideas before jumping straightinto development. I quickly realized that with all the time I devoteto my practice that I would need help with product development.Redyns Medical is very good at helping those physician inventorswho wish to remain involved in the product developmentprocess maximize the effectiveness of their efforts. When a physicianinventor comes to Redyns Medical with an idea for a newproduct or surgical technique, we will help him or her evaluate thestrengths and weaknesses of the concept before significant capital isinvested into the development effort. Redyns will consider theintellectual property position, engineering feasibility, product costprofile and potential clinical acceptance of the finished product andprovide the physician inventor a better understanding of the valueof his idea. If the concept has potential, Redyns will offer the physicianinventor a variety of product development options – again, allaimed at keeping the physician inventor in control of the process.Typically, if an idea shows promise, Redyns ends up partneringwith the physician inventor, thereby aligning both parties’ interestsin maximizing the return on investment. The physician inventor isable to invest as much or as little of his own money into the effortand is encouraged to be involved in creating the design requirements,testing prototypes and refining the new surgical techniqueis cadaver labs. Once the technology is designed, developed andtested, Redyns will leverage its industry contacts to identify interestedparties. By having multiple parties involved, the physicianinventor can receive a fair market value on his idea. If, for example,the physician were to work directly with one company, thephysician inventor would receive that one company’s estimate ofthe value of the device, which is oftentimes less than optimal.Redyns Medical’s Physician Services Division was recentlylaunched to help educate physicians on the new product developmentprocess. To this end, I sponsored an instructional coursetitled “Medical Device Development: Protecting andCommercializing Your New Product Ideas” at the ArthroscopyAssociation of North America (AANA) last spring. Joining meon the panel was a patent attorney as well as a co-founder ofRedyns Medical, George Rohlinger. Together, we provided avariety of perspectives on the product development effort.Given the strong, positive reviews from our first course, wehave been invited to host another instructional course at the 2010annual AANA meeting, titled “Empowering the Physician-Inventor.” (The course will address the intricacies of the productdevelopment process, from the napkin sketch to the OR, frominvestment consideration to royalty negotiations.Learn which ideas are primed forsurgical and commercial success and how afull-time physician can get new productideas developed and working.)OPN: What advice do you have for surgeonswho are contemplate developing their own ideasinto products?SS: As far as we’ve come, there’s still a longway to go in developing medical products.When you get into the OR, always think toyourself, “How can I make my job easier?”The litmus test to tell if product development is necessary is tosimply recognize when you are having difficulty with something.I guarantee you, if you’re struggling with a technique or adevice; someone else is struggling as well. Ask yourself, “Whatwould make this easier for me?” Then think through the particulars.Imagine using your new device. What steps would berequired, and in what order? What incisions would you make,and what tools would you need? How is the technique currentlydone, and what are the alternatives? At the end of the day, youmust be the product’s champion–you must believe the idea willwork.As a general guideline, a new technology should enable acommunity-based surgeon to perform a given procedure faster,simpler, safer or cheaper than the way it is currently done. Themore of these adjectives that apply to your idea, the more successfulit is likely to be. By far, physicians are the most qualifiedpeople to invent new products. We are on the front line of thehealth care delivery system. We know better than anyone elsewhat works and what doesn’t.All you need is the idea; there are resources to help you withthe rest. Good luck!Interested parties may contact Dr. Snyder at info@redynsmedical.com.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 13

EXECUTIVE INTERVIEWcontinued from page 14Exhibit 1: Broad array of neckoptions efficiently targets a widerange of patient anatomies.However, it’s not simply about treating the predictably challengingcases. Personalized care is also about addressing theunpredictable anatomical condition or implant position. The innovativesystem of modular necks allows the surgeon to efficientlyrespond intraoperatively to excessive femoral version, muscle laxityor contracture, discrepancies with x-ray templating and unanticipatedcup version, depth or height. The intraoperative flexibilityof independent leg length, offset and version aids the surgeonto equalize leg length, reduce the incidence of impingement andoptimize range of motion unlike ever before.OPN: What effect does the Kinectiv modular head technology have onrange of motion?OPN: How does the M/L Taper with Kinectiv Technology meetZimmer’s commitment to personalized orthopaedics?MM: This system was designed to help surgeons address a widerange of bone morphologies. For example, Exhibit 2 illustratesthat women tend to have lower head centers, less offset andgreater anteversion, whereas men tend to have greater offset andless anteversion. 1-7 The short leg length neck options available inZimmer’s system have been designed for surgeons to address thechallenging varus femoral anatomy, commonly seen in femalepatients, without having to perform low, bone-sacrificingosteotomies to restore leg length. These gender-specific tendenciesare profound, but we also recognize that there is a wide anatomicalvariation within male and female populations. These areaddressed by offering head centers that better match the full rangeof anatomies for both men and women. Our system offers 60 headcenter solutions with five offset options for a given leg length, fiveleg length options for a given femoral offset in 4mm increments,and anteverted and retroverted options for each leg length/offsetcombination.MM: The keystone to Kinectiv Technology is the use of +0 femoralheads exclusively. Range of motion and joint stability are primaryissues in total hip replacement. With the sole use of the +0 head,every neck geometry has been optimized to this head length tobenefit range of motion. This also eliminates the use of skirtedfemoral heads that are necessary for the longer offset option incompeting systems. The ante/retroverted necks allow the surgeonto intraoperatively fine-tune the range of motion depending onthe patient anatomy and implant position. (See Exhibit 3.) The versatilityof a modular neck system allows the surgeon to restore leglength, offset and version to create a well balanced soft tissue environment.By combining the most accurate head position with thebest neck option for the patient, surgeons can optimize range ofmotion and minimize the likelihood of instability and dislocation.Exhibit 3: Anteverted neck resolves neck impingement.Exhibit 2: Plotting head height and offset reveals two distinct populations:female and male.OPN: Is there anything further about the Zimmer M/L Taper withKinectiv Technology?MM: I think it’s important to stress that Zimmer offers thisincreased flexibility to surgeons without introducing increasedcontinued on page 1816 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

EXECUTIVE INTERVIEWcontinued from page 16complexity. We’ve kept it simple. The Kinectiv Technologyimplants and instrumentation have been designed with significantconsultation from surgeons, O.R. personnel and sales representatives.Our goal was a streamlined, simple option for bothsurgeon and patient. Our sole use of the +0 heads gives the systemthat simplicity and eliminates the need for multiple head lengths,complicated charts and head size limitations. We have been quitepleased by the response from surgeons and O.R. teams who havefound that the intuitive and readily apparent 4mm leg length andoffset adjustments help improve operative flow.OPN: Zimmer isn’t the first to develop a mobile bearing knee implant.Why a new generation of mobile bearing knees?HP: There have been several generations of mobile bearingimplants, and as an industry we’ve learned that, for certainpatient demographics, a mobile bearing option can provide amore natural range of motion. As the market leader in total kneearthroplasty, we feel it’s imperative to offer a solution for this marketsegment that builds on the clinical legacy of our NexGen KneeSystem while offering unique and value added technologies. Thenext step is improving upon patient satisfaction and the implantfunction and performance expectations. To this end, the NexGenLPS-Flex Mobile Bearing Knee System (See Exhibit 4.) wasdesigned to accomplish three main goals: (1) to restore naturalkinematics, (2) to accommodate safe flexion to 155˚, and (3) toenable surgeons to utilize Minimally Invasive Solutions procedures.Exhibit 4: The NexGen LPS-Flex Mobile Bearing Knee System.HP: The NexGen LPS-Flex Mobile Bearing Knee System was theresult of our analysis of the effects and component interactionsthat result when knee prostheses undergo deep flexion, beyond120˚. Zimmer’s design allows for safe high flexion as the posteriorcondyles roll back up to 155˚. This higher flexion meets theneeds of patients with active daily living, leisure or work activities,as well as patients whose culture or social customs dictate frequentkneeling or sitting cross-legged.Antecedent mobile bearing designs have failed to address seriousfunctional limitations arising from the kinematics of kneerotation. The problem with competing mobile bearing implantsarises from the central location of the pivot point on the tibialbaseplate.Zimmer has designed the NexGen LPS-Flex Mobile BearingKnee with an anterior pivot (See Exhibit 5.), which is where bodymechanics tell us it should be – near the anterior cruciate ligamentsite. Anterior pivoting replicates the anatomic center of rotationand reduces patellofemoral forces. 8-11 Patellofemoral forces alsoincrease with greater medial/lateral displacement, which researchhas implicated in post-surgical anterior knee pain. Reduction inpatellofemoral forces could reduce patellar complications such aspatellar dislocation, component wear, damage and loosening. 8,9 Ananterior stop on the tibial baseplate effectively prevents the “spinout”seen in competing implants and noted in the literature. 12,13 Inregards to design features which facilitate minimally invasive surgicalapproaches, the height of the anterior trunnion is only10mm, which in combination with our “mini keel” tibial baseplate(See Exhibit 6.) reduces the need for tibial subluxation to insert thecomponents. Another key feature is Zimmer’s enhanced PScam/spine mechanism which, unlike most PS systems, drivesdown the spine of the articular surface, increasing resistance tosubluxation.Exhibit 5: The NexGen LPS-Flex Mobile Bearing KneeSystem with an anteriorpivot point.OPN: Tell us more about the benefits of the NexGen LPS-Flex MobileBearing Knee.OPN: Some companies claim that bone conservation is a key factor inhigh-flex knee implants. These companies criticize femoral designs suchas the LPS-Flex because an additional 2mm of bone must be removedfrom the posterior condyles compared to the standard femoral designs.HP: While bone conservation is always important, Zimmerresearch has shown the removal of an additional 2mm of bone isrequired to optimize the tibiofemoral contact area (See Exhibit 7.)continued on page 1918 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

EXECUTIVE INTERVIEWcontinued from page 18Exhibit 6: Mini keel tibial baseplate.HP: The NexGen Mobile Bearing Knee flexibly accommodates differentsurgical styles, and can be accomplished through a minimallyinvasive procedure which results in smaller incisions, lessblood loss and less pain. The Zimmer Multi-Reference® 4-in-1Instrumentation allows for a measured resection technique.Alternatively, the Zimmer Minimally Invasive SolutionsIntramedullary Instrumentation accommodates a tibia-first, flexionbalancing approach. Regardless of the surgical technique, thisprecise instrumentation allows surgeons to adjust and controlalignment prior to performing any bone cuts.OPN: What’s next for Zimmer?throughout the entire range of motion. An implant system thatprovides a greater tibiofemoral contact area during high flexioncan help minimize the possibility of edge loading, and therebyreduce the likelihood of the metal condyle “digging” into thearticular surface when the knee is flexed beyond 125˚. 14 On theNexGen LPS-Flex implants, this was accomplished by extendingthe radius of the posterior femoral condyles so the contact arearemains high in deep flexion.Exhibit 7: Research shows the removal of an additional 2mm of bone isrequired to optimize the tibiofemoral contact area throughout the entirerange of motion.To extend the radius, the posterior condyles are slightly thicker,which also increases the posterior condylar offset, and thusreduces the chance of impingement of the femoral shaft on the tibialarticular surface. 15 Some competitors, such as the StrykerTriathlon Knee, for example, claim to be “high-flex friendly.”However, our own head-to-head research has shown that theTriathlon Knee has significantly less contact area when comparedto the NexGen Flex Implants at high flexion angles between 125˚and 155˚. 14OPN: Let’s talk about the procedure. What kind of instrumentation andprocedure options are there for surgeons in implanting the NexGenMobile Bearing Knee?HP: We are currently developing new products and technologiesacross all of our reconstructive lines, with some exciting offeringscoming out of the extremities category, as well as knees and hips.We are also continuing to build our global spine, trauma and dentalbusinesses. As we continue to grow across all divisions, we arealso investing in orthobiologic technologies and advanced materials,allowing us to address more of the continuum of care for jointdisease.MM: In parallel with our innovations in orthopaedic solutions, wewill continue to expand our offerings at the Zimmer Institute,which is setting the standard in the industry for personalized andhands-on surgical training.References1. Noble PC, Box GG, Kamaric E, Fink MJ, Alexander JW, Tullos HS. The effectof aging on the shape of the proximal femur. Clin Orthop. 1995;316:31-44.2. Maruyama M, Feinberg JR, Capello WN, D’Antonio JA. Morphologic features ofthe acetabulum and femur: anteversion angle and implant positioning. ClinOrthop. 2001;393:52-65.3. Data from Mohamed Mahfouz, Ph.D., University of Tennessee Center forMusculoskeletal Research. Femoral Bone Atlas.4. Data on file at Zimmer.5. Sugano N, Noble PC, Kamaric E. Predicting the position of the femoral headcenter. J Arthroplasty. 1999;14:102-107.6. Dorr LD, Long WT, Inaba Y, Sirianni L, Boutary M. MIS total hip replacementwith a single posterior approach. Seminars in Arthroplasty. 2005;16:179-185.7. Malik A, Maheshwari A, Dorr LD. Impingement with total hip replacement. JBone Joint Surg. 2007;89:1832-1842.8. Smith AJ, et al. Pre-surgery knee joint loading patterns during walking predictthe presence and severity of anterior knee pain after total knee arthroplasty. JOrthop Res. Number 22, pp 26-266. 20049. Browne C, et al. Patellofemoral forces after total knee arthroplasty: effect ofextensor moment arm. Knee. Number 12, pp 81-88. 2005.10. Scuderi GR et al. In vivo kinematic evaluation and design considerations relatedto high flexion in total knee arthroplasty. J Biomech. Number 38, pp 277-284. 200511. Hollister AM, et al. The Axes of Rotation of the Knee. Clin Orthop Relat Res.Number 290, pp 259-268. 199312. Stiehl JB. Clinical results and complications in mobile bearing total kneearthroplasty. Instr Course Lect 2005;55:233.13. Thompson N.W., Wilson DS, Cran GW, et al. Dislocation of the rotating platformafter low contact stress total knee arthroplasty. Clin Orthop. 2004;425:207.14. Data on file at Zimmer.15. Bellemans J, Banks S, Victor J, Vandenneucker H, Moemans A. Fluoroscopicanalysis of the kinematics of deep flexion in total knee arthroplasty: influence ofposterior condylar offset. J Bone Joint Surg (Br). 2002; 84-B(1):50-53.For more information, please contact CRM@zimmer.com.Note: All trademarks are the property of their respective owners.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 19

