and the Bone Dowel Harvester: - Biomet

and the Bone Dowel Harvester:A slippage resistant, stiff, strong fixation combination for the tibia.

Proven Strategies for ACL Reconstructionand the Bone Dowel Harvester:A slippage resistant, stiff, strong fixation combination for the tibia.Rationale and Technique for Fixing a Soft-Tissue ACL Graft tothe Tibia with the WasherLoc Device and Autogenous Bone DowelAt the time of implantation, the WasherLoc Tibial FixationDevice and autogenous bone dowel have the mechanicaladvantage of providing the most slippage resistant, stiffest, andstrongest fixation combination for tibial fixation of a soft tissue4, 12, 17, 20, 23anterior cruciate ligament graft.After implantation, the WasherLoc Device and autogenousbone dowel used together have the biologic advantage ofencouraging circumferential tendon-tunnel healing, 22 reducingthe potential for tunnel widening, 18 maintaining stability in theface of the obligatory tension loss in the graft, 7 and lowering thetension in the graft during open-chain exercise, 13 all of which canallow for brace-free, aggressive rehabilitation.Combining the EZLoc Femoral Fixation Device with theWasherLoc Tibial Fixation Device and autogenous bone dowelprovides a comprehensive fixation combination to resist slippageof the soft-tissue graft with respect to the fixation device andslippage of the fixation device in bone during the first month ofbrace-free, aggressive rehabilitation. 23Although the WasherLoc and EZLoc devices are considered“distal fixation devices,” they have demonstrated restoration of thesame anterior laxity 16 and provide better stiffness than intratunneldevices. 16 Distal fixation devices have less slippage, 2,5,14 less tunnelwidening, 1,18 and provide greater surface area (i.e. circumferentialcontact) for tendon-tunnel healing, than intratunnel devices. 12,18,22This brochure is presented to demonstrate the surgical technique utilized by Stephen M. Howell, M.D. Biomet Sports Medcine, as the manufacturer of this device, doesnot practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsiblefor determining and utilizing the appropriate techniques for such procedure for each individual patient. Biomet Sports Medicine is not responsible for selection of theappropriate surgical technique to be utilized for an individual patient.Rehabilitation activities vary depending on the individual patient and physician’s recommendations.The WasherLoc Tibial Fixation Device and the EZLoc Femoral Fixation Device were developed in conjunction with Stephen M. Howell, M.D., Sacramento, California.

Advantages of Soft Tissue ACL GraftsThe double-looped semitendinosus and gracilis (DLSTG)hamstring graft is the strongest and stiffest autogenous graftavailable, 8, 17 and the single-looped tibialis allograft is the strongestand stiffest allograft available. 9, 19 Both of these soft-tissue graftshave less harvest morbidity compared to other autogenousgraft sources. The DLSTG autograft and the tibialis allograftare not normally associated with the complications of a bonepatellartendon-bone graft which include quadriceps weakness,patellar fracture, patellar tendon rupture, anterior knee pain, anddegeneration of the articular surface of the patella-femoral joint.Most surgeons prefer the soft-tissue ACL graft because of itsstructural properties, minimal or non-existent harvest morbidity,and ease of rehabilitation. 10,11Limitation of Tendon-Tunnel HealingWays to improve the fixation strength of a tendon graft areneeded because the biologic bond is only half as strong as abone-patellar tendon-bone graft at three weeks. 24 By four weeksthe tendon-tunnel interface provides most of the fixation strengthoffloading the mechanical strength provided by the fixationdevice. 25 However, it isn’t until six weeks that the strength of thebiologic bond of the tendon-tunnel interface equals that of thebone-patellar tendon-bone graft. 24 Therefore, during the first sixweeks of implantation, the fixation method of a soft-tissue graftmust provide more slippage resistance, stiffness, and strength thanthe fixation used with a bone-patellar tendon-bone graft. 24Enhancing Tendon Tunnel HealingThere are several ways to improve the healing, strength, andstiffness of the tendon-tunnel biologic bond within the firstsix weeks of the reconstruction that might benefit clinicaloutcome. 18,22,24 The use of a longer tunnel provides more surfacearea for bonding. 6,22 The addition of autogenous biologic materialinside the tunnel alongside the soft-tissue graft tightens the fitand improves tendon-tunnel contact. 15 Finally, the use of distalfixation devices instead of intratunnel fixation devices, allowscircumferential rather than one-sided healing of the tendon to thetunnel wall. 22 Each one of these factors are known to improve thehealing, strength, and stiffness of the biologic bond. 6,15,16, 22 Thesefindings suggest that the principles for improving early healingand biologic fixation include the use of slippage resistant, stiff, andstrong distal fixation devices in conjunction with compaction ofbone into the tunnel alongside the soft tissue graft. Collectively,the fixation combination of the WasherLoc Device, EZLoc Device,and Bone Dowel provide long, tight fitting tunnels that allowcircumferential tendon-tunnel healing.Reducing the Need forHardware RemovalRemoval of painful prominent hardware continues to be the mostcommon reason for additional surgery using a hamstring graft,with the incidence ranging from 12 to 26%. 3,11,21 The WasherLoc Device may minimize discomfort with kneeling or impact, 11because the average prominence of the WasherLoc Device is only2mm, which is significantly less than other tibial fixation methodssuch as staples (7mm) and washers (7 to 8mm). 17

