Progress of sterilization and preservation methods for allografts in anterior cruciate ligament reconstruction_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

SHANG Xiaoke ¹ , WANG Huihui ² , LI Jian ² ,  LI Qi ²

1. Department of Orthopedics, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan Ningxia, 750000, P.R.China;
2. Sports Medicine Center of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China;

Corresponding author：

LI Qi, Email: liqimm@163.com

Keywords：

Anterior cruciate ligament reconstruction; allograft; sterilization; preservation

DOI：

10.7507/1002-1892.201903078

Video：

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Objective To review the current status and progress of sterilization and preservation for allograft in anterior cruciate ligament reconstruction.Methods The related literature about the sterilization and preservation of allografts in anterior cruciate ligament reconstruction was extensively reviewed and summarized.Results There are many sterilization methods for allografts, the most commonly used method is γ-ray irradiation, but the optimal irradiation dose is still unclear. Electron beam irradiation is also available, but excessive dose is harmful to graft shaping. A combined sterilization method combining physics and chemistry methods is still being explored. Cryopreservation is the most commonly used method of preservation. In order to reduce the influence of crystals, the principle of " slow cooling and rapid rewarming” should be adhered to as far as possible.Conclusion The processing methods of allograft can affect the effectiveness of anterior cruciate ligament reconstruction. The clinical doctors should consider the sterilization and preservation methods in practice.

Citation： SHANG Xiaoke, WANG Huihui, LI Jian, LI Qi. Progress of sterilization and preservation methods for allografts in anterior cruciate ligament reconstruction. Chinese Journal of Reparative and Reconstructive Surgery, 2019, 33(9): 1102-1107. doi: 10.7507/1002-1892.201903078 Copy