PRODUCT NEWS AND LAUNCHESAxial Biotech announced commercial availability of theSCOLISCORE Adolescent Idiopathic Scoliosis PrognosticTest to U.S. spine specialists. DePuy Spine markets theproduct.(Axial Biotech, Inc., 9/24/09)SmartDriver DuoCardo Medical marked the introduction and 1st successfulimplantation of the Align 360 Total Knee system.Commercial release to an expanded surgeon network willoccur over upcoming quarters.(Cardo Medical, Inc., 10/7/09)Celling Technologies launched the Res-Q device, developedby ThermoGenesis as a point-of-care system to complementtheir MXP system. Res-Q utilizes a functionally closed systemdesigned to eliminate sterility issues while providing adultstem cell concentrations within minutes.(Celling Technologies, 10/12/09)DePuy Mitek launched the VAPR Premier90 small-diameterradiofrequency electrode for arthroscopic tissue removal inthe knee, shoulder, ankle, etc.(DePuy Mitek, Inc., 10/13/09)Extremity Medical commenced limited release of the TarsXIntramedullary Midfoot Fusion Device in the U.S.(Extremity Medical, LLC, 10/2/09)Innovative Medical Products introduced the Phase 4 Gelforearm traction splint for use in shoulder and elbowarthroscopy.(Innovative Medical Products, 9/23/09)Integra LifeSciences launched a smaller configuration of itsAccell Evo3® Demineralized Bone Matrix (DBM). The smallsize expands the product's application, particularly inprocedures that require smaller amounts of DBM.(Integra LifeSciences Corporation, 9/29/09)K2M launched NATURAL BRIDGE® Low Profile TransverseConnectors for use in stabilization of the thoracolumbarspine. NATURAL BRIDGE incorporates adjustable and semiadjustabledesigns for use with K2M’s RANGE®, MESA® andDENALI® Spinal Systems.(K2M, Inc., 9/15/09)LDR noted that, to date, >3,000 devices with VerteBRIDGEplating technology have been implanted worldwide, with>2,500 occurring in the U.S. The devices include the ROI-AAnterior Lumbar Interbody Fusion and the ROI-C Cervicalcages.(LDR Holding Corporation, 11/2/09)MicroAire Surgical Instruments released the SmartDriverDuo, a cordless handheld orthopaedic power instrumentfeaturing dual-triggers to control the operation of the instrument’svarious attachments. The SmartDriver Duo smallbonetrauma system is used primarily during procedures onmedium and small bones in the hand, foot and shoulder.MicroAire developed the variable-speed, multi-purpose handpiece with a selection of quick-connect drive couplers fordrilling, sawing, reaming, wire and pin driving, osteotomiesand pulse lavage. The two triggers can be pressed separatelyto control cyclical operation, or simultaneously to controloscillating operation. The instrument is powered by a 14.4volt Nickel Metal Hydride (NiMH) battery housed in a sterilepack.MicroAire Surgical Instruments LLCTel: 434-975-8000www.microaire.comMEDICREA launched the PASS® LP De-Rotation connector inthe U.S. In 2010, the company will commence a 3-year U.S.prospective multicenter clinical study analyzing the 3Dcorrection of adolescent idiopathic scoliosis by posteriorinstrumentation. Initial results will be published by the end of2011.(MEDICREA, 9/24/09)November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 23

PRODUCT NEWS AND LAUNCHESCortoss Bone AugmentationMaterialScient’x launched the Isobar Evolution Dynamic Rod as anadjunct to posterior pedicle-based fusion. The device isintended for use with the Scient’x Xenonx Pedicle Screw inthe U.S. and will be compatible with several of the company’spedicle screw systems worldwide.(Scient’x Groupe S.A.S., 9/28/09)Osteotech's MagniFuse PC (Posterior Cervical) Bone Graftwas used for the 1st time in a spinal surgery in the U.S.(Osteotech, Inc., 10/28/09)Cortoss is an injectable, bioactive composite that mimicsthe mechanical properties of human cortical bone and thefirst alternative to polymethylmethacrylate (PMMA) cementevaluated in a large-scale, prospective, multi-center, randomizedcontrolled study used for the treatment of vertebralcompression fractures.Data from the IDE study prospectively comparing Cortossand PMMA show that the therapeutic flow and fill of Cortossresults in:• A statistically significant improvement in VAS score at 3months (11.6%, p

CAPITOL HILL UPDATEOrthopaedic Surgeon EntrepreneurAnnounces Bid for U.S. CongressOctober 1, 2009 - Press ReleaseBLAKE CURD ANNOUNCES CANDIDACY FOR SOUTH DAKOTACONGRESSIONAL SEAT“…there is too much Washington in South Dakota. It’s time to take more South Dakota toWashington.”(Sioux Falls) – Dr. Blake Curd, Sioux Falls physician andRepublican member of the South Dakota State House ofRepresentatives, today announced the filing of his Statement ofCandidacy with the Federal Elections Commission for the 2010election for South Dakota’s At-Large Seat in the United StatesCongress. Dr. Curd, 42, was elected to the State House representingDistrict 12 in Lincoln and Minnehaha counties in 2008, and isan Orthopedic, Hand and Microvascular surgeon practicing inSioux Falls.“As a doctor, it is my work to heal sick and injured peopleevery day. As a Congressman, I will work to heal a very sick andinjured federal government. These days there is too muchWashington in South Dakota. It’s time to take more South Dakotato Washington,” said Curd.“As South Dakota’s elected Representative I will work torestore our Congress to its intended form, one that listens to andrepresents the people I am privileged to serve. We cannot mortgageour way to success and prosperity. I will work tirelessly torestore true fiscal responsibility to our nation while ensuring thatthe federal government does not continue to trample on our freedomand liberty under the ruse of protecting and caring for us. Wemust curtail pork barrel spending, earmarks, and legislativearrangements that reward the few while hurting the country andSouth Dakota. We must seriously pursue energy independence.We must promote policies that encourage us to turn to each otherfor assistance when help is needed and away from increasingdependence on government solutions.”“For decades Congress has inserted the federal governmentever deeper into the lives of our citizens under the guise of assistanceand compassion, the result of which has been a gradual yetconstant erosion of our freedom and liberty.Congress continues to demonstrate that its appetite is insatiableand is dangerously close to accumulating a debt thatAmerica will never be able to repay and shackling future generationswith the chains of that irresponsibility. This must end andthis must be reversed.”“Regardless the outcome of the current bills before ourCongress, health care will continue to be a significant issue. TheDemocrats will continue to try and insert government in the personaland private relationships between ourselves and our doctors,dictate what health insurance we must have, and what treatmentswe can afford. We need people that have fought forpatients, fought against disease, fought for what is right when theinsurance industry has denied treatment, and stood up to the statusquo to improve our health. As a member of Congress I willdeliver real experience to health care and promote real solutionsthat work and are effective.”“Elections are about choices. I believe the people of SouthDakota deserve a choice between the current representation and afresh new perspective on the federal government and its role inthe betterment of the lives of our citizens. I look forward to a vigorousdebate on the issues and challenges facing South Dakotawith the current representative, Stephanie Herseth Sandlin,” concludedCurd.Curd served in the United States Air Force, was stationed atEllsworth AFB for a time, and moved to Sioux Falls in 2001. Heand his wife Debbie have been married for 16 years and are theparents of three children. They attend Celebrate Church in SiouxFalls. A full biography of Dr. R. Blake Curd follows and is availableat www.CurdforCongress.com.(Paid for by Curd for Congress)Biography of R. Blake Curd, M.D.R. Blake Curd, M.D. is an Orthopedic, Hand, andMicrovascular Surgeon practicing at the Orthopedic Institute inSioux Falls, South Dakota. He is the immediate past chairman ofthe Department of Orthopedic Surgery at Avera McKennanHospital and University Health Center.Dr. Curd was born to Richard A. and Nancy L. Curd in Atlantic,Iowa, and reared in Omaha, Nebraska and the Greater Kansas CityArea. His father served a long and distinguished career in bothState and Federal Law Enforcement. His mother was an internationalentertainer who became a stay at home mom raising Blakeand his brother Derek who is an electrical engineer currently livingin Niwot, CO.continued on page 2726 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

CAPITOL HILL UPDATEcontinued from page 26Curd graduated from the University of Missouri at Kansas CitySchool of Medicine with degrees in Biology, Chemistry, and hisMedical Doctorate. He completed an Internship at David GrantMedical Center, Travis AFB, CA and a residency in OrthopedicSurgery at Wilford Hall Medical Center, Lackland AFB, TX. Curdcompleted a Fellowship in Hand and Microvascular Surgery atIndiana University and the Indiana Hand Center. He is anAssociate Professor for the Sanford School of Medicine.Curd began his career in the United States Air Force Reserve in1987. He entered active duty service in 1991 and was honorablydischarged with the rank of Major in 2000. Curd was stationed atTravis AFB, CA, Ellsworth AFB, SD, Lackland AFB, TX, and CampPendleton, CA. During his time in the service Curd completed hismedical training in Orthopedic Surgery and deployed to theMiddle East and the Pacific Theater. While stationed at EllsworthAFB he deployed to Kuwait where he was assigned to a combatsearch and rescue squadron in support of Operation SouthernWatch. As a Flight Surgeon Curd has logged hours in the T-37, T-38, HH-1H Huey helicopter, HH53 Pavelow helicopter, HH55Pavehawk helicopter, KC-10, KC-135, B1, B52, C130, C5, and C141.Curd is Chairman of the Board and Interim President ofSurgical Management Professionals. He serves as Manager forMedical Facilities USA, and is a member of the Acquisition committeefor Medical Facilities Corporation. Curd is a member of theboard and current Treasurer for Physician Hospitals of America.He ran for the South Dakota House of Representatives in 2008winning a four-way primary in May and was elected to office inthe November General Election. He is currently serving his firstterm in the South Dakota House of Representatives and is on theLocal Government and Health Committees.Blake has been married to Debbie Curd, a registered nurse,for sixteen years. The couple have three children: Elliott, 13,Rilie, 11, and Zachary, 7. The family attends Celebrate Church inSioux Falls.(Paid for by Curd for Congress)November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 27

FUTURETECHEmerging Orthopaedic Technologies & TreatmentsRecent FDA ClearancesAugust and September 2009AngleFix T Locking Plate (ANGLEFIX TECH)Osteoselect Demineralized Bone MatrixPutty(BACTERIN)Spinal Foraminoscope(BLAZEJEWSKI MEDI-TECH)Anterior Cervical Plate (CARDO MEDICAL)Regent Anterior Cervical Plate(CUSTOM SPINE)Equivabone Osteoinductive Bone GraftSubstitute(ETEX)Truss Thoracolumbar Plate(GLOBUS MEDICAL)PCT Spinal System(GOLD STANDARD ORTHOPAEDICS)Michelangelo Bunion System (INSTRATEK)Sentinel Spinal System(LIFE SPINE)Robotic Arm Interactive Orthopedic System(MAKO SURGICAL)Freedom Total Knee Cruciate Retaining FemoralComponent (MAXX ORTHOPEDICS)Aptus K-Wire System(MEDARTIS)Asfora Bullet Cage System(MEDICAL DESIGNS)KneeAlign SystemArthroscope(ORTHALIGN)(ORTHOPEDIC SCIENCES)PEEK CF Interference Screw and V-LoxPEEK Suture Anchor (PARCUS MEDICAL)Monopoly Pedicle Screw (SIGNUS MEDICAL)WavEon WRx Bone Fixation System(SONOMA ORTHOPEDIC PRODUCTS)Tryptik CA Anterior Intersomatic CervicalCage(SPINEART)Dorado Wide Intervertebral Body Cage(SPINEFRONTIER)SIGN Hip Construct(SURGICALIMPLANT GENERATION NETWORK)FDA 510(k) Releasable Database, 8/09 and 9/09The National Institutes of Health will award 15 grants to support the Patient ReportedOutcomes Measurement Information System (PROMIS), an initiative that usescomputer technology and measurement theory to assess pain, fatigue and otheraspects of quality of life in a standardized manner. PROMIS is managed by theNational Institute of Arthritis and Musculoskeletal and Skin Diseases.(NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases, 10/19/09)Studies indicate that direct injections of recombinant human lubricin significantlyreduced cartilage degeneration in a rat model of post-traumatic osteoarthritis. Lubrisis developing the product for orthopaedic and other indications.(Biomodels LLC,10/19/09)RSB Spine received FDA clearance of its InterPlate® C-Ti for a new indication. Thedevice is now reportedly the 1st interbody fusion device to be cleared as an anteriorcervical plate. (RSB Spine, LLC, 10/12/09)Pre-clinical research revealed that SANUWAVE's Pulsed Acoustic Cellular Expression(PACE) technology can stimulate proliferation and thickening of osteoprogenitorstem cells for harvest and re-transplantation in bone tissue engineering applications.(SANUWAVE, Inc., 10/13/09)Impliant has conducted the first 2 implantations using its TOPS VersaLink, abilateral titanium lumbar fusion system. (Impliant, Inc., 10/9/09)OrthAlign received FDA 510(k) clearance to market the KneeAlign disposablecomputer-assisted surgical navigation system for total knee arthroplasty.(OrthAlign, Inc., 10/7/09)Suspension Orthopaedic Solutions raised US $2.3MM which will supportdevelopment of shoulder and knee implants (for example, the Suspension FractureFixation System). The company anticipates bringing product to market by mid-2010.(Baltimore Business Journal, 10/6/09)Studies suggest that early outcomes appear to be promising from the use of plateletrichplasma as an alternative treatment for orthopaedic-related sports medicineconditions, though larger clinical studies are needed to determine the benefits of its use.(American Academy of Orthopaedic Surgeons, 10/1/09)Studies suggest that supervised exercise may result in better outcomes thanshockwave treatment for relieving chronic shoulder pain. After 18 weeks, 64% ofpatients in the exercise group had reduced pain and disability, vs. 36% of thosereceiving shockwave therapy. (HealthDay News, 9/16/09)Studies suggest that people who have suffered a torn anterior cruciate ligament maybe more likely to have a smaller ligament than similarly-sized people who have neverinjured a knee. (Ohio State University, 9/14/09)A research team at Virginia Tech won a US $0.3MM grant to study knee ligamentsprains at the micro-mechanical level. The findings could support the creation ofreplacement grafts and biological scaffolds for damaged ligaments, as well as guidethe design of braces or stretching routines. (Virginia Tech, 9/10/09)Kapstone Medical acquired from Spherofix the exclusive rights to a suite of fixationtechnology. Kapstone is pursuing the development of multiple projects involvingspinal products. (Kapstone Medical, LLC, 9/10/09)FDA has cleared Covidien's DuraSeal spine sealant for use as an adjunct tosuturing for intra-operative dural sealing. (Covidien, 9/8/09)28 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

