Failure Rates & Functional Outcomes

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1 Failure Rates & Functional Outcomes Allograft/Autograft BPTB ACL Reconstruction In Patients <30 Years of Age Kevin D. Plancher, MD, MPH Clinical Professor Albert Einstein College of Medicine New York, New York 12th Biennial ISAKOS Congress May 12-16, 2019 Cancun, Mexico Stephanie C. Petterson, MPT, PhD Director of Research Eric J. West Orthopaedic Foundation Stamford, CT

2 Disclosures May 2019 No relevant financial disclosures.

3 What We Thought We Knew? Meta-Analyses Are Inconclusive - Functional Outcomes Allograft Worse Functional Outcomes Autograft & Allograft Equal Functional Outcomes Kan 2016 Bottoni 2015 Irradiated Allograft Jia 2015 Zeng 2016 Mascarenhas 2015 Irradiated Allograft Wasserstein 2015 Yao 2015 Kan 2016 Nonirradiated Allograft Functional Questionnaires or Sport Tests Kane 2016 Zeng 2016 Nonirradiated Allograft Yang 2017 Wang Wasserstein D et al. A systematic review of failed ACLR with autograft compared with allograft in young patients. Sports Health. 2015; Bottoni CR1, Smith EL2, Shaha J3, Shaha SS4, Raybin SG3, Tokish JM3, Rowles DJ3. Autograft Versus Allograft ACLR: A Prospective, Randomized Clinical Study With a Minimum 10-Year Follow-up. Am J Sports Med Oct;43(10): Mascarenhas R, Erickson BJ, Sayegh ET, Verma NN, Cole BJ, Bush-Joseph C, Bach BR Jr. Is there a higher failure rate of allografts compared with autografts in anterior cruciate ligament reconstruction: a systematic review of overlapping meta-analyses. Arthroscopy Feb;31(2): Zeng C, Gao SG, Li H, Yang T, Luo W, Li YS, Lei GH. Autograft Versus Allograft in ACLR: A Metaanalysis of Randomized Controlled Trials and Systematic Review of Overlapping Systematic Reviews. Arthroscopy Jan;32(1): e18 5.Kan SL, Yuan ZF, Ning GZ, Yang B, Li HL, Sun JC, Feng SQ. Autograft versus allograft in ACLR: A meta-analysis with trial sequential analysis. Medicine (Baltimore) Sep;95(38):e Kane PW, Wascher J, Dodson CC, Hammoud S, Cohen SB, Ciccotti MG. ACLR with bone-patellar tendon-bone autograft versus allograft in skeletally mature patients aged 25 years or younger. KSSTA Nov;24(11): Wang HD, Zhu YB, Wang TR, Zhang WF, Zhang YZ. Irradiated allograft versus autograft for ACLR: A meta-analysis and systematic review of prospective studies. Int J Surg Jan;49: Yao LW1, Wang Q, Zhang L, Zhang C, Zhang B, Zhang YJ, Feng SQ. Patellar tendon autograft versus patellar tendon allograft in ACLR: a systematic review and meta-analysis. Eur J Orthop Surg Traumatol Feb;25(2): Yang R, Deng H, Hou J, Ouyang Y, Chen Z, Song B, Zhou Y, Tan W, Li W, Shen H. Comparison of Knee Stability and Synovial Fluid Alterations in ACLR With a Hamstring Autograft or an Allograft. Orthopedics Sep 1;40(5):e892-e Jia YH, Sun PF1. Comparison of Clinical Outcome of Autograft and Allograft Reconstruction for Anterior Cruciate Ligament Tears. Chin Med J (Engl) Dec 5;128(23): doi: /