1.	Gans I, Retzky JS, Jones LC, et al. Epidemiology of recurrent anterior cruciate ligament injuries in National Collegiate Athletic Association Sports: The Injury Surveillance Program, 2004-2014. Orthop J Sports Med, 2018, 6(6): 1-7.
2.	Mehran N, Moutzouros VB, Bedi A. A review of current graft pptions for anterior cruciate ligament reconstruction. JBJS Rev, 2015, 3(11): 1-2.
3.	韩啸, 蒋青. 前交叉韧带重建三种移植物中长期临床效果对比研究进展. 中国运动医学杂志, 2018, 37(10): 886-890.
4.	Wang HD, Zhu YB, Wang TR, et al. Irradiated allograft versus autograft for anterior cruciate ligament reconstruction: A meta-analysis and systematic review of prospective studies. Int J Surg, 2018, 49: 45-55.
5.	Roberson TA, Abildgaard JT, Wyland DJ, et al. " Proprietary processed” allografts: clinical outcomes and biomechanical properties in anterior cruciate ligament reconstruction. Am J Sports Med, 2017, 45(13): 3158-3167.
6.	Díaz-de-Rada P, Barriga A, Barroso JL, et al. Positive culture in allograft ACL-reconstruction: what to do? Knee Surg Sports Traumatol Arthrosc, 2003, 11(4): 219-222.
7.	Tomford WW. Transmission of disease through transplantation of musculoskeletal allografts. J Bone Joint Surg (Am), 1995, 77(11): 1742-1754.
8.	Asselmeier MA, Caspari RB, Bottenfield S. A review of allograft processing and sterilization techniques and their role in transmission of the human immunodeficiency virus. Am J Sports Med, 1993, 21(2): 170-175.
9.	Cohen SB, Sekiya JK. Allograft safety in anterior cruciate ligament reconstruction. Clin Sports Med, 2007, 26(4): 597-605.
10.	Whitlock PW, Seyler TM, Parks GD, et al. A novel process for optimizing musculoskeletal allograft tissue to improve safety, ultrastructural properties, and cell infiltration. J Bone Joint Surg (Am), 2012, 94(16): 1458-1467.
11.	赵彦涛, 刘思扬, 尹惠琼, 等. γ 射线终末辐照对同种异体肌腱病毒灭活效果及生物力学性能影响的研究. 中国骨与关节杂志, 2018, 7(5): 389-393.
12.	Lansdown DA, Riff AJ, Meadows M, et al. What factors influence the biomechanical properties of allograft tissue for ACL reconstruction? A systematic review. Clin Orthop Relat Res, 2017, 475(10): 2412-2426.
13.	Yanke AB, Bell R, Lee A, et al. The biomechanical effects of 1. 0 to 1. 2 Mrad of γ irradiation on human bone-patellar tendon-bone allografts. Am J Sports Med, 2013, 41(4): 835-840.
14.	Fideler BM, Vangsness CT Jr, Lu B, et al. Gamma irradiation: effects on biomechanical properties of human bone-patellar tendon-bone allografts. Am J Sports Med, 1995, 23(5): 643-646.
15.	Greaves LL, Hecker AT, Brown CH Jr. The effect of donor age and low-dose gamma irradiation on the initial biomechanical properties of human tibialis tendon allografts. Am J Sports Med, 2008, 36(7): 1358-1366.
16.	Hamer AJ, Stockley I, Elson RA. Changes in allograft bone irradiated at different temperatures. J Bone Joint Surg (Br), 1999, 81(2): 342-344.
17.	Balsly CR, Cotter AT, Williams LA, et al. Effect of low dose and moderate dose gamma irradiation on the mechanical properties of bone and soft tissue allografts. Cell Tissue Bank, 2008, 9(4): 289-298.
18.	Zhou M, Zhang N, Liu X, et al. Tendon allograft sterilized by peracetic acid/ethanol combined with gamma irradiation. J Orthop Sci, 2014, 19(4): 627-636.
19.	Seto AU, Gatt CJ, Dunn MG. Sterilization of tendon allografts: a method to improve strength and stability after exposure to 50 kGy gamma radiation. Cell Tissue Bank, 2013, 14(3): 349-357.
20.	Ng KW, Wanivenhaus F, Chen T, et al. Differential cross-linking and radio-protective effects of genipin on mature bovine and human patella tendons. Cell Tissue Bank, 2013, 14(1): 21-32.
21.	Schmidt T, Hoburg A, Broziat C, et al. Sterilization with electron beam irradiation influences the biomechanical properties and the early remodeling of tendon allografts for reconstruction of the anterior cruciate ligament (ACL). Cell Tissue Bank, 2012, 13(3): 387-400.
22.	Hoburg AT, Keshlaf S, Schmidt T, et al. Effect of electron beam irradiation on biomechanical properties of patellar tendon allografts in anterior cruciate ligament reconstruction. Am J Sports Med, 2010, 38(6): 1134-1140.
23.	Hashemi S, Gholamhosseinpour A, Niakousari M. Application of microwave and ohmic heating for pasteurization of cantaloupe juice: Microbial inactivation and chemical properties. J Sci Food Agric, 2019, 99(9): 20-25.
24.	Proffen BL, Perrone GS, Fleming BC, et al. Effect of low-temperature ethylene oxide and electron beam sterilization on the in vitro and in vivo function of reconstituted extracellular matrix-derived scaffolds. J Biomater Appl, 2015, 30(4): 435-449.