ORTHOINVESTOR UPDATETicker Track (Based on close of business, 9/30/09)Ticker 52-Wk 52-Wk Chg vs. Chg vs.Company Symbol High Low Close Prior Mo. Prior Yr.aap † AAQ 3.18 1.33 1.74 -4.4% -33.1%Alphatec Holdings ATEC 5.51 1.10 4.60 0.4% 0.0%ArthroCare ARTC.PK 31.00 2.89 20.39 15.9% -26.4%BioMimetic Therapeutics BMTI 13.56 4.69 12.21 3.7% 10.4%co.don AG † CNW 1.31 0.55 0.74 -6.3% 20.4%ConMed CNMD 31.63 11.56 19.17 7.5% -40.1%Corin Group †† CRG.L 1.97 0.52 1.08 2.9% -49.1%curasan † CUR 5.17 1.78 4.20 1.9% 51.1%Exactech EXAC 21.10 10.74 15.74 5.8% -29.2%Inion †† IIN.L 0.19 0.00 0.01 0.0% -92.9%Japan MDM § 7600 4.13 1.36 3.17 37.8% 28.3%MAKO Surgical MAKO 10.00 5.23 8.76 2.5% 20.8%NuVasive NUVA 51.17 24.17 41.76 4.2% -15.3%Orthofix OFIX 30.47 8.65 29.39 7.4% 57.8%Orthovita VITA 6.91 1.49 4.39 4.0% 68.8%Osteotech OSTE 5.04 1.31 4.45 3.0% 4.5%ReGen Biologics RGBO.OB 5.90 0.00 0.93 -48.3% -69.0%RTI Biologics RTIX 9.38 1.30 4.35 -4.4% -53.5%Smith & Nephew SNN 49.39 30.01 45.03 6.6% -15.1%Stryker SYK 62.92 30.82 45.43 9.6% -27.1%Symmetry Medical SMA 17.83 3.90 10.37 -5.9% -44.1%Synthes ‡ SYST 149.07 99.44 116.70 -1.6% -15.2%TiGenix † TIG 8.08 3.15 6.50 2.8% 56.3%TranS1 TSON 10.03 4.08 4.81 2.1% -51.4%Company Financials †2Q09 vs. 2Q08Company Sales vs.($MM) PriorALPHATEC $32.3 +35%U.S. $26.4 +36%Asia $5.5 +21%Europe $0.4MAKO Surgical $14.9ORTHOVITA $24.5 +27%SYMMETRY $101.0 -8%Instruments $46.9 +4%Implants $29.9 -4%Cases $18.9 -19%WRIGHT MEDICAL $118.9 +3%Hips $41.0 +2%Knees $30.2 -1%Biologics $19.5 -4%Extremities $25.6 +19%Other $2.5 -36%OTHER FINANCIAL PERIODSCompany Sales vs.($MM) PriorCORIN 1st Half $32.9 †† -25%Hips $15.8 -45%Knees $8.5 -7%Other Products $8.5 +37%MEDTRONIC1st Quarter Fiscal 2010, ended 7/31/09Spinal $915.0 +8%Core Spinal $696.0 +11%Biologics $219.0 flat(Company news releases, 8/09)†Orthopaedic product sales only.††£20.1MMWright Medical Group WMGI 28.99 11.17 17.86 10.0% -41.3%Zimmer Holdings ZMH 62.40 30.67 53.45 12.9% -17.2%†Converted from Euro to USD; 1€ = 1.4654 USD.††Converted from British Pound to USD; 1£ = 1.5941USD.‡Converted from Swiss Franc to USD, 1CHF = 0.9693 USD.§Converted from Yen to USD, 1¥ = 0.0112 USD.In order for a company to qualify for inclusion in the Orthoinvestor Update, orthopaedics must representat least 60% of its revenues.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 29

FUTURETECHThromboembolic DiseasePrevention in Spine Surgery: TheRole of a Novel PneumaticCompression DeviceAuthor: Isador Lieberman, M.D., M.B.A., F.R.C.S.C.Venous thromboembolic (VTE) disease is a common complicationof total joint arthroplasty that has been recognized since theNational Institutes of Health consensus conference in 1986. Withoutprophylaxis, the rate of deep venous thrombosis (DVT) after totaljoint arthroplasty ranges between 40 percent and 85 percent,depending on the surgical procedure involved. Since 90 percent ofsymptomatic pulmonary emboli (PE) are estimated to originatefrom lower extremity DVT, prevention of DVT has become thestandard of care after total joint interventions. 1Despite the medical consensus that exists around this issue, thegap between current practice and optimal practice is large, and PEis still the most common preventable cause of death in the hospital.An estimated 10 percent of in-hospital deaths are secondary to PE—more annual deaths than those from breast cancer, AIDS and trafficaccidents combined. 2The high prevalence of hospital-acquired VTE is largely due tothe underutilization of the currently recommended prophylacticprotocols. Excellent methods of chemoprophylaxis using warfarin,low-molecular-weight heparin (LMWH) or fondaparinux areavailable. Chemoprophylaxis, however, carries a bleeding risk ashigh as five percent. Mechanical methods of prophylaxis, mainlyintermittent pneumatic compression (IPC) devices, continue to be anattractive option because very few complications have been identifiedwith their use. However, the benefits of mechanical devices arelimited by poor compliance, and the potential benefits have not beenproven in clinical trials vs. commonly used anti-coagulants.Consequently current recommended prophylaxis protocols arebased on anticoagulants, and the use of mechanical prophylaxis isrelegated to those patients with higher bleeding risk or as an adjunctto anticoagulant-based prophylaxis. 1 The decision-making processthat led to the above recommendations was based upon “fearbalance” between postoperative VTE risk and bleeding risk.While the risks for VTE and bleeding in lower extremityorthopaedic surgery have been studied intensively and are welldefined, the risks during spinal surgery are not yet well defined.Likewise, the true incidence of thromboembolic and bleedingcomplications in spinal surgery remains largely unknown. Byvirtue of the previously mentioned issues and the diversity ofspinal procedures, it is not really possible to suggest a standardizedevidence-based prophylactic regimen in this specific orthopaedicfield. Not surprisingly, recently published survey studies thatexplore U.S. spine surgeons’ practices regarding postoperativethromboprophylaxis after high-risk spinal surgery demonstratedwide variability in the prophylaxis regimen used, and highlightedthe fact that the surgeons’ decision-making process was morecommonly based upon personal experience than evidence-basedreview. 3 In this study, 61 percent of the surgeons used LMWH forDVT prophylaxis, followed by unfractionated heparin (18 percent)and coumadin (12 percent). However, because of the increased riskfor bleeding with the use of anticoagulants and fear of the potentialcatastrophic outcome of epidural hematoma, chemoprophylaxiswas usually delayed, with the most common delay-interval being48 hours post-surgery. This common practice might significantlyaffect the chemoprophylaxis efficacy, as it is well established in theliterature that about 50 percent of the DVT actually starts on theoperating table and, after 24 to 48 hours, 86 percent of eventuallypositive limbs are already positive. 4,5,6 As an alternative or anadjunct treatment, many spine surgeons use inferior vena cava(IVC) filters, on an individual case basis, to avoid chemoprophylaxisor act as a failsafe in preventing PE. The use of IVC filtersnegatively alters the cost-effectiveness profile of the prophylaxis,and use is currently not supported by clinical data. 3The above study emphasizes the current practice in high-riskspine surgery and reflects the fact that, up to now, no precise indicationshave been published relating to VTE prophylaxis in spinesurgery, with spine surgeons having to rely on generic recommendationsfrom general orthopaedic surgery and neurosurgery.Despite the lack of information, the incidence of VTE afterspinal surgery appears to be considerably lower than thatfollowing major lower-extremity surgery. Pooling data from 25relevant studies, Glotzbecker et al. 7 found that the overall rate ofDVT ranged from 0.3 percent to 31 percent, with a variability thatis likely the result of disparate patient populations, suggestingthat some subgroups of patients seemed to be at high enough riskto consider thromboprophylaxis.Possible risk factors for VTE following spine surgery includeincreased age, obesity, previous VTE, an anterior surgical approach,malignancy, a prolonged procedure and reduced preoperative orpostoperative mobility. Urgent surgery and multiple-traumafurther increase the risk. Taking into account demographic changesin the U.S. population, which is becoming older and obese, one caneasily expect a trend toward an increased incidence in patients’DVT risk scores.continued on page 3230 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

FUTURETECHcontinued from page 30The 8th Association of Corporate Contributions ProfessionalsConference on Antithrombotic and Thrombolytic Therapyrecommended the following guideline for VTE prophylaxis afterelective spine surgery: 1• For patients considered being low-risk patients: early andfrequent ambulation.• For patients undergoing spine surgery who have additionalthromboembolic risk factors: postoperative low-dose unfractionatedheparin, or postoperative LMWH, or optimal use ofperioperative IPC. An alternative consideration is gradedcompression stockings.• For patients who have multiple risk factors for VTE: a pharmacologicmethod should be combined with the optimal use of amechanical method.Glotzbecker et al. 7 in a recently published review article suggestedthat optimal mechanical prophylaxis should be used routinely in mostpatients, while in higher risk patients, administration of a chemicalprophylactic agent and/or use of an IVC filter may be considered.According to the authors, the supporting data for use of anticoagulantsand the IVC filter and the optimal timing of chemoprophylaxisinitiation and duration are very limited, and therefore the exactprotocol continues to be controversial. Glotzbecker’s recommendationsand conclusions are in agreement with the current NorthAmerican Spine Society guidelines for thromboprophylaxis. 8The major disadvantage in the use of anticoagulants for DVTprevention is the increased bleeding risk associated with theirroutine usage. In spinal surgery, as in brain surgery, even minorbleeding may cause catastrophic results and permanent disability.The two most frightening complications of spine surgery are onsetof an epidural hematoma with its potentially tragic complications(not always reversible, even after an immediate revision anddecompression) or a deep hematoma with a consequent infection.Platzer et al. 9 found a postoperative epidural hematoma rate of0.6 percent and a minor bleeding rate of two percent in 978 traumapatients who underwent spinal surgery; of these, 945 patientsreceived LMWH after surgery, though the time at which it wasinitiated was not reported. Thorough literature review confirmedthat the incidence of postoperative epidural hematoma after spinesurgery is less than one percent. 7Spine surgeons have to weigh the risk of a symptomatic postoperativeepidural hematoma against the benefit of DVT/PE preventionwhen deciding to initiate chemoprophylaxis and, in theabsence of universally accepted guidelines, surgeons are reluctantto initiate chemical anticoagulants immediately after spinal surgery.Thus, anticoagulation is frequently delayed for a period of timeuntil the risk for postoperative bleeding is perceived to besufficiently low. As already mentioned, this delay in prophylaxisinitiation may lead to suboptimal DVT prevention.Another option that the spine surgeon my take in this situationis to completely avoid the VTE prophylaxis. Janku 10 in survey studyfound that only 21 percent of spine surgeons used prophylaxis in allpatients, a further 21 percent used it only in “high-risk” cases and58 percent of surgeons did not employ any kind of prophylaxis.This classic dilemma of the surgeon, forced to choose between avery potent chemoprophylaxis that carries an increased risk ofbleeding and a mechanical-prophylaxis that may be less effectivebut much safer, may now have a solution with a recentlydeveloped, portable, battery-operated lower extremity pneumaticcompression device. The device is able to synchronize its compressionactivity to the respiratory related venous phasic flow. Theclinical efficacy and safety of this new device were proven to bevery high in several prospective, randomized clinical studies thatalso demonstrated its superiority over both standard IPCs andLMWH (Lovenox). The system seems to offer patients and surgeonsoptimal DVT prevention without the exposure to bleeding complicationsassociated with the use of anticoagulants.The device, called ActiveCare+SFT® (Synchronized FlowTechnology), combines a miniature mobile unit with compressionsleeves that can be easily wrapped around the patient’s leg or footduring and after surgery. (See Exhibit 1.) It weighs 1.65 pounds andcan be operated either by battery or wall socket. It was designed toprovide Continuous Enhanced Circulation Therapy (CECT) andrepresents a new category of mechanical devices.Exhibit 1:Mobile Compression UnitThe system identifies thepatient's venous blood flowpulses and its compression isthen synchronized to thesenatural rhythms. Thistechnology allows significantamplification of the venousflow pulsatility 11 with onlyminor changes in the deviceimpact on the legs, thusproviding gentle pressure which delivers an optimal hemodynamicprofile tailored to the patient’s specific physiology. The production ofhigher blood flow speed and pulsatility generated by the device, itscompact size and the fact that it can be used 24/7 throughout the entirehigh-risk period (both in the hospital and post-discharge) give it adefinite advantage over traditional IPCs, as was demonstrated in aprevious total joint arthroplasty study performed at the ClevelandClinic. 12 The device's compact design, which allows patients to be freelyambulatory, has resulted in a dramatic 50 percent increase in patientcompliance compared to IPC systems. 13,14 Patient compliance can bemonitored on the LCD screen, thereby providing critically importantfeedback for caregivers, physicians and patients themselves.The combination of this increase in usage compliance with uniqueimproved hemodynamic profile was shown, in three different clinicaltrials, to significantly increase the device’s clinical effectiveness inDVT prevention. All three clinical trials were performed on high-riskorthopaedic patients with VTE as the primary endpoint. In the first,the new CECT device was studied against standard IPC, when bothdevices were used over LMWH. The replacement of the IPC with theCECT device caused a 70 percent relative risk reduction. (Seesummary at the end of this article.) 12The second study compared the CECT head to head withLMWH and demonstrated a 77 percent relative risk reduction in theCECT group. (See summary at the end of this article.) 15 In these twostudies, the CECT system was used on in-hospital total hip arthrocontinuedon page 3332 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

FUTURETECHcontinued from page 32plasty (THA) and total knee arthroplasty (TKA) patients.The third study was designed to also include the moredemanding outpatient environment, in which patients’ mobility isgradually increasing and professional assistance is limited. In thisstudy, the ActiveCare+SFT device was compared with LMWH in aprospective randomized clinical trial that took place in nine leadingU.S. medical centers (the S.A.F.E. study, standing for SFTAlternative For Enoxaparin). The study was done on 414 patientswho underwent THA and its endpoints were VTE and bleeding.This is the first and only study so far comparing a device to LMWHthat carried both treatment arms through the recommended tendays of treatment (in-hospital + out of hospital treatment). Studyresults demonstrated that the new CECT device is as effective as thepotent anticoagulant in preventing VTE, but with significantly lessbleeding complications. (See summary at the end of this article.) 16Based on these results, the medical centers that participated inthe study have switched to using the ActiveCare+SFT as a standalone agent for DVT prevention, according to the study protocol.Summary of Relevant Clinical PapersCECT + LMWH vs. IPC + LMWH 12Objective: This non-randomized (sequential), comparative,performance study was designed to compare the efficacy of theCECT system with that of a standard IPC device for VTEprophylaxis.Design: 1,577 THA and TKA patients were available for perprotocol analysis:During the first 12 months of the study, 1,354 patients weretreated with combination of standard IPC+LMWH. In thefollowing three months, 223 patients used CECT+LMWH.Bilateral duplex scan was performed before discharge.Results: The replacement of the standard IPC by the CECTsystem significantly reduced the VTE rate (70 percent RelativeRisk Reduction, P< 0.05). The average hospital LOS was shorterfor patients in the CECT group (4.2 days vs. five days). Patients’compliance was significantly higher for the mobile CECT systemthan for the IPC (83 percent vs. 49 percent).Conclusion: The portable CECT system proved significantlymore effective than the standard IPC when used in conjunctionwith low-molecular-weight heparin for DVT prevention in highriskorthopaedic patients. Exhibit 2 provides a visual representationof results.CECT vs. LMWH (in-hospital prophylaxis) 15Objective: This prospective, randomized, comparative studywas designed to evaluate the efficacy of the CECT protocol incomparison with standard LMWH protocol for VTE prophylaxisin in-hospital patients.Design: 121 THA and TKA patients were prospectively randomizedinto two treatment groups: 61 patients were treated withCECT system starting immediately after the induction ofanesthesia; 12 hours after surgery 100 mg aspirin per day wasadded. The 60 control group patients received 40 mg enoxaparinper day, starting 12 hours after surgery. Bilateral venographywas performed before discharge.Results: In the CECT group, as compared with the enoxaparingroup, there was a significantly lower overall rate of DVT (77pecent Relative Risk Reduction, p=0.002) and a lower rate ofproximal DVT (84 percent Relative Risk Reduction, p=0.049).Multivariate analysis for prediction of DVT incidence revealedsignificant superiority of the new CECT protocol overenoxaparin protocol (Odds Ratio 6.5, p=0.002).Conclusions: The CECT based protocol proved significantlymore effective than LMWH for DVT prevention in high-riskorthopaedic inpatients. Exhibit 3 provides a visual representationof results.Exhibit 3: Summary of CECT vs. LMWHExhibit 2: Summary of CECT vs. IPCcontinued on page 34November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 33