4 What We Thought We Knew? Meta-Analyses Are Inconclusive - Laxity Allograft Increased Knee Laxity Autograft & Allograft Equal Knee Laxity Kan 2016 Jia 2015 Irradiated Allograft Yao 2015 Zeng 2016 Kan 2016 Irradiated Allograft Yang 2017 Wang 2018 Nonirradiated Allograft 1.Zeng C, Gao SG, Li H, Yang T, Luo W, Li YS, Lei GH. Autograft Versus Allograft in ACLR: A Meta-analysis of Randomized Controlled Trials and Systematic Review of Overlapping Systematic Reviews. Arthroscopy Jan;32(1): e18 2.Kan SL, Yuan ZF, Ning GZ, Yang B, Li HL, Sun JC, Feng SQ. Autograft versus allograft in anterior cruciate ligament reconstruction: A meta-analysis with trial sequential analysis. Medicine (Baltimore) Sep;95(38):e Wang HD, Zhu YB, Wang TR, Zhang WF, Zhang YZ. Irradiated allograft versus autograft for anterior cruciate ligament reconstruction: A meta-analysis and systematic review of prospective studies. Int J Surg Jan;49: Yang R, Deng H, Hou J, Ouyang Y, Chen Z, Song B, Zhou Y, Tan W, Li W, Shen H. Comparison of Knee Stability and Synovial Fluid Alterations in Anterior Cruciate Ligament Reconstruction With a Hamstring Autograft or an Allograft. Orthopedics Sep 1;40(5):e892-e Yao LW1, Wang Q, Zhang L, Zhang C, Zhang B, Zhang YJ, Feng SQ. Patellar tendon autograft versus patellar tendon allograft in anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Eur J Orthop Surg Traumatol Feb;25(2): Jia YH, Sun PF1. Comparison of Clinical Outcome of Autograft and Allograft Reconstruction for Anterior Cruciate Ligament Tears. Chin Med J (Engl) Dec 5;128(23): doi: /

5 What We Thought We Knew? Meta-Analyses Are Inconclusive - Re-Rupture Rate Allograft Increased Re-Rupture Rate Autograft & Allograft Equal Re-Rupture Rate Bottoni 2015 Mascarenhas 2015 Kaeding 2011,2015 Kan 2016 Yao 2015 Didn t Control for Multiple Comparisons Zeng 2016 Kan 2016 Yang 2017 Irradiated Allograft Weng 2018 Zeng 2016 Irradiated Allograft Kane 2016 Wasserstein 2016 Maletis 2017 Riff 2017 Nonirradiated Allograft Nonirradiated Allograft 1.Kaeding CC et al. Allograft Versus Autograft ACL Reconstruction: Predictors of Failure From a MOON Prospective Longitudinal Cohort. Sports Health (1): Maletis GB et al. Reconstruction of the ACL: association of graft choice with increased risk of early revision. Bone Joint J B(5): Wasserstein D et al. A systematic review of failed ACLR with autograft compared with allograft in young patients. Sports Health. 2015; Bottoni CR1, Smith EL2, Shaha J3, Shaha SS4, Raybin SG3, Tokish JM3, Rowles DJ3. Autograft Versus Allograft ACLR: A Prospective, Randomized Clinical Study With a Minimum 10-Year Follow-up. Am J Sports Med Oct;43(10): Mascarenhas R, Erickson BJ, Sayegh ET, Verma NN, Cole BJ, Bush-Joseph C, Bach BR Jr. Is there a higher failure rate of allografts compared with autografts in ACLR a systematic review of overlapping meta-analyses. Arthroscopy Feb;31(2): Yang R, Deng H, Hou J, Ouyang Y, Chen Z, Song B, Zhou Y, Tan W, Li W, Shen H. Comparison of Knee Stability and Synovial Fluid Alterations in ACLR With a Hamstring Autograft or an Allograft. Orthopedics Sep 1;40(5):e892-e Zeng C, Gao SG, Li H, Yang T, Luo W, Li YS, Lei GH. Autograft Versus Allograft in ACLR: A Meta-analysis of Randomized Controlled Trials and Systematic Review of Overlapping Systematic Reviews. Arthroscopy Jan;32(1): e18 8.Kan SL, Yuan ZF, Ning GZ, Yang B, Li HL, Sun JC, Feng SQ. Autograft versus allograft in ACLR: A meta-analysis with trial sequential analysis. Medicine (Baltimore) Sep;95(38):e Kane PW, Wascher J, Dodson CC, Hammoud S, Cohen SB, Ciccotti MG. ACLR with bone-patellar tendon-bone autograft versus allograft in skeletally mature patients aged 25 years or younger. KSSTA Nov;24(11): Wasserstein D et al. A systematic review of failed ACLR with autograft compared with allograft in young patients. Sports Health. 2015; Riff AJ, Luchetti TJ, Weber AE, Chahal J, Bach BR Jr. Thirty-Year Experience With ACL Reconstruction Using Patellar Tendon: A Critical Evaluation of Revision and Reoperation. Orthop J Sports Med Aug 29;5(8): Yao LW1, Wang Q, Zhang L, Zhang C, Zhang B, Zhang YJ, Feng SQ. Patellar tendon autograft versus patellar tendon allograft in anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Eur J Orthop Surg Traumatol Feb;25(2): Wang HD, Zhu YB, Wang TR, Zhang WF, Zhang YZ. Irradiated allograft versus autograft for ACLR: A meta-analysis and systematic review of prospective studies. Int J Surg Jan;49:45-55.

