. Soft Tissue Regeneration... Consultant. RTI Surgical...Consultant. OSSUR...Consultant. Arthrex...Consultant

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1 sl23lls 1 E ACL Graft Choice in the Elite Athlete and When Do I Let Them Return to Sport: Graft Ghoice: Allografts Peter A. lndelicato MD Emeritus Professor Sports Medicine Department of OrthoPaedic Surgery University of Florida Disclosures.... Soft Tissue Regeneration... Consultant. RTI Surgical....Consultant. OSSUR....Consultant. Arthrex...Consultant Understanding Key Words.... "Aseptic Processing" does not mean "sterile"...it only means that no further bio-contamination occurs during the harvesting/packaging process.... Any bacteria/spores/viruses that exist inside tissue prior to donor death or immediate post-mortem remain and are not eliminated by "aseptic processing",i [[l Why! favor allografts...simply Stated.... Non-irradiated "anatomically" placed allograft tissue works, I believe, in a acceptable number of patients assuming they participate in a well-controlled rehabilitation program.... ln other words, they have the same Ievel of success as autografts without the morbidity associated with graft harvest.... Specifically.... A non-irradiated posterior tibialis tendon because patienu graft mismatch length is never a problem and biomechanically it's similar to native ACL...

2 sl23/ls ; E Why no lrradiation???, [E.l Facts about lrradiation. (1) More than 4 Mrads required to kill all spores and viruses. "Gamma irradiation on HIV-1". Journal of Orthopedic Research Smith, et al. "These data suggests that gamma irradiation ( Mrads ) does not constitute a virucidal dose to HIV' Facts about irradiation. (2) Even small doses ( exposure ) has effect on the biomechanical properties of tissue. "Biomechanics of gamma-irradiation vs non-irradiated human tendon". Pittsburgh Orthopedic Journal "2.5 Mrad commonly used in processing allograft tissue, causes a 4.73o/o and o/o reduction in stiffness and maximum strength, eeos. AAOS Committee on Biological lmplants Tissue Work Group: "Less than 1 Mrad may effect the mechanical properties of soft tissue" io E Surgeon's Dilemma!!!... TOO MUCH irradiation (above 2.5 Mrad) negatively effects the biomechanical properties...too Little allows most spores and viruses to survive!!! i r E Facts about irradiation. (3) lrradiation Effects Allograft Outcomes. "Non-irradiated vs irradiated Achilles allograft: in vivo comparison" 2

3 sl23/ls 178 ffi Rappe, lndelicato, et al AJSM 2OO7 The non-irradiated group had2.4o/o failure rate vs 34o/o failure rate in irradiated group Average exposure was 2.5 Mrads o ( ACL reconstruction with BPTB autograft, irradiated vs non-irradiated allograft: a prospective randomized study." Knee Surgery and Sports Traumatology and Arthroscopy" 2009 Sun, et al. Failure rate of ACL reconstruction with irradiated allograft (34.4%) is higher than that of autograft (6.1%) and nonirradiated allograft (8.8%) Facts about irradiation (4) lrradiation may not be good... even is doses below 2.5 Mrads "Current Concepts: analysis of irradiation on clinical effectiveness of allogenic tissue for primary ACL AJSM 2015 Jan 43: Palmer, Dwyer, et a!... Conclusion: "These results suggest that primary ACLR's using non-irradiated allografts may provide superior clinical outcomes than those using low dose (<2.5 Mrads) irradiated grafts... [t]] Facts about irradiation (5) Fresh Frozen ( non-irradiated ) grafts seem to perform as good as autografts... "The effects of graft tissue on ACL outcomes: a multi center, prospective, randomized control trial comparing autograft hamstrings with fresh-frozen (non-irradiated) anterior tibialis allograft" Arthroscopy,

4 s/23/ls. Lawhorn, et al fnl Results.... No significant difference were found between autografts (hamstrings) and non-irradiated allografts (anterior tibialis) rc fnl Facts about irradiation. (5) Fresh Frozen ( non-irradiated ) grafts seem to perform as good as autografts.... "Arthroscopic reconstruction of the ACL with hamstring autografts and fresh trozen allografts: a prospective randomized controlled study". AJSM, March: Sun, et al 178 r8e. Level 2 Study. 91 patients auto vs 96 patients allografts. All allografts were non-irradiated. One surgeon...ave age both groups % sports related injuries. Conclusion: Both groups of patients achieved same satisfactory outcome at an average follow up of 7.8 years. "Autograft vs. non-irradiated allograft tissue for ACL reconstruction... systematic review'. AJSM March, Mariscalco, Kaeding, et al. Conclusion: "No significant differences were found in graft failure rate, postoperative laxity, or patient reported outcome scores when comparing ACLR with autograft to non-irradiated allografts in this systematic review" 4

5 , s/23/ls it m What about allograft success in young patients? a a ANS: Maybe not that bad!!! "Failure rate of achilles tendon allograft in primary ACL Arthroscopy, 2010 Shah, Lowe, et al Failure Rate:. 5.60/o... Overall. 8.8o/o... under 25ylo. 5.7o/o ylo. 0o/o...over 40ylo lffi t-r Facts: (6) Allograft tissue appears to take longer to go thru the "ligamentization" process compared to autograft tissue... University of Florida....Histological Comparison....Unpublished Data (1 996) E ZS patients in each group (auto vs allo) biopsied at comparable points in time.. 22 E Therefore.... The rehabilitation program should account for this slower "ligamentization" process and retum to high risk sports should be delayed...!!!!! ffi Return to Sport. Although there is not good data yet available, I believe that following allograft ACL reconstruction, return to high risk sports should be delayed at least months...despite how "good" an athlete's knee may feel!!!! [t].l conclusion Both the basic science and clinical literature supports the continued use of non-irradiated allograft tissue as an acceptable option in performing ACL reconstruction of the knee

6 sl23/ls :58. Allografts are safe, have less morbidity compared to autografts and have comparable outcomes when one critically reviews the data and applies an appropriate delayed rehab program... Question: ACL Graft Choice in the Elite Athlete: when do I let them return to sport??? r.::::) - Lr --rt tt t rences:."non-irradiated vs irradiated Achilles allograft: in vivo comparison".rappe, lndelicato...ajsm, 2007."ACL reconstruction with BTB autograft,irradiated vs nonirradiated allograft: a prospective randomized study".kang, et a... KSSTA, 2009."Biomechanics of gamma-irradiated vs non-irradiated human tissue".pittsburgh Orthopedic Journal, 2009."Gamma irradiation on HIV-1".Smith, et al... Journal of Orthopedic Research, 2001."Current Concepts: analysis of irradiation on clinical effectiveness of allogenic tissue for primary ACL.Palmer, Dwyer, et al...ajsm, 2015."The effects of graft tissue on ACL outcomes: a multi center, prospective, randomized control trial comparing autograft hamstrings with fresh-frozen anterior tibias allograft".lawhorn, et al...athroscopy, 2012."Autograft vs. non-irradiated allograft tissue for ACL reconstruction : a systematic review".mariscalco, Kaeding..AJSM, 2013."Failure rate of achilles tendon allograft in primary ACL.Shah, Lowe..Arthroscopy,