FUTURETECHcontinued from page 33ActiveCare+SFT vs. LMWH (in-hospital and out of hospitalprophylaxis) 16Objective: This prospective, randomized, multicenter study wasdesigned to evaluate the safety and effectiveness of the CECTsystem with LMWH for VTE prevention after total hip arthroplasty.Design: 414 THA patients were prospectively randomized intotwo treatment groups, and 397 were available for per-protocolanalysis: 199 patients received the CECT system startingimmediately after the induction of anesthesia. Twelve hoursafter surgery, 81 mg aspirin per day could be added (accordingto the surgeon’s preference). The 198 control group patientsreceived LMWH 30 mg twice daily until discharge and 40 mgdaily after discharge. First LMWH injection was given 12-24hours post surgery. Both groups were treated for ten postoperativedays. Bilateral duplex scans were performed after the end oftreatment.Results: There was no statistical difference between the groupsin the incidence of venous thromboembolism. DVT occurred infour percent in the CECT group and 4.1 percent in the LMWHgroup. PE incidence was one percent in each of the treatmentgroups. The major bleeding rate was zero percent for the CECTgroup and 5.6 percent for the LMWH group (p

Gaps in ClinicalEvidence: The Casefor Better DataFUTURETECHAuthors: Scott Lovald, Ph.D., M.B.A., M.E.; Keith KennedyAs far as successful orthopaedic ventures go, few are as remarkableas the story of Kyphon. After releasing its first product,Kyphon grew its annual sales from $261,000 in 1999 to more than$400 million in 2006. 1 While the company’s success certainlyresulted from skilled leadership and a large, rapidly expandingmarketplace, Kyphon also set itself apart by working withleading surgeons to prove the clinical benefits of its flagshipproducts used in balloon kyphoplasty procedures. While theirfindings had been presented at earlier conferences, the firstpublished clinical evidence on kyphoplasty came in 2001, 2 andthe first papers on randomized trials came in 2004 and 2005. 3, 4Not surprisingly, as positive clinical results were reportedpublicly, the company’s revenuescontinued to skyrocket. The Kyphonaccount provides a great example ofhow a small orthopaedic start-upcan find success by demonstratingthe real-world results of its innovation.A company that supports clinicalresearch gains the ability to create aforum for potentially differentiatingnew products and procedures.Subsequently, this forum creates anopportunity to initiate and buildrelationships with top surgeons.Despite these advantages, manycompanies will support studies thatinvestigate only biomechanical test data on their products,sometimes going little further than meeting regulatory requirements.In most cases, engineering the widespread marketadoption of any new product or procedure requires clinicalevidence. In orthopaedics, this proof typically comes in the formof a post-market clinical trial, the gold standard of which is aprospective, long-term randomized clinical trial.Significant clinical benefits are often derived from seeminglyincremental product changes in established orthopaedicmarkets. Some examples include the clinical effects of moreprecise tolerances and improved bearing materials on reducingosteolysis in hip arthroplasty, or the reduced soft tissue irritationrealized through the introduction of fixed angle volar plating to“Medical device entrepreneurscan give themselvesa significant marketadvantage by supportinghigh-quality post-marketclinical research for theirmost innovative productsand procedures.”treat distal radius fractures. Given the number and frequency ofproduct and procedure modifications that occur in orthopaedics,there is typically a strong possibility that a clinically beneficialnew product in a controversial area is already approved.The following analysis reviews newer arthroplasty and otherorthopaedic technology trends that have generated someinterest, but have not seen clear positive results with that firstdifference-making device. Each section further detailsframeworks for the high quality post-market trials that couldprovide the necessary exposure to clinically differentiate a newinnovation.Hip ResurfacingBy 2020, the number of primarytotal hip arthroplasty (THA)procedures is expected to be justshy of 400,000. 5 This treatmentpresents both an enormous andgrowing cost to the healthcaresystem as well as an opportunity forentrepreneurs. Although THA hasprovided generally good outcomesfor elderly patients, device survivalrates of ten years for men youngerthan 55 are only 80 percent. 6Likewise, for patients under 60, asingle hip replacement rarely lastsfor the patient’s entire lifetime. 7 Analternative treatment, hip resurfacing, removes only the arthriticsurface of the joint and conserves far more bone stock than atraditional THA. Clinicians report advantages of using thistreatment in younger, more active patients because any eventualrevision benefits from the preserved bone stock. Additionaltheoretical benefits of hip resurfacing include less stressshielding, less pain, fewer dislocations, reduced osteolysis andimproved biomechanics and clinical function. 8 Despite theproposed advantages, no system has yet been shown to providea clinically meaningful difference. Some studies have evenreported higher revision rates, often associated with femoral neckcontinued on page 3736 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

FUTURETECHcontinued from page 36fractures, 9 although many studies also show that this ratedecreases with clinical experience.A recent review of hip resurfacing literature revealed that of207 studies, none was considered of the highest quality standardfor clinical trials. 8 Until better evidence is available, there remainsa high risk in some patients for poor performance and highercosts stemming from unnecessary complications, poor survivorshipand early required revisions. It is understood that thecurrently available clinical outcomes may be more representativeof the specific resurfacing systems in use and not of the hipresurfacing concept in general. There are now only two productscleared for use in the U.S., and there are no documented differencesof clinical outcome from diverse surgical approaches. 9A randomized control trial comparing THA and hipresurfacing procedures for different age groups would be anenormous benefit to patients, physicians and the industry as awhole. Collected outcomes would include complications,survivorship, quality of life (SF-36, SF-12), pain, satisfaction,functionality (Harris Hip Score, WOMAC) and radiographs.Short- and medium-term results could be published intermittentlyto report any differences in pain, satisfaction andfunctional outcomes. The study should also include a revisionsurgical summary in the cases where the resurfacing implant isconverted to a standard arthroplasty. This surgical data wouldmeasure parameters related to the ease of conversion. Lastly, thestudy should include means to measure metal ion exposureassociated with metal on metal bearings. Table 1 provides aproposed data collection grid for this type of study.Computer-Assisted, Minimally Invasive Knee ArthroplastyIt is expected that there will be over 1.5 million primary totalknee arthroplasty (TKA) procedures in the U.S. by 2020. 5 Bothminimally invasive and computer-assisted minimally invasiveknee arthroplasty offer potential beneficial effects over traditionalTKA. Minimally invasive surgery (MIS) aims to minimize theincision length, minimize morbidity and strain to the quadriceps,and avoid patella eversion. Some studies have reported lessimmediate post-operative pain, earlier function, shorter hospitalstays and better cosmetic appearance, while other studies haveshown an increased rate of complications such as malpositioningof the hardware. 10 Still others suggest that MIS increasesoperating time. 11 Despite numerous studies and promotionefforts, “there are no significant objective data suggesting MISTKA offers superior long-term results.” 10Many medical device companies continue to work toward realinnovation in this area by decreasing the size of the instrumentationfor minimally invasive surgical technique. Other innovationshave included the use of computer-assisted surgery (CAS). CASutilizes navigational markers to improve visualization andradiographic limb alignment, 10 and some speculate that betteralignment will increase the survival of the implants. The reemergenceof unicompartmental knee arthroplasty (UKA)represents another possible avenue. Despite interest, there are norandomized controlled trials to confirm any patient benefit ofMIS for UKA. 12 MIS, CAS and UKA are all associated with a steeplearning curve, 10, 12 making the procedures a tough sell when thebest available evidence suggests that outcomes are only as goodas TKA.A groundbreaking study on MIS, CAS and their use inconjunction with UKA would include prospective, randomizedenrollment and follow-up after two, five and ten years. While tenyears is longer than a typical business start-up lifespan, havingthe mechanisms in place to collect long-term outcomes is beneficial,especially if short- and mid-term data are promising.Collected outcomes would include complications, survivorship,quality of life (SF-36, SF-12), pain, satisfaction, functionality(Knee Society Scores, WOMAC), radiographic alignment, time insurgery and total cost. Short- and medium-term results could bepublished intermittently to report any differences in pain,satisfaction, functional outcomes and implant migration. Thestudy should be conducted across a number of centers bysurgeons with established experience in these procedures. Table 2on the following page shows a potential data collection grid forthis type of study.Table 1: Data collection grid for hip resurfacing studycontinued on page 38November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 37

FUTURETECHcontinued from page 37Table 2: Data collection grid for knee arthroplasty studyRotator Cuff RepairCurrent controversies are by no means confined to arthroplasty.Rotator cuff repair is also a rapidly growing, rapidlychanging procedure that is the subject of opposing viewpointsarmed with little clinical evidence. Rotator cuff tears are the mostcommon source of shoulder pain and disability 13 and rotator cuffsurgery is intended to alleviate pain and improve shoulderfunction in the wake of these tears. Over the years, the surgeryhas evolved from open procedures, mini-open proceduresassisted by arthroscopy and full arthroscopic procedures. Mostrecently, a controversy has developed around the clinical benefitsof arthroscopically assisted mini-open procedures vs. full arthroscopicprocedures.The mini-open technique uses a four to six centimeter incisionand a unique set of arthroscopic-assisted instruments to performthe repair. The relative benefit of using this procedure instead ofthe full arthroscopic technique is that it allows for bettertransosseous fixation and footprint restoration. This enables theapplication of stronger, modified stitching techniques, such as theMason-Allen stitch. The disadvantages of this technique includereports of increased stiffness, less range of motion, higherinfection risk and increased prevalence of arthrofibrosis. 14 The fullarthroscopic technique uses a fiber optic scope and pencil-sizedinstruments inserted through a small incision. This minimallyinvasive procedure is reportedly associated with less pain, rapidrehabilitation, smaller incisions, less soft tissue dissection andlow risk of deltoid detachment. 14 In some cases, there can also bebetter three-dimensional visualization. Full arthroscopic cufffixation is obtained with suture anchors, which are reported tohave weaker fixation strength than transosseous tunnels. Also,the procedure is technically demanding, and typically onlyavailable at high-volume practices. 14Nho et al. 14 stated that there is a “need for an improvement inquality in published studies on rotator cuff repair.” Two recentmeta-analyses found only Level III retrospective case controlstudies, 14,15 and were unable to discern a clinical differencebetween the two methods. Other aspects of the surgery have notbeen fully evaluated using clinical outcomes. For example, moststudies of arthroscopic outcomes have used single-row anchorfixationconfiguration, while a double-row version has beenshown to better replicate the native footprint. 15 Lastly, the clinicaleffect of footprint restoration is not yet fully understood. 15Ideally, a multi-center randomized control trial would includevalidated outcomes scores and post-operative imaging. Collectedoutcomes would include complications, range of motion, pain,patient and surgeon satisfaction, quality of life (SF-36, SF-12),functioning (American Shoulder and Elbow Surgeons, DisabilityArm Shoulder Hand Score, Western Ontario Rotator Cuff) andpost-operative radiographs. The current lack of post-operativeradiographic assessment leaves a gap of understanding on theradiographic integrity of any repair. An appropriate time framefor the study would be from two to five years, in order to assesslonger term follow-up. Participating centers should have significantexperience with both procedures. As outcomes have beenreported to be highly dependent on the pre-operative tear size, 16this variable should be measured and controlled. Table 3 shows apotential data collection grid for this type of study.ConclusionLike Kyphon, medical device entrepreneurs can givethemselves a significant market advantage by supporting highqualitypost-market clinical research for their most innovativeproducts and procedures. Ironically, there is a dearth of suchstudies in the largest, fastest growing orthopaedic markets,despite controversies surrounding a number of emergingtechnologies. These controversies provide an opportunity forentrepreneurs to show the worth of their innovations throughcontinued on page 3938 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