6 What We Now Really Know The Big Question Our Purpose Investigate Differences in Clinical Outcomes in Our Series vs Allograft Reconstruction Patients >17 and <30 Years Do We Really Know the Answer Today?

7 Methodology Inclusion/Exclusion Criteria Cohort Study - Single Surgeon (KDP) ACL Reconstruction ( ) Follow-Up >2 Years (Range Years) Autograft BPTB - 35 Patients Allograft BPTB - 13 Patients LifeNet (Virginia Beach, VA, USA)/ MTF (Edison, NJ, USA) Exclusion Criteria Age - Patients <16 Years & >31 Years Revision Surgery Osteochondral Grafting Multiligamentous Injuries Outcome Questionnaires Lysholm, IKDC, Tegner Physical Examination Range of Motion Ligamentous Testing Lachman/Pivot Shift KT1000 Arthrometer 15 lbs, 20 lbs, 30 lbs, Manual Max Pre/Post Op Imaging Plain Radiographs, MRI, CT Scan

8 Surgical Technique Transtibial with Anteromedial Portal Patella Tendon Autograft (10mm Tendon) Cancellous Bone Graft 1/3 Thickness Closure Allograft Source* <40 Years of Age (14mm Tendon) 5 Years Younger Than Patient Age Bioabsorbable Interference Screw (Linvatec, Largo, FL) Poly L-lactic acid Femur 8x20 Tibia 9x20 or 9x25 Meniscal Repair All-Inside - Smith/Nephew Inside-Out - Linvatec Zone Specific Cannula McGuire DA et al. Bioabsorbable interference screws for graft fixation in anterior cruciate ligament reconstruction. Arthroscopy Jul-Aug;15(5):

9 Postoperative Rehabilitation Protocol All Patients Conservative Decelerated Rehab Program Bone Tunnel Enlargement Avoided Increased Seen With Accelerated, Brace Free, Rehab in Hamstring Autograft ACLR 1-2 CPM for Home Weeks- No Evidence Cryotherapy 3 - Evidence Confirmed Brace Utilized-No Evidence Post Op Knee Brace 6 Weeks Locked ACL Sport Specific Brace Weeks Post Op Supervised Physical Therapy 4-5 Brace Wear at 5 Months Allograft and Autograft Cutting/Pivoting Sports Adequate Proprioception Never Less Than 6 Months 7 Sport Test - Return to Sport 6 5 Months Status Post ACLR Interstitial Revascularization 1. Shelbourne KD, Nitz P. Accelerated rehabilitation after ACLR. JOSPT; 1992;15(6): Vadalà A, Iorio R, De Carli A, Argento G, Di Sanzo V, Conteduca F, Ferretti A. The effect of accelerated, brace free, rehabilitation on bone tunnel enlargement after ACLR using hamstring tendons: a CT study. KSST Apr;15(4): Gatewood CT, Tran AA, Dragoo JL. The efficacy of post-operative devices following knee arthroscopic surgery: a systematic review. KSSTA Feb;25(2): Han F, Banerjee A, Shen L, Krishna L. Increased Compliance With Supervised Rehabilitation Improves Functional Outcome & Return to Sport ACLR in Recreational Athletes. OJSM Dec 10;3(12): Christensen JC, Miller CJ, Burns RD, West HS. Effect of Physical Therapy Visits on Clinical Outcomes Following Anterior Cruciate Ligament Reconstruction With and Without Concurrent Meniscal Repair. J Sport Rehabil Aug 8: Menzer H, Slater LV, Diduch D, Miller M, Norte G, Goetschius J, Hart JM. The Utility of Objective Strength and Functional Performance to Predict Subjective Outcomes After ACLR. OJSM Dec 18;5(12): Grindem H, Snyder-Mackler L, Moksnes H, Engebretsen L, Risberg MA. Simple decision rules can reduce reinjury risk by 84% after ACLR: the Delaware-Oslo ACL cohort study. Br J Sports Med Jul;50(13): Lowe WR1, Warth RJ, Davis EP, Bailey L. Functional Bracing After Anterior Cruciate Ligament Reconstruction: A Systematic Review. JAAOS Mar;25(3): doi: /JAAOS-D