25.	Almeida OM, Jorgetti W, Oksman D, et al. Comparative study and histomorphometric analysis of bone allografts lyophilized and sterilized by autoclaving, gamma irradiation and ethylene oxide in rats. Acta Cir Bras, 2013, 28(1): 66-71.
26.	Drez DJ, DeLee J, Holden JP, et al. Anterior cruciate ligament reconstruction using bone-patellar tendon-bone allografts. A biological and biomechanical evaluation in goats. Am J Sports Med, 1991, 19(3): 256-263.
27.	Scheffler S, Trautmann S, Smith M, et al. No influence of collagenous proteins of Achilles tendon, skin and cartilage on the virus-inactivating efficacy of peracetic acid-ethanol. Biologicals, 2007, 35(4): 355-359.
28.	Maletis GB, Chen J, Inacio M, et al. Increased risk of revision after anterior cruciate ligament reconstruction with soft tissue allografts compared with autografts: graft processing and time make a difference. Am J Sports Med, 2017, 45(8): 1837-1844.
29.	Tejwani SG, Chen J, Funahashi TT, et al. Revision risk after allograft anterior cruciate ligament reconstruction: association with graft processing techniques, patient characteristics, and graft type. Am J Sports Med, 2015, 43(11): 2696-2705.
30.	Schimizzi A, Wedemeyer M, Odell T, et al. Effects of a novel sterilization process on soft tissue mechanical properties for anterior cruciate ligament allografts. Am J Sports Med, 2007, 35(4): 612-616.
31.	Phipps A, Vaynshteyn E, Kowalski JB, et al. Chemical sterilization of allograft dermal tissues. Cell Tissue Bank, 2017, 18(4): 573-584.
32.	Park SS, Dwyer T, Congiusta F, et al. Analysis of irradiation on the clinical effectiveness of allogenic tissue when used for primary anterior cruciate ligament reconstruction. Am J Sports Med, 2015, 43(1): 226-235.
33.	Bui D, Lovric V, Oliver R, et al. Meniscal allograft sterilisation: effect on biomechanical and histological properties. Cell Tissue Bank, 2015, 16(3): 467-475.
34.	Irani M, Lovric V, Walsh WR. Effects of supercritical fluid CO₂ and 25 kGy gamma irradiation on the initial mechanical properties and histological appearance of tendon allograft. Cell Tissue Bank, 2018, 19(4): 603-612.
35.	Baldini T, Caperton K, Hawkins M, et al. Effect of a novel sterilization method on biomechanical properties of soft tissue allografts. Knee Surg Sports Traumatol Arthrosc, 2016, 24(12): 3971-3975.
36.	Suarez LS, Richmond JC. Overview of procurement, processing, and sterilization of soft tissue allografts for sports medicine. Sports Med Arthrosc Rev, 2007, 15(3): 106-113.
37.	Oswald I, Rickert M, Brüggemann GP, et al. The influence of cryopreservation and quick-freezing on the mechanical properties of tendons. J Biomech, 2017, 64: 226-230.
38.	Chen L, Wu Y, Yu J, et al. Effect of repeated freezing-thawing on the Achilles tendon of rabbits. Knee Surg Sports Traumatol Arthrosc, 2011, 19(6): 1028-1034.
39.	Arnout N, Myncke J, Vanlauwe J, et al. The influence of freezing on the tensile strength of tendon grafts: a biomechanical study. Acta Orthop Belg, 2013, 79(4): 435-443.
40.	张洁, 华泽钊, 陈儿同. 冷冻外科中组织冻结的实验和理论研究. 中国医学物理学杂志, 2000, 17(4): 251-253.
41.	Vangsness CT Jr. Soft-tissue allograft processing controversies. J Knee Surg, 2006, 19(3): 215-219.
42.	Fanelli G, Casati A, Aldegheri G, et al. Cardiovascular effects of two different regional anaesthetic techniques for unilateral leg surgery. Acta Anaesthesiol Scand, 1998, 42(1): 80-84.
43.	Mahirogullari M, Ferguson CM, Whitlock PW, et al. Freeze-dried allografts for anterior cruciate ligament reconstruction. Clin Sports Med, 2007, 26(4): 625-637.
44.	Shino K, Kimura T, Hirose H, et al. Reconstruction of the anterior cruciate ligament by allogeneic tendon graft. An operation for chronic ligamentous insufficiency. J Bone Joint Surg (Br), 1986, 68(5): 739-746.
45.	Issın A, Öner A, Sofu H, et al. Comparison of freeze-dried tibialis anterior allograft and four-strand hamstring autograft in anterior cruciate ligament reconstruction. Acta Orthop Traumatol Turc, 2019, 53(1): 45-49.
46.	Sterling JC, Meyers MC, Calvo RD. Allograft failure in cruciate ligament reconstruction. Follow-up evaluation of eighteen patients. Am J Sports Med, 1995, 23(2): 173-178.
47.	Gut G, Marowska J, Jastrzebska A, et al. Structural mechanical properties of radiation-sterilized human Bone-Tendon-Bone grafts preserved by different methods. Cell Tissue Bank, 2016, 17(2): 277-287.