FUTURETECHcontinued from page 38Table 3: Data collection grid for rotator cuff repair studyhigh-quality randomized post-market trials while cementingstrong relationships with forward thinking, like-mindedsurgeons.While this article discusses the gap in high quality clinicalresearch in just a few markets, this distressing trend is notisolated to hip resurfacing, minimally invasive knee arthroplastyand rotator cuff repair. For example, a recent systematic review ofthe literature reporting outcomes of total ankle arthroplastyfound only Level IV evidence studies. 17 Until use of high-qualitytrials for new products becomes standard practice, skepticismamong clinicians will persist and market adoption of new ideaswill be slow.References1. “Globus Breaks Sales Performance Record: $0 to >$80MM in Less than 3 1/2Years,” ORTHOKNOW®, February 2007, pp. 4.2. Lieberman, I.H., Dudeney, S., Reinhardt, M.-K., Bell, G., 2001, “Initial outcomeand efficacy of ‘Kyphoplasty’ in the treatment of painful osteoporotic vertebralcompression fractures,” Spine, 26: 1631-1638.3. Ohlin, A., Johnell, O., 2004, “Vertebroplasty and kyphoplasty in the fracturedosteoporotic spine,” Clin Calcium, 14: 65-69.4. Grafe, I.A., Da Fonseca, K., Hillmeier, J., Meeder, P.J., Libicher, M., Noldge, G.,Bardenheuer, H., Pyerin, W., Basler, L., Weiss, C., Taylor, R.S., Nawroth, P.,Kasperk, C., 2005, “Reduction of pain and fracture incidence afterkyphoplasty: 1-year outcomes of a prospective controlled trial of patients withprimary osteoporosis,” Ostoporosis Int, 16: 2005-2012.5. Kurtz, S., Ong, K., Lau, E., Mowat, F., Halpern, M., 2007, “Projections ofprimary and revision hip and knee arthroplasty in the United States from 2005to 2030,” J Bone Joint Surg Am, 89:780-785.6. Grigoris, P., Roberts, P., Panousis, K., Bosch, H., 2005, “The evolution of hipresurfacing arthroplasty,” Orthop Clin N Am, 36: 125-134.7. McGrath, M.S., Desser, D.R., Ulrich, S.D., Seyler, T.M., Marker, D.R., Mont,M.A., 2008, “Total hip resurfacing in patients who are sixty years of age orolder,” J Bone Joint Surg Am, 90: 27-31.8. Nunley, R.M., Della Valle, C.J., Barrack, R.L., 2009, “Is patient selectionimportant for hip resurfacing?” Clin Orthop Relat Res, 467: 56-65.9. Huo, M.H., Parvizi, J., Bal, B.S., Mont, M.A., 2008, “What’s new in total hiparthroplasty,” J Bone Joint Surg Am, 90: 2043-2055.10. Ulrich, S.D., Mont, M.A., Bonutti, P.M., Seyler, T.M., Marker, D.R., Jones, L.C.,2007, “Scientific evidence supporting computer-assisted surgery andminimally invasive surgery for total knee arthroplasty,” Exp Rev Med Dev, 4:497-505.11. Dutton, A.Q., Yeo, S., Yang, K., Lo, N., Chia, K., Chong, H., 2008,“Computer-assisted minimally invasive total knee arthroplasty comparedwith standard total knee arthroplasty. A prospective, randomized study.” JBone Joint Surg Am, 90: 2-9.12. Borus, T., Thornhill, T., 2008, “Unicompartmental knee arthroplasty,” J AmAcad Orthop Surg, 16: 9-18.13. MacDermaid, J.C., Holtby, R., Razmjou, H., Bryant D., JOINTS Canada, 2006,“All-arthroscopic versus mini-open repair of small or moderate-sized rotatorcuff tears: a protocol for a randomized trial [NCT00128076],” BMCMusculoskelet Disord, 7: 25.14. Nho, S.J., Shindle, M.K., Sherman, S.L., Freedman, K.B., Lyman, S.,MacGillivray, J.D., 2007, “Systematic Review of Arthroscopic Rotator CuffRepair and Mini-Open Rotator Cuff Repair,” J Bone Joint Surg Am, 89: 127-136.15. Morse, K., Davis, A.D., Afra, R., Kaye, E.K., Schepsis, A., Voloshin, I., 2008,“Arthroscopic Versus Mini-open Rotator Cuff Repair,” Am J Sports Med, 36:1824-1828.16. Kim, S., Ha, K., Park, J., Kang, J., Oh, S., Oh, I., 2003, “Arthroscopic VersusMini-Open Salvage Repair of the Rotator Cuff Tear: Outcome Analysis at 2 to6 Years’ Follow-up,” Arthroscopy, 19: 746-754.17. Gougoulias, N., Khanna, A., Maffuli, N., 2009, “How Successful are CurrentAnkle Replacements,” Clin Orthop Relat Res, Epub.Scott T. Lovald is a Clinical Project Manager with PhDx SystemsInc., a leading provider of post market clinical data managementsolutions for the cardiovascular, orthopaedic and spine researchcommunities. He is also a founder of Satyrne Medical, a smallcompany focused on minimally invasive internal fixation concepts forthe trauma market. He can be reached at 505-620-3856 or atslovald@phdx.com.Keith D. Kennedy is the Vice President of Sales and Marketing forPhDx Systems Inc., a leading provider of post market clinical datamanagement solutions for the cardiovascular, orthopaedic and spineresearch communities. Mr. Kennedy previously worked for Schering-Plough, a Fortune 500 pharmaceutical company, as well as a majorIndependent Review Board where he served on the ExecutiveLeadership Team. He can be reached at kkennedy@phdx.com.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 39

FUTURETECHStandardized RadiographicDigital Imaging: A Cost EffectiveAlternative to CT and MRIAuthor: T. Derek V. Cooke, M.B., B.Chir., F.R.C.S.C.The advent of digital imaging has enhanced convenience andlowered costs of radiography, and the technology is rapidlybecoming universal.Two options currently exist. Computed radiography (CR) usesan imaging plate (phosphor-based) in place of film, which isscanned by laser to digitize the image. It has the advantages ofhigh sensitivity and resolution, with exposure compensation tomaximize contrast. Digital radiography (DR) employs a variety ofimaging plates with similar advantages to CR, but the image isinstantaneously captured digitally and displayed on a computermonitor. A central feature of both CR and DR is that they arereadily integrated into Picture Archiving Computer Systems(PACS) which manage image storage and retrieval.Despite its advantages (logistics, image sharpness, contrast,magnification, computerised metrics, etc.), digital image capturedoes not automatically provide a more reliable radiograph thantraditional methods. Imprecision may arise from other sources suchas poor positioning of the patient and image distortion due toparallax. 1 Standardized Imaging is a concept designed to limit, orcorrect for, these sources of error. It is applicable to CR, DR or filmbasedmethods. An example of such a method is Standardized KneeImaging (SKI) 2,3 in which each patient is set up in a standardizedposition within a frame (See Exhibit 1), which also inserts one ormore registration grids into the x-ray field.The grid image(s) are superimposed on to the target image, andthe combined image is processed digitally to correct for any parallaxerror. Using SKI we can expect reproducibility of angular measurementsto be within ± 1.5° and dimensional measures within 1.4mm. 3This leads to better clinical evaluations. 3-6 For example, Exhibit 2shows the results of a re-alignment osteotomy, and Exhibit 3 showshow the change in limb alignment can reflect focal attrition of plasticin a total knee arthroplasty, which may occur prior to the onset ofsymptoms. 7 Likewise, in knee osteoarthritis (in which deteriorationof the joints has been correlated with alignment change), progressionof the disease may be monitored by Standardized Imaging. 7 Also, inthe clinic, the method offers standardized metric imaging forpreoperative sizing of implants of all types.In research, SKI has proved to be an invaluable measurementtool, for example in population studies of varus- and valgus-alignedosteoarthritis (OA). 8,9 When readers are appropriately trained, interandintra-reliability parameters are high. The principles ofStandardized Imaging, encompassing both control of positioning andmeans to correct for parallax, have been applied in major studiessupported by the National Institutes of Health, such as theMulticentre Osteoarthritis Study 10 and the Osteoarthritis Initiative. 11Priorities in the further development of Standardized Imaging arethe development of easily applied positional units with suitablemarkers to be used for image correction. Further, the capability forstandardized metric imaging is obviously relevant to surgicalplanning via manipulative software, and there is room for developmenthere. In many cases, this approach will circumvent the need formore costly procedures like computed tomography and magneticresonance imaging.Exhibit 1: SKI frame with turntable to position patient. Registration gridis mounted to the frame. Turntable is rotated for frontal and orthogonalviews.continued on page 4140 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

FUTURETECHcontinued from page 40Exhibit 2: SKI radiographs and digital analysis (frontal plane) of realignment osteotomy to right leg. Note the change of Hip-Knee-Ankle (HKA)angle from varus –13.5° to valgus +3°. The dots shown on the images are the registration markers used for parallax correction.Exhibit 3: SKI radiograph and analysis (frontal plane) of failed Rt. TKAmedial collapse. The progressive change in HKA (now at -21°) indicatesbearing wear.5. Cooke TDV, Price N, Fischer B, Hedden D. The inwardly pointing knee. Anunrecognized problem of external rotational mal-alignment.Clin Orthop 260:56-60, 1990.6. Harrison MM, Cooke TDV, Fisher SB, Griffin MP. Patterns of knee arthrosis andpatellar subluxation. Clin Orthop 309:56-63, 1994.7. Cornwall GB, Bryant JT, Hansson CM, Rudan J, Kennedy LA, Cooke TDV. Aquantitative technique for reporting the surface degradation of UHMWPEcomponents of retrieved total knee replacement. J Appl Biomater 6:9-18, 1995.8. Cooke TDV, Kelly BP, Harrison L, Mohamed G, Khan B. Radiographic gradingfor knee osteoarthritis: a revised scheme that relates to alignment anddeformity. J Rheumatol 26:641-644, 1999.9. Cooke TDV, Harrison L, Khan B, Scudamore RA, Chaudhary MA. Analysis oflimb alignment in the pathogenesis of osteoarthritis: a comparison of SaudiArabian and Canadian cases. Rheumatol Int 22:160-164, 2002.10. www.researchresources.bumc.bu.edu/abstract/5U01AG018820-06.htm11. www.niams.nih.gov/Funding/Funded_Research/Osteoarthritis_Initiative/default.aspNote: SKI or Standardized Knee Imaging describes the proprietarytechniques developed by OAISYS Inc. to obtain Metric Images of the lowerlimb and their analysis. Please see www.oaisysmedical.com for details.References1. Cooke TDV, Sled EA. Optimizing limb position for measuring knee anatomicalaxis alignment from standing knee radiographs. J Rheumatol 36:472-477, 2009.2. Cooke, TDV, Sorbie C, Scudamore RA, Bryant JT, Siu D, Fisher B. A quantitativeapproach to radiography of the lower limb. J Bone Joint Surg 73B:715-720, 1991.3. Siu D, Cooke TDV, Broekhoven LD, Lam M, Fisher B, Saunders G, Challis TW.A standardized technique for lower limb radiography. Practice, applications,and error analysis. Invest Radiol 26:71-77, 1991.4. Cooke TDV, Pichora D, Siu D, Scudamore RA, Bryant JT. Surgical implicationsof varus deformity of the knee with obliquity of joint surfaces. J Bone Joint Surg71B(4):560-565, 1989.Dr. Cooke was educated at Cambridge University and St. Bartholomew'sHospital in England. He became a full professor of surgery at Queen's in1984. In 1992, Dr. Cooke took the Chair of the Orthopedic Department atKing Faisal Specialist Hospital and Research Center in Riyadh, where, forthe next five years, he continued his work in reconstructive surgery,arthritis and imaging research.In 1996, Dr. Cooke established OAISYS Inc. as the means to bring relevantdevelopments in research to the clinician to solve clinical problems. Thiswork extended into the field of digital image analysis with programs andhardware applications that focus on musculo-skeletal solutions.Dr. Cooke is co-holder of 12 patents and has published over 110 peerreviewedmanuscripts. He can be reached at tdvcooke@oaisysmedical.com.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 41

FUTURETECH UPDATEThe Potential for RepairingMeniscal White Zone TearsAuthor: Randall Holcomb, M.D.In the July/August 2006 issue of ORTHOPAEDIC PRODUCTNEWS, we featured an article about technology for the repair ofavascular meniscus tissue. Since that time, the technology has beenreleased to clinical use under a 510(k). The following serves as anupdate.In the past 75 years, the knee joint meniscus has transitionedfrom a poorly understood “vestigial remnant” to becoming thestructural cornerstone of the knee. Indeed, in 1897, Suttondescribed the meniscus as “functionless remains” of the legmuscle, although twelve years earlier in 1885, ThomasAnnandele described the first surgical meniscal repair. Inensuing years, the knee joint meniscus was relegated toobscurity until 1936, when King published his work on meniscusrepair in dogs.Twelve years later, in 1948, Fairbank published his landmarkwork on the disappointing outcome of total meniscal removaland subsequent degenerative changes seen radiographically. Foranother 30 years, very little change occurred in treating meniscalinjury. Extirpation was the mainstay of surgical treatment. In the1970s and early 1980s, a veritable meniscal renaissance occurred.Major scientific inroads in understanding meniscal biology andbiomechanics appeared in peer reviewed literature. Contributorssuch as Arnozky and Henning spoke of actual treatments formeniscal injury, instead of extraction.In the 1980s, it would be virtually impossible to attend asports medicine conference or knee symposium without hearingnumerous variations on the meniscus repair theme. Dehaven,Cannon and many others wrote of repair techniques withvarious descriptors such as “inside out,” “outside in,” and “allinside,” indicating the surgical approach. Despite their technicaldifferences, each had one common purpose: repair of the kneejoint meniscus.The past ten years have yielded many excellent reviews ofmeniscal repair concepts, details of which are beyond the scopeof this article. They share a common and somewhat disturbingfinding. The “success” of meniscal repair varies from 50 to 75percent. As is so often the case, the “devil is in the details” ofoutcomes reporting. One can interpret success in many ways,but the elephant in the room is that incomplete rim healing wascommon. Even though some patients were asymptomatic orminimally symptomatic, healing defects were frequentlypresent.Some authors reported revision rates of 20 percent or moreand healing failure rates of 36 percent. Prognostic factors weredescribed as both positive and negative. The positive factorsinclude anterior cruciate ligament injury, acute repair, rim widthless than three millimeters and tears involving the lateralmeniscus. Negative factors reported were residual ligamentinstability, pink and white zone tears, and older age.The answer to this clinical conundrum may lie in themeniscus vascularity. In 1936, King and co-workers firstdescribed the sequence of events in meniscal healing. Since then,numerous experimental observations have demonstrated theability of the peripheral blood supply of the meniscus to providea reparative response to injury.A fibrin clot forms that is rich in inflammatory cells. Next inthe healing sequence, comes the invasion of the scaffold byadjacent blood vessels from the synovium. This is accompaniedby proliferation of undifferentiated mesenchymal cells. Withtime, the tear is filled with fibrovascular tissue that becomescontiguous with adjacent meniscal tissue. This scar eventuallymatures into normal-appearing fibrocartilage in several months.Thus, even to the casual observer, it becomes apparent there isno vascular supply, and no repair sequence. It appears that the“Holy Grail” of meniscal healing may be linked to the extent orpattern of tear vascularity.While meniscal repair is generally limited to the red/red orred/white zone, experimental techniques have shown the abilityfor white/white lesions to heal. For years, investigators havestudied the potential for healing via vascular access channels.continued on page 4342 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

FUTURETECH UPDATEcontinued from page 42Warren and Arnozky, Henning and others demonstrated theability to create vascular channels. These channels would facilitatevascular invasion of an otherwise avascular area.Unfortunately, it was shown experimentally, the vascularconduit concept was only functional with limb immobilizationand non-weightbearing status.Several years ago, a group of surgeons began discussions inmodification of a concept proposed by Herbert Schwartz, abiomedical engineer. Schwartz had been involved in meniscalresearch and became interested in Henning’s work concerningvascular access channels. Out of this work, a “biological duct”was born to facilitate vascular channeling without the need forimmobilization and non-weightbearing status in the postoperativeperiod. Early animal studies demonstrated proof of concept.A brisk meniscal repair response and infill was seen in whitezone meniscal defect in animals treated with the BioDuct®device. The white zone meniscal defects remained unfilled incontrol animals. The BioDuct device is made of bioabsorbablePoly-L Lactic Acid. The implantation of the device is achievedarthroscopically into the tear margin utilizing a Nitinol wireguide. BioDuct is amenable to use with both “inside out” and“all inside” repair techniques.The potential for the BioDuct in the future may include tearsheretofore deemed irreparable. This may include complexcomminuted tears that today undergo resection. If vascularitycan be adequately channeled, white zone tears may be reparablein the future. BioDuct has received FDA 510(k) clearance as afixation device for longitudinal vertical meniscus (buckethandle) tears in the red/white zone when used with sutures.Dr. Holcomb is the Chief Executive Officer of OrthoMemphis and afellow of the American Academy of Orthopaedic Surgeons,Arthroscopy Association of North America, American OrthopaedicSociety for Sports Medicine, International Society of Arthroscopy,Knee Surgery, and Orthopaedic Sports Medicine. Interested partiesmay contact Dr. Holcomb via his assistant, Suzanne Shankle, atsshankle@orthomemphis.com.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 43