10 Definition and Results Graft Rupture/ Functional Performance Age at Surgery - Comparable (p=0.187) Autograft ±4.4 yrs Allograft ±3.9 yrs Follow-Up Comparable (p=0.155) Autograft - 8.7±5.2 yrs Allograft - 6.7±3.7 yrs Overall Failure Rate 2.1% (N=1) Allograft - 0% Autograft - 2.9% (N=1) 4 Years Post Op Revision By Another Surgeon Young Female-Ski Trauma 15 Years Ago No Significant Difference Between Allograft/Autograft (p=0.324) No Difference in Clinical Outcomes Lysholm (p=0.380) IKDC (p=0.324) Tegner (p=0.365) Success Rate Autograft, 97.1% Failure Rate Allograft, 0% Functional Score Failure Rate Autograft, 2.9% Success Rate Allograft, 100% Overall Success/Rupture Rate BPTB Allo BPTB Auto Post-Op Lysholm BPTB Allo BPTB Auto Post-Op IKDC

11 Outcomes Return to Sport - Contact & NonContact All Patients Returned to Preop Sport Level Tegner >6 (Range 6-10) Allograft Contact Sports Soccer - 31% Basketball - 8% Lacrosse - 8% Limited/Non Contact Sports Skiing/Snowboarding - 38% Running - 23% Gymnastics - 8% Baseball/Softball - 31% Autograft Contact Sports Soccer - 9% Basketball - 23% Lacrosse - 16% Football - 14% Limited/Non Contact Sports Skiing/Snowboarding - 17% Running - 11% Gymnastics - 2% Baseball/Softball - 23% Tennis - 11%

12 No Significant Difference AUTOGraft vs. ALLOGraft Significance p<0.05 KT Lbs p=0.997 Manual Maximum p=0.747 Side-to-Side Difference 30 lbs p=0.402 Manual Max p= Pivot Shift Negative Auto N=33 Allo N=10 Positive Glide Auto N=2 Allo N=1 Positive Clunk Auto N=0 Allo N=2 Lachman Negative Auto N=34 Allo N=10 Nearly Normal (3-5mm) Auto N=1 Allo N=2 Abnormal (6-10mm) Auto N=0 Allo N=1 Outcomes Laxity KT1000 Arthrometer Testing (mm) Side-to-Side Difference KT1000 (mm) Pre Un 30 Post Un 30 Pre Un Max Post Un Max Pre In 30 Post In 30 Pre In Max Pre Diff 30 Post Diff 30 Pre Diff Max Post Diff Max Pre In Max

13 Summary Conclusions - Mid-Term Results Allograft BPTB ACLR Excellent Option in Patients <30 Years Old Equal Results Compared to Autograft ACLR Complications Not Seen No Infections/Osteolysis No Laxity No Arthritis Seen Yet Long Term Return to Sporting Activities Anatomical Restoration Graft Matters Non-Irradiated or <2.2 Mrad Allograft Age <40 Years Always 5 Years Less Than Patient Age 1.Kan SL1, Yuan ZF, Ning GZ, Yang B, Li HL, Sun JC, Feng SQ. Autograft versus allograft in anterior cruciate ligament reconstruction: A meta-analysis with trial sequential analysis. Medicine (Baltimore) Sep;95(38):e Zeng C1, Gao SG1, Li H1, Yang T1, Luo W1, Li YS1, Lei GH2. Autograft Versus Allograft in Anterior Cruciate Ligament Reconstruction: A Meta-analysis of Randomized Controlled Trials and Systematic Review of Overlapping Systematic Reviews. Arthroscopy Jan;32(1): e18.

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