1. Gans I, Retzky JS, Jones LC, et al. Epidemiology of recurrent anterior cruciate ligament injuries in National Collegiate Athletic Association Sports: The Injury Surveillance Program, 2004-2014. Orthop J Sports Med, 2018, 6(6): 1-7.
2. Mehran N, Moutzouros VB, Bedi A. A review of current graft pptions for anterior cruciate ligament reconstruction. JBJS Rev, 2015, 3(11): 1-2.
3. 韩啸, 蒋青. 前交叉韧带重建三种移植物中长期临床效果对比研究进展. 中国运动医学杂志, 2018, 37(10): 886-890.
4. Wang HD, Zhu YB, Wang TR, et al. Irradiated allograft versus autograft for anterior cruciate ligament reconstruction: A meta-analysis and systematic review of prospective studies. Int J Surg, 2018, 49: 45-55.
5. Roberson TA, Abildgaard JT, Wyland DJ, et al. " Proprietary processed” allografts: clinical outcomes and biomechanical properties in anterior cruciate ligament reconstruction. Am J Sports Med, 2017, 45(13): 3158-3167.
6. Díaz-de-Rada P, Barriga A, Barroso JL, et al. Positive culture in allograft ACL-reconstruction: what to do? Knee Surg Sports Traumatol Arthrosc, 2003, 11(4): 219-222.
7. Tomford WW. Transmission of disease through transplantation of musculoskeletal allografts. J Bone Joint Surg (Am), 1995, 77(11): 1742-1754.
8. Asselmeier MA, Caspari RB, Bottenfield S. A review of allograft processing and sterilization techniques and their role in transmission of the human immunodeficiency virus. Am J Sports Med, 1993, 21(2): 170-175.
9. Cohen SB, Sekiya JK. Allograft safety in anterior cruciate ligament reconstruction. Clin Sports Med, 2007, 26(4): 597-605.
10. Whitlock PW, Seyler TM, Parks GD, et al. A novel process for optimizing musculoskeletal allograft tissue to improve safety, ultrastructural properties, and cell infiltration. J Bone Joint Surg (Am), 2012, 94(16): 1458-1467.
11. 赵彦涛, 刘思扬, 尹惠琼, 等. γ 射线终末辐照对同种异体肌腱病毒灭活效果及生物力学性能影响的研究. 中国骨与关节杂志, 2018, 7(5): 389-393.
12. Lansdown DA, Riff AJ, Meadows M, et al. What factors influence the biomechanical properties of allograft tissue for ACL reconstruction? A systematic review. Clin Orthop Relat Res, 2017, 475(10): 2412-2426.
13. Yanke AB, Bell R, Lee A, et al. The biomechanical effects of 1. 0 to 1. 2 Mrad of γ irradiation on human bone-patellar tendon-bone allografts. Am J Sports Med, 2013, 41(4): 835-840.
14. Fideler BM, Vangsness CT Jr, Lu B, et al. Gamma irradiation: effects on biomechanical properties of human bone-patellar tendon-bone allografts. Am J Sports Med, 1995, 23(5): 643-646.
15. Greaves LL, Hecker AT, Brown CH Jr. The effect of donor age and low-dose gamma irradiation on the initial biomechanical properties of human tibialis tendon allografts. Am J Sports Med, 2008, 36(7): 1358-1366.
16. Hamer AJ, Stockley I, Elson RA. Changes in allograft bone irradiated at different temperatures. J Bone Joint Surg (Br), 1999, 81(2): 342-344.
17. Balsly CR, Cotter AT, Williams LA, et al. Effect of low dose and moderate dose gamma irradiation on the mechanical properties of bone and soft tissue allografts. Cell Tissue Bank, 2008, 9(4): 289-298.
18. Zhou M, Zhang N, Liu X, et al. Tendon allograft sterilized by peracetic acid/ethanol combined with gamma irradiation. J Orthop Sci, 2014, 19(4): 627-636.
19. Seto AU, Gatt CJ, Dunn MG. Sterilization of tendon allografts: a method to improve strength and stability after exposure to 50 kGy gamma radiation. Cell Tissue Bank, 2013, 14(3): 349-357.
20. Ng KW, Wanivenhaus F, Chen T, et al. Differential cross-linking and radio-protective effects of genipin on mature bovine and human patella tendons. Cell Tissue Bank, 2013, 14(1): 21-32.
21. Schmidt T, Hoburg A, Broziat C, et al. Sterilization with electron beam irradiation influences the biomechanical properties and the early remodeling of tendon allografts for reconstruction of the anterior cruciate ligament (ACL). Cell Tissue Bank, 2012, 13(3): 387-400.
22. Hoburg AT, Keshlaf S, Schmidt T, et al. Effect of electron beam irradiation on biomechanical properties of patellar tendon allografts in anterior cruciate ligament reconstruction. Am J Sports Med, 2010, 38(6): 1134-1140.
23. Hashemi S, Gholamhosseinpour A, Niakousari M. Application of microwave and ohmic heating for pasteurization of cantaloupe juice: Microbial inactivation and chemical properties. J Sci Food Agric, 2019, 99(9): 20-25.
24. Proffen BL, Perrone GS, Fleming BC, et al. Effect of low-temperature ethylene oxide and electron beam sterilization on the in vitro and in vivo function of reconstituted extracellular matrix-derived scaffolds. J Biomater Appl, 2015, 30(4): 435-449.
