Hip & Knee Surgery - Orthoworld

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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
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