Surgical TechniqueFigure 1Figure 3Figure 2Figure 4Harvest a Bone Dowel fromthe Tibial TunnelPlace the 2.4 mm guidepin for the tibial tunnel. Choose acannulated reamer matching the diameter of the soft tissue ACLgraft. Advance the cannulated reamer until it just breaks throughthe distal tibial cortex (Figure 1).Assemble the Bone Dowel Harvester bylocking the collet in the quick release handle.Next, lock the 8mm in diameter harvestertube into the collet (Figure 2). Slide thecalibrated plunger over the tibial guidepinuntil it rests inside the tibia (Figure 3). Slidethe 8mm in diameter harvester tube overthe plunger until it rests on cancellous bone.Impact the Bone Dowel Harvester over theguidepin to subchondral bone (Figure 4 & Figure 55). Rotate the Bone Dowel Harvester several times clockwise andcounterclockwise to break off the cylindrical bone dowel and thenpull to remove (Figure 6).Figure 6

Figure 7Figure 8Disengage the collet from the handle. Read the calibrated plungerand determine the length of the bone plug (typically 25–35 mm)(Figure 7). If the guidepin was removed with the Bone DowelHarvester, then re-insert the guidepin into the notch by insertingan 8mm femoral reamer into the tibial tunnel and then passing aguidepin through the cannulation and through the tibial plateau(Figure 8). Finish drilling the tibial tunnel with the cannulatedreamer that matches the diameter of the graft (Figure 9).Figure 9

Figure 13Figure 15Figure 14Figure 16Select the Correct SizeWasherLoc DeviceSelect the 16mm Extended Spike WasherLoc for a 7 or 8mmdiameter graft. Select the 18mm Extended Spike WasherLoc for a9 or 10mm diameter graft. Thread the WasherLoc Device on thedrill guide and thread the drill guide on the awl (Figure 13).Tension the Graft and Impact theWasherLoc DeviceAfter fixing the graft to the femur with the EZLoc FemoralFixation Device, manually tension the graft and cycle the knee fullextension to maximum flexion. Tensioning the graft and cyclingthe knee seats the EZLoc Device and removes slack in the graft.Place the knee in maximum hyperextension and maintain thisposition by resting the heel on Mayo stand. Place an impingementrod between the sutures attached to the tendons and have anassistant tension the graft in line with the tibial tunnel by pullingon the rod (Figure 14). Rotate the WasherLoc Device so that theflat edge faces the distal end of the tibial tunnel (Figure 15). Placethe tip of the awl between the limbs of each tendon and use aright-angle clamp to maneuver the graft under the WasherLoc Device so that all four bundles are contained within the fourlonger extended spikes (Figure 16). Impact the WasherLoc Deviceusing a mallet (Figure 17).Figure 17