25. Almeida OM, Jorgetti W, Oksman D, et al. Comparative study and histomorphometric analysis of bone allografts lyophilized and sterilized by autoclaving, gamma irradiation and ethylene oxide in rats. Acta Cir Bras, 2013, 28(1): 66-71.
26. Drez DJ, DeLee J, Holden JP, et al. Anterior cruciate ligament reconstruction using bone-patellar tendon-bone allografts. A biological and biomechanical evaluation in goats. Am J Sports Med, 1991, 19(3): 256-263.
27. Scheffler S, Trautmann S, Smith M, et al. No influence of collagenous proteins of Achilles tendon, skin and cartilage on the virus-inactivating efficacy of peracetic acid-ethanol. Biologicals, 2007, 35(4): 355-359.
28. Maletis GB, Chen J, Inacio M, et al. Increased risk of revision after anterior cruciate ligament reconstruction with soft tissue allografts compared with autografts: graft processing and time make a difference. Am J Sports Med, 2017, 45(8): 1837-1844.
29. Tejwani SG, Chen J, Funahashi TT, et al. Revision risk after allograft anterior cruciate ligament reconstruction: association with graft processing techniques, patient characteristics, and graft type. Am J Sports Med, 2015, 43(11): 2696-2705.
30. Schimizzi A, Wedemeyer M, Odell T, et al. Effects of a novel sterilization process on soft tissue mechanical properties for anterior cruciate ligament allografts. Am J Sports Med, 2007, 35(4): 612-616.
31. Phipps A, Vaynshteyn E, Kowalski JB, et al. Chemical sterilization of allograft dermal tissues. Cell Tissue Bank, 2017, 18(4): 573-584.
32. Park SS, Dwyer T, Congiusta F, et al. Analysis of irradiation on the clinical effectiveness of allogenic tissue when used for primary anterior cruciate ligament reconstruction. Am J Sports Med, 2015, 43(1): 226-235.
33. Bui D, Lovric V, Oliver R, et al. Meniscal allograft sterilisation: effect on biomechanical and histological properties. Cell Tissue Bank, 2015, 16(3): 467-475.
34. Irani M, Lovric V, Walsh WR. Effects of supercritical fluid CO₂ and 25 kGy gamma irradiation on the initial mechanical properties and histological appearance of tendon allograft. Cell Tissue Bank, 2018, 19(4): 603-612.
35. Baldini T, Caperton K, Hawkins M, et al. Effect of a novel sterilization method on biomechanical properties of soft tissue allografts. Knee Surg Sports Traumatol Arthrosc, 2016, 24(12): 3971-3975.
36. Suarez LS, Richmond JC. Overview of procurement, processing, and sterilization of soft tissue allografts for sports medicine. Sports Med Arthrosc Rev, 2007, 15(3): 106-113.
37. Oswald I, Rickert M, Brüggemann GP, et al. The influence of cryopreservation and quick-freezing on the mechanical properties of tendons. J Biomech, 2017, 64: 226-230.
38. Chen L, Wu Y, Yu J, et al. Effect of repeated freezing-thawing on the Achilles tendon of rabbits. Knee Surg Sports Traumatol Arthrosc, 2011, 19(6): 1028-1034.
39. Arnout N, Myncke J, Vanlauwe J, et al. The influence of freezing on the tensile strength of tendon grafts: a biomechanical study. Acta Orthop Belg, 2013, 79(4): 435-443.
40. 张洁, 华泽钊, 陈儿同. 冷冻外科中组织冻结的实验和理论研究. 中国医学物理学杂志, 2000, 17(4): 251-253.
41. Vangsness CT Jr. Soft-tissue allograft processing controversies. J Knee Surg, 2006, 19(3): 215-219.
42. Fanelli G, Casati A, Aldegheri G, et al. Cardiovascular effects of two different regional anaesthetic techniques for unilateral leg surgery. Acta Anaesthesiol Scand, 1998, 42(1): 80-84.
43. Mahirogullari M, Ferguson CM, Whitlock PW, et al. Freeze-dried allografts for anterior cruciate ligament reconstruction. Clin Sports Med, 2007, 26(4): 625-637.
44. Shino K, Kimura T, Hirose H, et al. Reconstruction of the anterior cruciate ligament by allogeneic tendon graft. An operation for chronic ligamentous insufficiency. J Bone Joint Surg (Br), 1986, 68(5): 739-746.
45. Issın A, Öner A, Sofu H, et al. Comparison of freeze-dried tibialis anterior allograft and four-strand hamstring autograft in anterior cruciate ligament reconstruction. Acta Orthop Traumatol Turc, 2019, 53(1): 45-49.
46. Sterling JC, Meyers MC, Calvo RD. Allograft failure in cruciate ligament reconstruction. Follow-up evaluation of eighteen patients. Am J Sports Med, 1995, 23(2): 173-178.
47. Gut G, Marowska J, Jastrzebska A, et al. Structural mechanical properties of radiation-sterilized human Bone-Tendon-Bone grafts preserved by different methods. Cell Tissue Bank, 2016, 17(2): 277-287.

Chinese Journal of Reparative and Reconstructive Surgery

Progress of sterilization and preservation methods for allografts in anterior cruciate ligament reconstruction

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