VIEWS ON THE NEWSIn this feature, we will highlight recent news or trends thatmight significantly impact your future as orthopaedic surgeons.We’ll print your views in subsequent issues.Below is a portion of a recent article describing something we are hearing more and moreabout. How will this be reconciled with the healthcare reforms currently under debate?As part of healthcare reform, different groups within the U.S. healthcare industry haveeither promised concessions to help reduce healthcare costs or are being targeted for feesthat will contribute to the financing of healthcare moving forward. For example,1) The hospital industry agreed to cut $155 billion in government costs overthe next ten years.2) The insurance industry agreed to remove preexisting condition limitationsfrom policies. Insurers would be assessed $6.7 billion in fees per yearfor ten years, based on their U.S. market shares.3) Pharmaceutical companies promised to spend more than $100 million toadvertise for reform and promised $80 billion in cost reductions over theten year period. In addition, as an industry they would be assessed a $2.3billion fee per year based on their market shares in the U.S.4) Medical device companies would pay $4 billion in fees per year based ontheir market shares in the U.S. (Those with sales below $5 million wouldpay nothing.)What do you think?Email your thoughts to usopn@orthoworld.com.46 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

PRODUCT FEATURESHip & Knee SurgeryThe Tradition Hip SystemThe BioPro® Tradition Hip carries on CharlesTownley, M.D.’s Horizontal PlatformSupport design philosophy.The implant is designedto be physiologicallystress loaded and incorporatesa platform perpendicularto theresultant forces ofbody weight and muscleforces. The design isintended to eliminateadaptive bone remodelingand stress shielding,which is a known causeof bone loss followingjoint replacement. Thetime tested designcomes in porous coatedand non-porouscoated versions in three differentlengths and thirteen sizes.The extra-short stem, or the LivingHip, is an ultra-short femoral stem availablein nine sizes with a minimal increase inlength, ranging from 95 mm to 115 mm in length. Due to the shortlength, the stem does not extend into or beyond the natural anteriorbow of the femur. This allows for increased proximal fill withresultant increased stability proximally.The ultra-short stem helps address the issue of thigh pain. Theelasticity of bone is greater than that of metal. If a stem extendsinto the anterior bow, the femur bends around the implant, causingirritation and pain. The Living Hip is proximal to the area ofthe bend, causing minimal irritation to the femur.BioProTel: 800-252-7707www.bioproimplants.com/hips.phpVascuTherm Iceless ColdTherapy, Compression and DVTProphylaxis TherapyThe VascuTherm by ThermoTek delivers a unique and proprietarythermal compression therapy solution in one easily transportabledevice. Its solid-state technology eliminates the need forice, offers precise temperature control for preventing thermal tissuedamage, and delivers exceptional reliability. VascuThermoffers highly effective DVT prophylaxis through its programmablemultiple treatment modalities, combining heating/coolingtemperature management with vascular compression and isMedicare HCPCS listed.Treatment Modalities: Compression Therapy • DVT Prophylaxis• Cold Therapy • Heat Therapy • Contrast TherapyIndications: Edema • Lymphedema • Arterial Insufficiency •PainThermoTek, Inc.Tel: 972-874-4949www.thermotekusa.comAlternative Surface Technology for Knee ImplantsAesculap Implant Systems markets Alternative Surface (AS) Technology, an advanced coating system forknee implants that offers a surface with advantages over Cobalt Chrome (CoCr). The coating, whichreportedly produces less wear and releases significantly fewer metal ions than CoCr, will be applied toAesculap's Columbus knee.The seven-layer coating is composed primarily of Zirconium Nitride, a durable ceramic material thatcreates a harder and more durable surface than traditional implant materials. In ISO wear testing, the surfacehas shown wear rates of just 3.5 mg/million cycles. ISO-certified laboratory testing also indicated thatthe release of Ni ions has been significantly reduced. Additionally, the design of the seven-layer coatingaids in the prevention of mechanical ablation, a separation of the coating from the substrate, which may bea shortcoming of some mono-layer coatings.The Columbus knee system features a full portfolio of AS-coated components, including Femur and Tibiacomponents as well as Tibial Augments and Stems.Aesculap Implant Systems, Inc.Tel: 866-229-3002www.aesculapimplantsystems.comNovember/December 2009 • ORTHOPAEDIC PRODUCT NEWS 47

PRACTICE MANAGEMENT SOLUTIONSThe #1 Physician FinancialMistake: Part OneAuthors: Lori Adasiewicz, Esq., David B. Mandell, J.D., M.B.A., and Jason M. O’DellAs authors of financial and legal books for doctors and as attorneyswith numerous physician clients, we have collectively consultedwith thousands of doctors of all specialties during the last decade.From this experience, we have become intimately familiar with themistakes physicians make when working with CPAs, attorneys andother financial advisors. Whether relative to tax, asset protection,retirement planning or other areas, the result is almost always thesame. We leave the meetings or conference calls asking ourselves,“How could this doctor get such (poor/uncreative/just plainwrong) advice?” It would be laughable if it weren’t so troubling.It is not surprising that physicians do not get the value theyshould out of their professional advisors. While the typical specialtyphysician has nearly 25,000 hours of training in his profession, hehas zero hours of training in related to the “business” of being adoctor. After learning how to utilize specialists in other areas ofmedicine, doctors receive no training in how to evaluate or choosethe advisors whose advice and experience will be the backbone oftheir financial plans for their entire careers.Doctors lack the spare time and training to do their own planningand have no guidance on how to find and evaluate the rightspecialists to assist them, so it is no wonder that most are ill-servedby their professional advisors. To be honest, it is surprising whenwe meet a physician who is financially savvy or is properly advisedby a team of professional advisors. In our experience, fewer than fivepercent of physicians are properly advised by a professional team.In this first of a two-part article, we will point out two fatal flawsthat we see in physician/advisor relationships. In part two, we willcontinue to explain how to remedy these problems so you can movetoward your goals of minimum lawsuit and tax exposure and maximumpiece of mind.Fatal Flaw #1: How Physicians Choose AdvisorsThe first mistake made by the overwhelming majority of physiciansin the financial, legal or tax aspect of their careers is how theychoose a professional advisor. Whether it be a CPA, investment professionalor attorney, many physicians use a flawed method inselecting the advisor, resulting in a suboptimal choice.When you consider the typical pattern, this is not surprising.Most doctors choose their advisors when they are in residency orfellowship, as this is the time when most doctors begin to makemoney or start a family. The doctors may need some insurance, awill and someone to prepare tax returns. Doctors typically do whatother busy people do and take the path of least resistance (and minimumtime commitment). They use the advisor the older residentsuse, find someone recommended by the local medical society orhire a friend or family member.Though this unscientific approach is flawed, it serves its purposewhen bigger challenges are at hand (like 20 hour work days, graduationand finding a job). Your life is hectic, you just need to “get itdone fast.” The advisor you choose at this point simply has to bedecent and cheap—and that is good enough. Like a triage nurse inan emergency room, a top-trained specialist is unnecessary whenall you need are a few basic stitches.What is alarming to us is not this initial choice of advisor, but,rather, the fact that most physicians stay with these same advisors for therest of their careers. The typical justification for this is rarely anythingconcrete or acceptable. Doctors give us explanations like, “We havebeen together so long, I’d hate to change now,” or “If it ain’t broke,don’t fix it.” However, how do you know “it ain’t broke” if youdon’t get a second opinion?Most alarming (and common) is when a physician stays with anadvisor when the doctor has clearly outgrown the advisor’s expertise.Consider the following real-life example:Case Study: Oscar the Orthopaedic SurgeonOscar, a Nevada orthopaedic surgeon, was an owner in anextremely successful practice and made over $1 million peryear. He used the same New York-based lawyer he’d retained tocreate his wills ten years earlier when he was a resident.This attorney not licensed in Nevada and he continued toadvise Oscar in areas beyond his expertise. While he was a nicegentleman and competent in basic planning, he had no conceptof advanced techniques appropriate for a physician earningover $1 million per year. He had no knowledge of non-qualifiedplans, asset protection or other fairly routine planning that weregularly implement for high-income physicians. While thisgentleman may have been an acceptable choice when Oscar wasa resident, it was a disservice at this point to continue to use thisattorney as his primary advisor.Doctors advise patients to get a second opinion before opting forsurgery or chemotherapy, but they don’t get their own “secondopinion” before agreeing to pay hundreds of thousands of dollarsEACH YEAR in taxes. In the example above, Oscar’s desire to “nothurt his attorney’s feelings” had potentially cost him over$1,000,000 so far.continued on page 4948 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

PRACTICE MANAGEMENT SOLUTIONScontinued from page 48Outgrowing a medical advisor may seem obvious to you. Youwould no longer send your child to a pediatrician when shebecomes an adult. Yet physicians are often reluctant to seek moresophisticated advisors as their needs evolve, despite a sense that theadvisor is no longer appropriate.Test: How did you choose the professional advisors you workwith today? How many other professionals did you interviewprior to choosing one? Have you periodically interviewed othersas your needs have changed?Fatal Flaw #2: Failing To Understand Sub-SpecialtiesIf you needed a stent in your aortic valve, you would not visit aninternist. Moreover, you would not consult with any specialists outsideof cardiology. In fact, you wouldn’t even settle with seeing thestandard cardiologist. You would seek an interventional cardiologistto perform the procedure. Medicine is a highly specializeddiscipline. If you have a specific issue, you will seek out the properlytrained and experienced physician.Our experience has shown that, in the areas of law, taxation andfinance, doctors fail to apply this same concept. To illustrate this,let’s consider the area of taxation. The ever-changing U.S. tax codeis the most complex set of rules ever created by one society. Thelengthy and confusing Internal Revenue Code is only the beginning.IRS revenue rulings, private letter rulings, tax memoranda,announcements and circulars—as well as tax court and Federalcourt cases—only make the field that much more difficult to understand.The quantity of information is so vast that many law librariesdevote an entire floor to tax materials. No single person can possiblybe an expert in all areas of tax law.Nevertheless, physicians typically rely on one CPA to serve astheir “tax advisor” in all areas of tax. Taxation issues that requireguidance typically include retirement planning, income structuring(salary vs. bonus), payroll tax, corporate structure (whether to be an“S” or “C” corporation), compensation (whether to implement adeferred compensation plan), estate tax planning, taxation on salesof real estate, individual tax returns, corporate tax returns and buyingor selling of the practice. While these issues all fall within thescope of “tax,” each exists as a sub-specialty with its own uniqueknowledge base. As if the generic “tax advisors” weren’t alreadyover-extended, they often provide guidance in areas far outside oftax altogether, such as asset protection or investing.We constantly encounter this scenario, trying to work with aphysician’s CPA or attorney to implement a particular strategy (i.e.,a non-qualified deferred compensation plan) and running intoroadblocks. In most cases, it is clear that the advisor has little experiencein the doctor’s area of concern. Ninety nine percent of thetime this occurs, the physician client suffers needlessly.The advisor is fearful of bringing in another advisor who may“steal” the client, nor will she admit her shortcomings and recommendanother specialist. The advisor could admit the lack of experienceand review the area in question to “get up to speed.” But mostadvisors are afraid to do this, possibly because they may not be ableto charge for that time, or the client may view them as “inadequate”or they may incur professional liability in operating out of their comfortzone. Instead, the advisor tells the client that the idea “doesn’twork,” without providing substantiation. Often, the doctor doesn’tsee what is really going on—and the problem is not solved.Test: Ask your CPA or attorney which tax areas noted above arehis expertise. Ask him how he would handle an issue for youbeyond this area.Test: Ask your tax advisor if she does asset protection planning.If the answer is yes, ask a follow up question: Which isbest from an asset protection perspective, an exempt cash valuelife insurance policy, a charging order protected entity or a selfsettledtrust?ConclusionPhysicians encourage patients to seek second opinions and relyon specialists to address their own complex medical needs.Physicians need to take their own advice. Your financial needs aresimilarly complex, and getting a second opinion and utilizing specializedadvisors is critical to your long-term financial well-being.Lori Adasiewicz is an attorney, instructor and author of For CaliforniaDoctors. She is a partner with Bay Laurel Law Group, LLP, a WealthStrategies Collaborative in San Mateo, California. For more information,please visit www.BayLaurelLaw.com. David Mandell is an attorney, lecturerand author of five books for physicians. Jason O’Dell is a financialconsultant, lecturer and author of two books for physicians. They are bothco-founders of the financial consulting firm O’Dell Jarvis Mandell, withover 1,000 doctor clients nationwide. Mr. Mandell and Mr. O’Dell welcomereaders’ questions at 800-554-7233 or at odell@ojmgroup.com.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 49