Figure 19Figure 18Figure 20Drill, Measure and Insert theCancellous Compression ScrewMaintain tension on the graft. Unscrew and remove the awl fromthe drill guide. Insert a 3.2mm drill bit through the drill guideand push the cutting tip past the tendons (Figure 18). Protect theneurovascular structures by carefully drilling toward the fibulaand through the LATERAL tibial cortex without plunging into thesoft tissues. Unscrew the drill guide, insert the depth gauge, andmeasure the length of the tunnel (Figure 19). Momentarily leavethe depth gauge in place and adjust the overhead light until thedepth gauge casts a shadow on the thigh. Mark the long axis ofthe shadow casted by the depth gauge. Screw the appropriatesized self-tapping cancellous compression screw into the tibia.Keep the shadow of the shaft of the screwdriver in line with axis ofthe depth gauge while advancing the compression screw(Figures 20 and 21).Figure 21

Figure 22 Figure 23Compact Bone Dowel intothe Tibial TunnelCompact any nothchplasty remnants and bone reamings into thedilated opening with the dilator or an impingement rod. Place theplastic graft protection sleeve over the cutting tip of the harvestertube (Figure 22). Position the harvester tube over the dilatedopening of the tibial tunnel. Impact the calibrated end of theplunger with a mallet until it is flush with the collet, compactingthe cylindrical bone dowel into place (Figure 23). Reinsert thearthroscope into the joint and confirm that bone graft has notbeen impacted into the joint through the tibial tunnel.Completed technique with WasherLoc Device and added bone dowel.