CALENDAR OF EVENTSDecember 2009December 9-12Current Concepts in JointReplacement Winter MeetingOrlando, FLwww.ccjr.comDecember 14-19Society of Military OrthopaedicSurgeons 51st Annual MeetingHonolulu, HIwww.somos.orgJanuary 2010January 6-9American Association for HandSurgery Annual MeetingBoca Raton, FLwww.handsurgery.orgMarch 2010March 6-9Orthopaedic Research Society AnnualMeetingNew Orleans, LAwww.ors.orgMarch 9Canaccord Adams MusculoskeletalConferenceNew Orleans, LAwww.canaccordadams.comMarch 10-13American Academy of OrthopaedicSurgeons Annual MeetingNew Orleans, LAwww.aaos.orgMarch 13Hip Society and AAHKS 38th OpenScientific Meeting/16th CombinedOpen MeetingNew Orleans, LAwww.hipsoc.orgMarch 10-14AAOS - American Academy ofOrthopaedic Surgeons AnnualMeetingNew Orleans, LAwww.aaos.orgMarch 14-17Society of Skeletal Radiology AnnualMeetingLas Vegas, NVwww.skeletalrad.orgMarch 24-27American Academy of Orthotists &Prosthetists 36th Annual MeetingChicago, ILwww.academyannualmeeting.orgApril 2010Association of Bone and JointSurgeons Annual MeetingWashington, DCwww.abjs.orgApril 21-25Mid-America OrthopaedicAssociation Annual MeetingLost Pines, TXwww.maoa.orgApril 27-30Spine Arthroplasty Society 10thAnnual SAS Global Symposium onMotion Preservation TechnologyNew Orleans, LAwww.spinearthroplasty.orgApril 28-May 1American Association of OrthopaedicMedicine 27th Annual ConferenceAmelia Island, FLwww.aaomed.orgMay 2010May 1-5American Association of NeurologicalSurgeons Annual MeetingPhiladelphia, PAwww.aans.orgMay 2-4American Association of OrthopaedicExecutives Annual ConferenceAnaheim, CAwww.aaoe.netMay 3-7Pediatric Orthopaedic Society ofNorth America Annual MeetingWaikoloa, HIwww.posna.orgMay 5-8The American Academy ofNeurological and OrthopaedicSurgeons 34th Annual ScientificMeeting & WorkshopsDenver, COwww.aanos.orgMay 20-23Arthroscopy Association of NorthAmerica 25th Annual MeetingHollywood, FLwww.aana.orgMay 23-26Current Concepts in JointReplacement Spring MeetingLas Vegas, NVwww.ccjr.comJune 2010June 2-5Association of Children's Prosthetic-Orthotic Clinics Annual MeetingClearwater, FLwww.acpoc.orgJune 2-5American College of Sports MedicineAnnual MeetingBaltimore, MDwww.acsm.orgJune 9-12American Orthopaedic Association123rd Annual MeetingSan Diego, CAwww.aoassn.orgJune 16-17OMTEC: Orthopaedic Manufacturing& Technology Exposition andConference 6th Annual MeetingRosemont, ILwww.orthoworld.comJune 22-25International Society for ComputerAssisted Orthopaedic Surgery AnnualMeetingParis, Francewww.caos-international.org50 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

SURGEON AS ENTREPRENEURU.S. Patent Office Expands andEnhances the First InterviewPilot ProgramAuthor: Perry E. Van Over, EsquireI have the pleasure of discussing the topic of this present article,which is a recent initiative by the Patent Office that should havevery positive results for the inventor/entrepreneur and patentapplicant: the “Enhanced First Action Interview Pilot Program.”In an earlier article, entitled “Resolving Prolonged Pendency ofPatent Applications; a Step in the Right Direction” (OPN,July/August 2008), I provided a summary of a First Interview PilotProgram that took effect on April 28, 2008. On that date, the U.S.Patent and Trademark Office (USPTO) initiated a pilot program inwhich the patent applicant, who complies with certain requirements,will receive the results of a prior art search conducted by theexaminer and then within a limited time period be permitted toconduct an interview with the examiner to discuss the cited priorart references prior to the first officeaction on the merits. That pilot programwas tested in a very limitedtechnology area and with a limited filingdate window of opportunity. Atthat time, the only two groups ofpatent applications that were eligiblefor participation in the pilot programwere those classified in Class 709(Electrical Computers and DigitalProcessing Systems: Multi-ComputerData Transferring) and Class 707(Data Processing: Database and FileManagement or Data Structures). Inthat earlier article I made the pointthat although the concept was verypromising, the initial pilot programwas very limited and would thereforehave no immediate impact on patentprosecution of surgical devices,implants or instruments. Fortunately,the initial and very narrowly defined pilot program has yielded sufficientlygood results so as to prompt the USPTO to expand the pilotprogram into more diverse technology areas and to revise the proceduresof the pilot program in ways that are beneficial to the patentapplicant.The Enhanced First Action Interview Pilot Program has, as ofOctober 2009, been expanded to include diverse technologies thatare examined in over 30 additional Patent Office Art Units. Thesenew technology areas range from computers, cell phones, navigationaldevices, well-digging, boring and other technologies that tothe readers of this publication may seem uninteresting. It is in the“It is clear that if the examinerhad the benefit of a betterunderstanding of the inventionand how it is distinguishedover the relevantprior art much earlier in theprocess, the entire dialoguebetween applicant and examinerwould be more meaningfuland productive.”“other technologies” groups that the surgeon, inventor/entrepreneurwill be interested. Among the Patent Office Art Units includedin this first expansion of the pilot First Action Interview PilotProgram are some Art Units that are grouped under TechnologyCenter 3700, “Mechanical Engineering, Manufacturing andProducts.” Specifically, Art Units 3735-3737, 3739, 3762, 3766, 3768and 3769 are now designated as participating Art Units in theexpansion of the pilot program. The technologies that are dealt within one or more of these listed Art Units include surgery and prosthetics.For some readers the inclusion of those particular Art Unitsmay be very good news. Unfortunately, not all surgical devices andmethods are included in those few surgery Art Units now includedin the pilot program.When a patent applicant files hispatent application, the USPTO willmake a judgment as to which ArtUnit is most appropriate to examinethe application. Considering thatthere are only eight Art Units thatcarry the general descriptor of “surgery”or “prosthetics,” it is obviousthat a patent for a surgical instrumentsubmitted for examinationmay be assigned to Art Unit 3735 orArt Unit 3736, etc. However, anewly filed patent applicationdirected to a surgical instrumentand/or surgical method may also beassigned to 3733, 3775, 3655 or someother Art Unit that also bears thegeneral description of “surgery,”but is not listed as part of this firstexpansion of the pilot program. Forthose who do file a patent applicationand discover that the invention has been assigned to one of theincluded Art Units, the opportunity to participate in the EnhancedFirst Interview Pilot Program should be carefully considered. Thosewho find their surgery-related patent application not included atthis time should still become aware of the possible advantages ofthe pilot program and look forward to the day (hopefully verysoon) when the pilot program will be further expanded to includetheir invention application. Considering the prolonged time of pendencyfrom the filing date of an application to the date when anExaminer first examines the application on the merits, it is very pos-continued on page 5452 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

SURGEON AS ENTREPRENEURcontinued from page 52sible that an inventor filing an application today that is assigned toa non-participating Art Unit will still eventually be able to takeadvantage of the first action interview procedure. Recognizing thatsome surgery related patent applications will now be able to participatein the Enhanced First Action Interview Pilot Program, let usnow review the procedures and benefits offered by the initial pilotprogram and then turn our attention to the enhanced procedures,which have just become effective as of October 1, 2009.Prior to the initiation of the First Action Interview Pilot Programon April 28, 2008, the normal Patent Office policy was to not allowan examiner’s interview for the purpose of discussing patentabilitybefore the first Office Action on the merits,except in cases of a continuing or substituteapplications. The opportunity providedthrough the revised examiner’s interviewpolicy, as tested by the initial pilot program,improved the early communicationand understanding between the patentexaminer and the applicant and greatlyincreased the likelihood of an early andfavorable result of the patent prosecutionprocess.For those patent applications that arenot included in the pilot program, the filedapplication is presented to the patent examineronly as a printed application thatdescribes how to make and use the inventionin the specification and specificallydefines the invention to be protected in the claims section of theapplication. Until the advent of the initial pilot program, it wasaccepted that the examiner’s sole reliance on the application aswritten would be sufficient to support his complete understandingof the invention and no benefit of a personal exchange between theexaminer and the applicant was permitted. This expectation is reasonable,since the patent application to be in compliance with U.S.patent laws must teach how to make and use the invention so as toenable one of ordinary skill in the art to practice the invention.While legally correct, the expectation that the patent examiner willclearly and fully understand the invention as described andclaimed in the application after a first reading and examination is anaive understanding of what the initial examination of the applicationinvolves.Depending upon the technology and the complexity of a particularinvention, the written specification can be lengthy, complicatedand contain multiple embodiments of the invention in addition tothe required best mode envisioned by the patent applicant. In additionto reading the application, the examiner must determine all classificationswithin which to conduct his prior art search and mustthen carefully search for and study all possibly relevant prior artpublications before drafting his first written Office Action on themerits. Frequently, the blended technologies that contribute to thewhole invention will require the assigned patent examiner to consultwith patent examiners working in other unrelated Art Units andthen to conduct prior art searches in those ancillary technologyareas. An example of such a requirement might be a complex surgicalendoscopic instrument such as trocar that includes novelhydraulic fittings for irrigation and suction lumens, as well as opticsand laser capabilities included within the mechanical trocar device.Such an invention commonly requires that the assigned patentexaminer expand his search far beyond the typical surgical realm.Depending upon the current state of the technology involved and“The procedure for theEnhanced First ActionInterview Pilot Programoffers more benefitsand flexibilities to theparticipants than theinitial pilot program.”the volume of prior art that must be screened for relevance to theclaimed invention, this initial effort, if thoroughly done by the examiner,can require much more time than he is provided under the productivitypolicies of the Patent Office. The time allotted for an examinerto do his work varies by his area of technology and his level ofexperience, but in no case can the few hours provided by PatentOffice productivity policies be sufficient for the examiner to fullyunderstand all that is placed in front of him as well as it is understoodby the inventor and his attorney, who typically have spentmany times the number of hours inventing, testing and creating awritten application description of the invention. Under conventionalpatent prosecution policies, the examiner is denied the benefit ofinvolving these individuals who are much more familiar with theclaimed invention.In consideration of the extensive effortsrequired of a patent examiner for his initialstudy of a patent application, it is clear thatthe examiner will have some difficulty incoming to a full and accurate understandingof the written disclosure of the inventionrelative to the conventional prior artwhen so few hours are allotted. For this reason,it is common for the examiner’s firstOffice Action to be less precise and useful tothe patent prosecution process than it couldbe. Often it is the applicant’s response to thefirst Office Action that assists the examinerin coming to a better understanding of thedifferences between the claimed inventionand the prior art cited in the Office Action.As a result, the second Office Action can be researched and draftedby the examiner with greater clarity and precision. Because this secondOffice Action by the examiner is often a Final Office Action, theapplicant has only a limited possibility through the submission of anAfter Final Amendment to convince the examiner of the patentabilityof the claims. It is important to understand that the examiner hasthe option of denying entry of the After Final Amendment into thepatent application record. For this reason, the conventional patentexamination procedures where the examiner is forced to develop hisinitial understanding of the invention without benefit of communicatingwith the applicant often results in the applicant having a verylimited opportunity to convince the examiner of the patentability ofhis claimed invention.Patent Office policy currently permits an applicant to requestand be granted an interview with the examiner after the first OfficeAction on the merits. Often these Examiner’s Interviews prove veryhelpful because they afford an opportunity for the applicant tobring certain aspects of the invention, which may have been overlookedin the initial examination, to the examiner’s attention. Thepersonal interview, even if conducted telephonically, allows theinventor/applicant to discuss or to teach as necessary the criticalaspects of the invention that, while fully described in the writtenspecification, were not well understood or properly weighted bythe examiner during his initial and often hurried first look at thepatent application. The Examiner’s Interview allows an unfettereddiscussion of the essence of the invention, the reality of the prior art,and the applicant’s understanding of the patentable distinctionbetween them. It allows the examiner the opportunity to hear andunderstand precisely what the inventor discovered in the newinvention and to see that discovery through the inventor’s eyes.Frequently this dialogue, this exchange of view points, allows theinventor and examiner to come to a mutual understanding of whatcontinued on page 5554 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

SURGEON AS ENTREPRENEURcontinued from page 54the invention is and how it is distinguishable over the relevant priorart. Upon this basis, the applicant can then provide a meaningfuland effective Response/Amendment to the examiner’s OfficeAction and the application, if deserving, can proceed to allowanceand issuance as a U.S. patent.It is clear that if the examiner had the benefit of a better understandingof the invention and how it is distinguished over the relevantprior art much earlier in the process, before he is required to submit afirst Office Action on the merits, the entire dialogue between applicantand examiner would be more meaningful and productive. The applicantwould then, in fact, have an improved opportunity in his submissionof the first Response/Amendment to satisfy the examiner’sobjections, because those objections would be founded on a muchimproved understanding of the invention. It is thus conceivable thatthe number of first action allowances, which are relatively rare today,could increase substantially if the first Office Action and the firstResponse/Amendment were better done thanks to the improvedunderstanding of both parties’ positions early in the prosecutionprocess. This improved understanding by the examiner early in theprocess would be a direct result of the opportunity for the applicant tointerview with the examiner before he issues his first Office Action.Having an understanding of the basic process and advantages ofthe first action interview, let us now briefly consider the enhancementsto the process as permitted by the recently initiatedEnhanced First Action Interview Pilot Program.First, as already discussed, the Enhanced program expands thepilot program across many more and varied Art Units in theTechnology Centers of the USPTO. Importantly, some of thosenewly involved Art Units are dedicated to examining patents relatedto surgery.Second, under the enhanced pilot program, after receiving thePre-Interview Communication from the patent examiner, the applicantis given greater flexibility in selecting the level of the revisedprocedures they will need to advance the patent prosecution duringthe period of the pilot program. Under the initial pilot program, allparticipating patent applicants had to go through all phases of theprescribed test process in a lock-step fashion.A third revision to the pilot program allows the time period setfor a reply to the examiner’s Pre-Interview Communication to beextendable by one additional month. Under the initial pilot program,the time period established for the applicant’s reply to theexaminer was non-extendable.A final major improvement to the processes prescribed for thepilot program is that if the applicant fails to timely reply to the Pre-Interview Communication or to timely conduct the first actioninterview, the result will be that the examiner will proceed to entera first office action on the merits similar to waiving the interviewand much the same as the process of a conventional non-pilot programprosecution procedure. In the initial pilot program, the rulesset down for the pilot program test period if a timely reply was notmade by the applicant the application was abandoned. Needless tosay, this harsh rule of the initial pilot program procedure discouragedapplicants for voluntarily entering the pilot program.The procedure for the Enhanced First Action Interview PilotProgram offers more benefits and flexibilities to the participantsthan the initial pilot program. Therefore, for applications in whicha request for the initial First Action Interview Pilot Program hasbeen accepted by the USPTO, but a Pre-Interview Communicationhas not been provided to the applicants, the application will beprocessed under the procedure for the Enhanced First ActionInterview Pilot Program.The intention of this article is only to provide the reader with anupdate of the Enhanced First Action Interview Pilot Program andthe initiative to involve some surgery related patent applications inexpanded program. If successful, the pilot program will probablybe fully incorporated into U.S. Patent Office patent prosecution proceduresand serve to promote an early substantive dialogue thatmay dramatically increase the understanding and cooperationbetween the inventor and the examiner. It can be reasonably expectedthat the improved early communication and understanding willresult in faster, fairer, and more effective prosecution of patents bythe USPTO. This article is not intended as legal advice but is providedonly to make the inventor/entrepreneur aware of this new pilotprogram and the possible benefits that it may represent.Perry Van Over is the Founding Member of Perry E. Van Over &Associates, PLLC, an intellectual property law firm specializing in patentprocurement, licensing and litigation in the technical fields of surgicalinstruments, medical devices, molecular biology, pharmaceuticals, biochemistryand polymer chemistry. He can be reached at 703-543-6456 orperryvanover@verizon.net.I am pleased to submit the following update to a topic Ibrought to your attention in my earlier article entitled “TheRules of the Road Are Changing for Patents,” (OPN,November/December 2007) That earlier articleaddressed the details of the USPTO effort to change therules of patent practice as it relates to “Claims andContinuations.” Responding to a court challenge to thoseproposed rule changes, the U.S. District Court, EasternDivision of Virginia on October 31, 2007 issued a preliminaryinjunction enjoining the USPTO from implementingchanges in the Claims and Continuations Final Rule.Readers are invited to review my earlier article in which Isummarized the proposed patent rule changes and presentedarguments as to why the proposed changes weremisguided and contrary to improving the operation of oursystem of patent laws in this country. I am now verypleased to report that the USPTO has reversed its position.The Under Secretary of Commerce for IntellectualProperty and Director of the USPTO, David Kappos, hassigned a new Final Rule rescinding the highly controversialregulations that, had they gone into effect, wouldhave unduly restricted an inventor’s capacity to protecthis intellectual property. As recognized by UnderSecretary Kappos, “The USPTO should incentivize innovation,develop rules that are responsive to its applicants’needs and help bring their products and services to market.”In rescinding the proposed rules, Kappos also said.“These regulations have been highly unpopular from theoutset and were not well received by the applicant community.In taking the actions we are announcing today, wehope to engage the applicant community more effectivelyon improvements that will help make the USPTO moreefficient, responsive, and transparent to the public.” Thisaction in rescinding the proposed rules is a major victoryfor the inventors and patent applicants in this country.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 55

RESEARCH TO REALITYBuilding a Successful GrantFunding TeamAuthor: Chris PrzybyszewskiPlease retain formatting in this article. For instance, italicization.Many orthopaedic surgeons express a desire to perform research,and there is wide consensus that those physicians who engage inthe development of the technologies that will later help patients canreturn substantial personal, career and monetary benefits.At the same time, as with most any enterprise, funding the activitiesto perform successful research can be a barrier to entry. Frequently,I hear orthopaedic surgeons describe the entire funding process as agame that requires a clear goal, teamwork, a strategy and execution.A most common question is, What percentage of people applyingfor funding actually receives it? Referring to Tables 1 and 2, it isclear that any grant proposal process is extremely competitive.Table 1: OREF grant applications funded 2005 through 2007TYPE OF GRANT 2005 2006 2007ResearchResearch Number of58 47 55Number Applications of58 47 55ApplicationsNumber Funded 7 9 10Number Percentage Funded Funded 12% 7 19% 9 18% 10Percentage FundedRange of Scores12%1.00 - 1.3019%1.18 - 1.4718%1.35 - 1.81Range of Scores 1.00 - 1.30 1.18 - 1.47 1.35 - 1.81CareerCareer Number ofNumber Applications 13 15 9ofApplicationsNumber Funded 13 3 15 2 91Number Percentage Funded Funded3 2 123% 13% 11%Percentage FundedRange of Scores 1.34 23% - 1.60 1.16 13% - 1.26 11% 1.51Range of Scores 1.34 - 1.60 1.16 - 1.26 1.51ResidentResident Number ofNumber Applications 42 39 35ofApplicationsNumber Funded 42 8 39 9 35 8Number Percentage Funded Funded8 9 819% 23% 23%Percentage FundedRange of Scores 1.44 19% - 1.98 1.35 23% - 2.05 1.53 23% - 1.89Range of Scores 1.44 - 1.98 1.35 - 2.05 1.53 - 1.89Prospective ClinicalProspective Number of ClinicalNumber Applications 16 14 15ofApplicationsNumber Funded 16 1 14 1 15 2Number Percentage Funded Funded1 1 26% 7% 13%Percentage FundedRange of Scores 6% 1.33 7% 1.38 1.28 13% - 1.35Range of Scores 1.33 1.38 1.28 - 1.35Source: Orthopaedic Research & Education FoundationFor example, one of the primary sources for research funding fororthopaedic surgeons is the National Institute of Arthritis andMusculoskeletal and Skin Disease (NIAMS). According to that institute,the acceptance rate for those proposals that were reviewed (myemphasis) was 23 percent of all applications from 1998 to 2007.However, as indicated by the table, that percentage has dropped inrecent years partially due to less funds (because of economic trendsand political movements, more than anything else), and also anincrease in applications.As well, the note under Table 2 that “Success rates indicate thepercentage of reviewed research project grant (RPG) applicationsthat receive funding” is important, since roughly half (or less) of allproposals submitted to the NIAMS are reviewed and scored, as allNational Institutes of Health (NIH) agencies will quickly weed outthose proposals that the reviewers do not feel are competitiveenough for a full review. This practice cuts in half the success ratesin Table 2. Finally, it’s important to note that NIAMS success ratesare markedly lower than the other NIH agencies.Complementing these numbers are those from the OrthopaedicResearch & Education Foundation (OREF), whose success rates arecomparable (though somewhat lower) than the NIAMS. Whilethese groups are independent of one another, their proposal andreview processes are by design quite alike, so it makes some sensethat their numbers match.Looking past the simple (and perhaps disheartening) percentages,perspective is important, and perhaps the game analogy can again beuseful here. How many NFL football teams win each Sunday? Theanswer is that roughly 50 percent of the teams who play will win.However, the winning percentages of good teams is far higher.The same is true with proposals. Good teams are more competitiveto win these proposals, and building or being a part of a successfulteam can make all the difference in the world.The “Team”There has been a steady shift in grantors’ minds that collaborationis an essential element to successful research. Therefore, it’sbecome common for multiple primary investigators to seek fundingas a group. This funding team is usually multi-disciplinary andincludes experts from academia, clinical work and even industry.As well, each of these team members are usually recognized expertsin their fields, meaning multiple publications in peer-reviewedcontinued on page 5756 ORTHOPAEDIC PRODUCT NEWS • November/December 2009

RESEARCH TO REALITYcontinued from page 56Table 2: History of NIAMS competing research project grants (RPG)Fiscal Year Total Number of Awards Total Dollars Awarded Average Cost Percentile Payline NIAMS Success Rate NIH Success Rate1998 1998 225 $46,971,000 $46,971,000$208,76020 28.10% 31.10%1999 1999 195 $51,931,000 $51,931,000$266,31320 24.40% 32.40%200020012002200320042005200620072000 238 $62,278,000 $62,278,000$261,67224 27.40% 31.50%2001 281 $77,244,000 $77,244,000$274,89024 28.60% 32.10%2002 257 $74,806,000 $74,806,000$291,07421 23.20% 31.20%2003 242 $75,109,000 $75,109,000$310,36818.5 20.40% 29.90%2004 245 $73,147,000 $73,147,000$298,55917 20.10% 24.60%2005 244 $74,842,000 $74,842,000$306,73016 20.20% 22.30%2006 247 $77,412,000 $77,412,000$313,40914.5 19.30% 20.00%2007 261 $75,954,000 $75,954,000$291,01115 20.00% 21.30%Note: Success rates indicate the percentage of reviewed RPG applications that receive funding.Source: www.niams.nih.gov/About_Us/Budget/rpg_history.aspjournals. A notable exception can be new researchers who supportthe work of the primary investigators.Frequently, the relationship amongst team leaders is symbiotic.A researcher leading one project might use a team member as a consultant,but then in turn consult for that team member’s later orconcurrent project. It’s appropriate that team members be involvedin several mutual projects. What’s important is that membershipinto the team must be mutually beneficial, and that everyone on theteam contributes to each project.As a final note of team composition, it is integral that team membershave previous grant funding. Reputation is a cornerstoneattribute, and a successful history of funding can be an essentialasset in winning grant proposals. In those cases that none of theteam members has won a grant, it might be good to strategize howthe team could recruit a new member who fills this criterion.Team dynamics, obviously, can be a dominating factor. Teammembers must be willing to contribute evenly, give up some levelsof control to team mates, and perhaps most importantly, shareresources (including funds, personnel, equipment and space). Thiscan lead to research that is important and successful, and whichmight not have been the research project the surgeon wanted toconduct in the first place!The time of the lone researcher and pet projects is over, and successfulresearchers understand that their contributions are amplifiedten to a hundredfold within the right team set-up.Multi-disciplinary and multi-institutional collaboration is notthe simplest goal to achieve, and researchers must work closelytogether and with their administrative counterparts who will overseeall official budgets, non-disclosure agreements and intellectualproperty agreements (among many other agreements!). The administrativecounterparts will also be integral in managing the grantmonies and keeping track of costs, because in most every case,grantors want detailed and exhaustive reports on how the fundswere spent and the results of the research—the “bang for yourbuck” so to speak. These reports can become the backbone of arenewal proposal to continue funding.Getting StartedIn many cases, successful clinician scientists are born, not bred,in that they attend medical schools or graduate programs withmentorship that sets them in the right place from the beginning oftraining. Starting with a less-than-pedigreed research resumé andfew resources with a goal of achieving the highest levels of fundingcan seem like a nearly-impossible task.However, with the right perspective and strategy, the task isquite possible. To start, find those in the field who are doing theresearch you are doing, and who are being paid in grant dollars forresearch in the field. Find them in journals and in professional conferences,and connect with them. Get their advice, and most importantly,find out how you can become a player on their researchteam, subcontracting some part of their existing grant programs.These connections will allow you to add valuable references andresearch partners to your future proposals, as well as get you in theloop in terms of opportunities available. As you continue to helpthese partners, you’ll soon be able to direct your own research. Foryour own proposals, one way to move forward includes traininggrants offered by a variety of government agencies and privatefoundations. These cover early career clinician scientists as well asmid-career physicians who would now like to transition intoresearch. Earning one of these degrees, along with your connections,can set you in a very competitive place.Sourceswww.niams.nih.govwww.oref.org/grantswww.grants.govChris Przybyszewski is the Director of Grants & Communications at theInMotion Orthopaedic Research Center. InMotion's mission is to acceleratescientific discoveries in orthopaedics that enhance personal mobility,leading to greater individual freedom and a more fulfilling life. Chris canbe reached at chris@inmotionmemphis.org.November/December 2009 • ORTHOPAEDIC PRODUCT NEWS 57

GIVING BACKSIGN Starts Three Beta Sites onEast Africa TripAuthor: Lewis G. Zirkle, Jr., M.D.I travelled with Jeanne Dillner, the Chief Executive Officer of theSurgical Implant Generation Network or SIGN, to East Africa toestablish three new beta sites for the device we have been developingto stabilize hip fractures. SIGN engineers have worked on thedesign and performed bench testing over the course of three years.We increased our efforts after seeing 20 patients in traction in onehospital in Afghanistan. We were told that after three weeks theywould be placed in body casts and sent home. Electricity was on foronly three hours per day, and the temperature was freezing.The three new beta sites for hip fixation trials in East Africaincluded Muhimbili Orthopaedic Institute in Dar es Salaam,Tanzania; Mulago Hospital in Kampala, Uganda; and MOI Hospitalin Eldoret, Kenya. These proved to be excellent choices, as each ofthem had scheduled four hip cases that could be operated on withthe SIGN Hip Construct (SHC). The most challenging fractures hadoccurred three months prior. The surgeons also had collectedunusual long bone fractures in which the SIGN nail could be usedin unique ways. As with the SIGN IM Nail System, the SHC isimplanted without a C-arm, which means surgeons use their tactilesenses to place the implants. The SIGN surgeons at all three sitesperformed the surgery very well. We all learned from the surgicalchallenges as well as from each other. A three-month delay in treatmentis acceptable in treating long bone fractures, but not for hipcases, because the hip fractures occur in softer bone. When onetakes out the healing callus, only the shell of cortical bone is left.Another patient had a fractured femoral shaft as well as a hip fracture,so we had to allow for the rotation of the nail to accommodatethe interlocking screws in both hip and shaft fractures.During each visit, I emphasize two or three new ideas for implementationby SIGN surgeons. One teaching point which I practice isto think about each surgery the night before. Like the quarterbackwho visualizes each play and anticipates the potential reaction by theopposing team, I teach the surgeons to think about each situation theymay encounter and how to react to get the best result for the patient.One of the challenging long bone fractures presented us withmany teaching points. Seventy-year-old Badasa Muhula had a fracturedfemur and an arthritic knee which deviated 45° into valgus.She told us that her worst pain was in her knee and she would likethis to be corrected at the same time. She could not afford to buy aknee replacement device, but the SIGN system was available andfree to her. Dr. Lectary Lelei and I discussed this case with the othersurgeons the day before and developed a rough game plan, whichwe implemented the next day. We first placed one nail down thefemur to stabilize the fracture. We removed wedges from the tibiaand femur to straighten the knee, and then made a slot in the femurand placed the nail across the knee joint into the tibia. We placedinterlocking screws through this nail on both sides of the knee joint.When she awakened and saw her straight knee, she was veryhappy. Badasa was recuperating on the Sylvester Neal Ward.Sylvester Neal is the vice president of Kiwanis International, whichhas been very helpful in raising funds. This program has beensponsored by Kiwanis.We were rewarded on this trip with many challenging surgeries.Another reward occurred when I heard the surgeons talking aboutthe thinking surgeon at dinner. I had emphasized this because ourSHC has many components and variables which can be used in differentways. It is not a cookbook operation, in which the surgeonfollows specific steps dictated by the implant company. Each step ofthe way, the surgeon must make a decision and think of its consequences.The school system in East Africa is one based on rotememory. The thinking surgeon is a departure from this. This changein attitude provided me with great pleasure and satisfaction.SIGN has many facets. Attendees at the annual SIGN conferenceoften remark about the SIGN culture. The human element is farmore important than the implants. Having a high regard for thepatient makes the surgeon strive to do his best. This means thatmost waking hours are devoted to thinking about how to treatpatients optimally. Each patient comes in with a different problemfrom the last or from any other patient. They must be treated asindividuals yet follow principles which have been known foryears. That's the art of medicine.Lewis G. Zirkle Jr. M.D. is a board certified orthopedic surgeon in privatepractice in Richland Washington. He graduated from Davidson Collegeand Duke University Medical Center. He was selected to continue atDuke University Medical Center for surgical and orthopedic surgerytraining but was drafted into the U.S. Army and sent to Vietnam. Hecontinued his training in the Army.Experience in the Army convinced him that many people are caught inthe middle of a conflict or an accident for which they have no control. Theyare injured and must be cared for. This may apply to civilians caught inthe middle of a conflict, disaster victims and most people caught in a risingepidemic of injuries in the world.He has traveled extensively in developing countries to teach orthopedicsurgery. In 1994 he realized that training is not sustainable unlesssurgical implants to stabilize fractures are donated along with teachingabout fracture care. SIGN was formed on that premise.Since SIGN was founded, he has spent increasing amounts of timeengaged in development of new surgical implants which can be used indeveloping countries, developing curriculum applicable to the surgeons,and traveling to teach surgery and modern orthopaedic care. He is passionateabout SIGN’S Mission and vision. He can be reached atsigncom@sign-post.org.58 ORTHOPAEDIC PRODUCT NEWS • November/December 2009