Assess Placement of WasherLoc Device and BoneDowel on Post Operative RadiographsThe WasherLoc compression screw should course toward thefibula from anteromedial to posterolateral and exit throughthe LATERAL cortex of the tibia (open circle), which avoidsneurovascular structures. On the AP view the WasherLoc Deviceshould be parallel to the back wall of the tibial tunnel. The bonedowel should fill the anteromedial section of the tibial tunnel(irregular line).References1. Buelow JU, Siebold R, Ellermann A. A prospective evaluation of tunnel enlargementin anterior cruciate ligament reconstruction with hamstrings: extracortical versusanatomical fixation. Knee Surg Sports Traumatol Arthrosc. 2002;10(2):80-85.2. Caborn DN, Brand JC, Jr., Nyland J, Kocabey Y. A biomechanical comparison of initialsoft tissue tibial fixation devices: the Intrafix versus a tapered 35-mm bioabsorbableinterference screw. Am J Sports Med. 2004;32(4):956-961.3. Clark R, Olsen RE, Larson BJ, Goble EM, Farrer RP. Cross-pin femoral fixation: a newtechnique for hamstring anterior cruciate ligament reconstruction of the knee.Arthroscopy. 1998;14(3):258-267.4. Coleridge SD, Amis AA. A comparison of five tibial-fixation systems in hamstringgraftanterior cruciate ligament reconstruction. Knee Surg Sports TraumatolArthrosc. 2004;12(5):391-397.5. Giurea M, Zorilla P, Amis AA, Aichroth P. Comparative pull-out and cyclic-loadingstrength tests of anchorage of hamstring tendon grafts in anterior cruciate ligamentreconstruction. Am J Sports Med. 1999;27(5):621-625.6. Greis PE, Burks RT, Bachus K, Luker MG. The influence of tendon length and fit on thestrength of a tendon-bone tunnel complex. A biomechanical and histologic study inthe dog. Am J Sports Med. 2001;29(4):493-497.7. Grover DM, Howell SM, Hull ML. Early tension loss in an anterior cruciate ligamentgraft. A cadaver study of four tibial fixation devices. J Bone Joint Surg Am.2005;87(2):381-390.8. Hamner DL, Brown CH, Jr., Steiner ME, Hecker AT, Hayes WC. Hamstring tendon graftsfor reconstruction of the anterior cruciate ligament: biomechanical evaluationof the use of multiple strands and tensioning techniques. J Bone Joint Surg Am.1999;81(4):549-557.9. Haut Donahue TL, Howell SM, Hull ML, Gregersen C. A biomechanical evaluationof anterior and posterior tibialis tendons as suitable single-loop anterior cruciateligament grafts. Arthroscopy. 2002;18(6):589-597.10. Howell SM, Taylor MA. Brace-free rehabilitation, with early return to activity, for kneesreconstructed with a double-looped semitendinosus and gracilis graft. J Bone JointSurg Am. 1996;78(6):814-825.11. Howell SM, Deutsch ML. Comparison of endoscopic and two-incision techniquesfor reconstructing a torn anterior cruciate ligament using hamstring tendons.Arthroscopy. 1999;15(6):594-606.12. Howell SM, Roos P, Hull ML. Compaction of a bone dowel in the tibial tunnelimproves the fixation stiffness of a soft tissue anterior cruciate ligament graft: an invitro study in calf tibia. Am J Sports Med. 2005;33(5):719-725.13. Karchin A, Hull ML, Howell SM. Tension in a double loop tendon anterior cruciategraft during a simulated open chain knee extension exercise. J Orthop Res.2005;23(1):77-83.14. Khan R, Konyves A, Rama KR, Thomas R, Amis AA. RSA can measure ACL graftstretching and migration: development of a new method. Clin Orthop Relat Res.2006;448:139-145.15. Kyung HS, Kim SY, Oh CW, Kim SJ. Tendon-to-bone tunnel healing in a rabbit model:the effect of periosteum augmentation at the tendon-to-bone interface. Knee SurgSports Traumatol Arthrosc. 2003;11(1):9-15.16. Liu-Barba D, Howell SM, Hull ML. High stiffness distal fixation restores anterior laxityand knee stiffness as well as joint line fixation with an interference screw. Am JSports Med. 2007:In Press.17. Magen HE, Howell SM, Hull ML. Structural properties of six tibial fixation methods foranterior cruciate ligament soft tissue grafts. Am J Sports Med. 1999;27(1):35-43.18. Matsumoto A, Howell SM, Liu-Barba D. Time-related changes in the cross-sectionalarea of the tibial tunnel after compaction of an autograft bone dowel alongside ahamstring graft. Arthroscopy. 2006;22(8):855-860.19. Pearsall AWt, Hollis JM, Russell GV, Jr., Scheer Z. A biomechanical comparison ofthree lower extremity tendons for ligamentous reconstruction about the knee.Arthroscopy. 2003;19(10):1091-1096.20. Roos PJ, Hull ML, Howell SM. Lengthening of double-looped tendon graft constructsin three regions after cyclic loading: a study using Roentgen stereophotogrammetricanalysis. J Orthop Res. 2004;22(4):839-846.21. Siegel MG, Barber-Westin SD. Arthroscopic-assisted outpatient anterior cruciateligament reconstruction using the semitendinosus and gracilis tendons.Arthroscopy. 1998;14(3):268-277.22. Singhatat W, Lawhorn KW, Howell SM, Hull ML. How four weeks of implantationaffect the strength and stiffness of a tendon graft in a bone tunnel: a studyof two fixation devices in an extraarticular model in ovine. Am J Sports Med.2002;30(4):506-513.23. Smith CK, Hull ML, Howell SM. Lengthening of a single-loop tibialis tendon graftconstruct after cyclic loading: a Study using Roentgen stereophotogrammetricanalysis. J Biomech Eng. 2006;128(3):437-442.24. Tomita F, Yasuda K, Mikami S, Sakai T, Yamazaki S, Tohyama H. Comparisons ofintraosseous graft healing between the doubled flexor tendon graft and thebone-patellar tendon-bone graft in anterior cruciate ligament reconstruction.Arthroscopy. 2001;17(5):461-476.25. Zacharias I, Howell SM, Hull ML, Lawhorn KW. In vivo calibration of a femoral fixationdevice transducer for measuring anterior cruciate ligament graft tension: a study inan ovine model. J Biomech Eng. 2001;123(4):355-361.

Package InsertBiomet Sports Medicine, Inc. 212820024861 E. Airport Dr. Rev. DOntario, CA 91761, USA Date: 02/07Biomet Sports Medicine Internal Fixation DevicesATTENTION OPERATING SURGEONDESCRIPTIONBiomet Sports Medicine manufactures a variety of internal fixation devices intended to aidin arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, dueto injury or degenerative disease. Implants used for this application include: screws, washers,anchors, pins, and suture. Specialty implants are available for specialized treatments.Materials316 LVM Stainless SteelTitanium AlloyUltra-High Molecular Weight Polyethylene (UHMWPE)PolyesterPolypropyleneINDICATIONSBone Mulch Screws are intended for use in fixation of semitendinous and/or gracile tendongrafts in ACL reconstruction only.Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bonegrafts in ACL reconstruction.Screw and Washers are indicated for soft tissue fixation to bone, and bone-to-bone fixation inorthopedic procedures specifically during Ligament reconstruction.Toggle anchors (i.e., ToggleLoc , ToggleLoc buttons and EZLoc ) are indicated for use forfixation of tendons and ligaments during orthopedic reconstruction procedures such as AnteriorCruciate Ligament (ACL) reconstruction.Patient selection factors to be considered include: 1) need for soft tissue to bone fixation, 2)ability and willingness of the patient to follow postoperative care instructions until healing iscomplete, and 3) a good nutritional state of the patient.CONTRAINDICATIONS1. Infection.2. Patient conditions including blood supply limitations, and insufficient quantity or quality ofbone or soft tissue.3. Patients with mental or neurologic conditions who are unwilling or incapable of followingpostoperative care instructions.4. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completedprior to implantation of the device.WARNINGSBiomet Sports Medicine internal fixation devices provide the surgeon with a means to aid in themanagement of soft tissue to bone reattachment procedures. While these devices are generallysuccessful in attaining these goals, they cannot be expected to replace normal healthy bone orwithstand the stress placed upon the device by full or partial weight bearing or load bearing,particularly in the presence of nonunion, delayed union, or incomplete healing. Therefore, it isimportant that immobilization (use of external support, walking aids, braces, etc.) of the treatmentsite be maintained until healing has occurred. Surgical implants are subject to repeated stressesin use, which can result in fracture or damage to the implant. Factors such as the patient’s weight,activity level, and adherence to weight bearing or load bearing instructions have an effect onthe service life of the implant. The surgeon must be thoroughly knowledgeable not only in themedical and surgical aspects of the implant, but also must be aware of the mechanical andmetallurgical aspects of the surgical implants.1. Correct selection of the implant is extremely important. The potential for success in softtissue to bone fixation is increased by the selection of the proper type of implant. Whileproper selection can help minimize risks, neither the device nor grafts, when used, are designedto withstand the unsupported stress of full weight bearing, load bearing or excessiveactivity.2. The implants can loosen or be damaged and the graft can fail when subjected to increasedloading associated with nonunion or delayed union. If healing is delayed, or does not occur,the implant or the procedure may fail. Loads produced by weight bearing and activitylevels may dictate the longevity of the implant.3. Inadequate fixation at the time of surgery can increase the risk of loosening and migrationof the device or tissue supported by the device. Sufficient bone quantity and quality are importantto adequate fixation and success of the procedure. Bone quality must be assessedat the time of surgery. Adequate fixation in diseased bone may be more difficult. Patientswith poor quality bone, such as osteoporotic bone, are at greater risk of device looseningand procedure failure.4. Implant materials are subject to corrosion. Implanting metals and alloys subjects them toconstant changing environments of salts, acids, and alkalis that can cause corrosion. Puttingdissimilar metals and alloys in contact with each other can accelerate the corrosion processthat may enhance fracture of implants. Every effort should be made to use compatible metalsand alloys when marrying them to a common goal, i.e., screws and plates.5. Care is to be taken to insure adequate soft tissue fixation at the time of surgery. Failure toachieve adequate fixation or improper positioning or placement of the device can contributeto a subsequent undesirable result.6. The use of appropriate immobilization and postoperative management is indicated as partof the treatment until healing has occurred.7. Correct handling of implants is extremely important. Do not modify implants. Do notnotch or bend implants. Notches or scratches put in the implant during the course ofsurgery may contribute to breakage. Intraoperative fracture of screws can occur if excessiveforce (torque) is applied while seating bone screws.8. Do not use excessive force when inserting suture anchors. Excessive force (e.g., long, hardhammer blows) may cause fracture or bending of the device. Prior to insertion of theimplant, predrill, awl, or tap.9. DO NOT USE if there is a loss of sterility of the device.10. Discard and DO NOT USE opened or damaged devices, and use only devices that are packagein unopened or undamaged containers.11. Ensure contact of tissue to bone when implanting. DO NOT OVERTIGHTEN the screw. Structuraldamage to the tissue and implant may occur if the screw is overtightened.12. Adequately instruct the patient. Postoperative care is important. The patient’s ability andwillingness to follow instructions is one of the most important aspects of successful fracturemanagement. Patients effected with senility, mental illness, alcoholism, and drug abuse maybe at a higher risk of device or procedure failure. These patients may ignore instructionsand activity restrictions. The patient is to be instructed in the use of external supports, walkingaids, and braces that are intended to immobilize the fracture site and limit weight bearingor load bearing. The patient is to be made fully aware and warned that the device doesnot replace normal healthy bone, and that the device can break, bend or be damaged asa result of stress, activity, load bearing, or weight bearing. The patient is to be made awareand warned of general surgical risks, possible adverse effects, and to follow the instructionsof the treating physician. The patient is to be advised of the need for regular postoperativefollow-up examinations as long as the device remains implanted.13. The ToggleLoc Buttons are used with a size #2 polyester suture or one of equivalent orgreater strength, unless otherwise indicated.PRECAUTIONSDo not reuse implants. While an implant may appear undamaged, previous stress may havecreated imperfections that would reduce the service life of the implant. Do not treat withimplants that have been, even momentarily, placed in a different patient.Instruments are available to aid in the accurate implantation of internal fixation devices.Intraoperative fracture or breaking of instruments has been reported. Surgical instrumentsare subject to wear with normal usage. Instruments, which have experienced extensive use orexcessive force, are susceptible to fracture. Surgical instruments should only be used for theirintended purpose. Biomet Sports Medicine recommends that all instruments be regularlyinspected for wear and disfigurement.If device contains MaxBraid suture, refer to manufacturer package insert for furtherinformation.POSSIBLE ADVERSE EFFECTS1. Nonunion or delayed union, which may lead to breakage of the implant.2. Bending or fracture of the implant.3. Loosening or migration of the implant.4. Metal sensitivity, or allergic reaction to a foreign body.5. Pain, discomfort, or abnormal sensation due to the presence of the device.6. Nerve damage due to surgical trauma.7. Necrosis of bone or tissue.8. Inadequate healing.9. Intraoperative or postoperative bone fracture and/or postoperative pain.STERILITYBiomet Sports Medicine internal fixation implants are supplied sterile and are sterilized byexposure to a minimum dose of 25kGy of gamma radiation or by Ethylene Oxide Gas (ETO) ifdevice contains MaxBraid PE suture. Do not resterilize.Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.Authorized Representative: Biomet U.K., Ltd.Waterton Industrial Estates,Bridgend, South WalesCF31 3XA, U. K.0086The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised afterthat date. To obtain a current package insert, please contact Biomet Sports Medicine at the contact information provided herein.

Ordering InformationWasherLoc Tibial FixationWasherLoc Tibial Fixation Device908469 16mm Extended Spike908468 18mm Extended SpikeWasherLoc Cortical Screw908624 24mm908626 26mm908628 28mm908630 30mm908632 32mm908634 34mm908636 36mm908638 38mm908640 40mm908642 42mm908644 44mm908646 46mm908648 48mm908650 50mm908652 52mm908654 54mm908656 56mm908658 58mm908660 60mmWasherLoc Cancellous Screw908824 24mm908826 26mm908828 28mm908830 30mm908832 32mm908834 34mm908836 36mm908838 38mm908840 40mm908842 42mm908844 44mm908846 46mm908848 48mm908850 50mm908852 52mm908854 54mm908856 56mm908858 58mm908860 60mmBone Dowel HarvesterHarvesting Tubes (Disposable)900737 7mm900738 8mm900739 9mm900740 10mm900741 11mmThis material is intended for the Biomet Sports Medicine Sales Force and surgeons only.It is not intended to be redistributed without the express written consent of Biomet Sports Medicine.EZLoc, Howell, MaxBraid and WasherLoc are trademarks of Biomet Sports Medicine, Inc.P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501 • ©2007 Biomet Sports Medicine, Inc. All Rights ReservedBSM0129.0 REV123107www.biometsportsmedicine.com