Advertisement

Cell and Tissue Banking

, Volume 16, Issue 2, pp 219–226 | Cite as

High-dose electron beam sterilization of soft-tissue grafts maintains significantly improved biomechanical properties compared to standard gamma treatment

  • A. HoburgEmail author
  • S. Keshlaf
  • T. Schmidt
  • M. Smith
  • U. Gohs
  • C. Perka
  • A. Pruss
  • S. Scheffler
Original Paper

Abstract

Allografts have gained increasing popularity in anterior cruciate ligament (ACL) reconstruction. However, one of the major concerns regarding allografts is the possibility of disease transmission. Electron beam (Ebeam) and Gamma radiation have been proven to be successful in sterilization of medical products. In soft tissue sterilization high dosages of gamma irradiation have been shown to be detrimental to biomechanical properties of grafts. Therefore, it was the objective of this study to compare the biomechanical properties of human bone-patellar tendon-bone (BPTB) grafts after ebeam with standard gamma irradiation at medium (25 kGy) and high doses (34 kGy). We hypothesized that the biomechanical properties of Ebeam irradiated grafts would be superior to gamma irradiated grafts. Paired 10 mm-wide human BPTB grafts were harvested from 20 donors split into four groups following irradiation with either gamma or Ebeam (each n = 10): (A) Ebeam 25 kGy, (B) Gamma 25 kGy, (C) Ebeam 34 kGy (D) Gamma 34 kGy and ten non-irradiated BPTB grafts were used as controls. All grafts underwent biomechanical testing which included preconditioning (ten cycles, 0–20 N); cyclic loading (200 cycles, 20–200 N) and a load-to-failure (LTF) test. Stiffness of non-irradiated controls (199.6 ± 59.1 N/mm) and Ebeam sterilized grafts did not significantly differ (152.0 ± 37.0 N/mm; 192.8 ± 58.0 N/mm), while Gamma-irradiated grafts had significantly lower stiffness than controls at both irradiation dosages (25 kGy: 126.1 ± 45.4 N/mm; 34 kGy: 170.6 ± 58.2 N/mm) (p < 0.05). Failure loads at 25 kGy were significantly lower in the gamma group (1,009 ± 400 N), while the failure load was significantly lower in both study groups at high dose irradiation with 34 kGy (Ebeam: 1,139 ± 445 N, Gamma: 1,073 ± 617 N) compared to controls (1,741 ± 304 N) (p < 0.05). Creep was significantly larger in the gamma irradiated groups (25 kGy: 0.96 ± 1.34 mm; 34 kGy: 1.06 ± 0.58 mm) than in the Ebeam (25 kGy: 0.50 ± 0.34 mm; 34 kGy: 0.26 ± 0.24 mm) and control (0.20 ± 0.18 mm) group that did not differ significantly. Strain difference was not different between either control or study groups (controls: 1.0 ± 0.03; Ebeam 34 kGy 1.04 ± 0.018; Gamma 34 kGy 1.0 ± 0.028; 25 kGy: 1.4 ± 2,0; 34 kGy: 1.1 ± 1.1). The most important result of this study was that ebeam irradiation showed significantly less impairment of the biomechanical properties than gamma irradiation. Considering the results of this study and the improved control of irradiation application with electronic beam, this technique might be a promising alternative in soft-tissue sterilization.

Keywords

Allograft ACL reconstruction Sterilization Ebeam Gamma irradiation 

References

  1. Anderson MJ, Keyak JH, Skinner HB (1992) Compressive mechanical properties of human cancellous bone after gamma irradiation. J Bone Joint Surg Am 74(5):747–752PubMedGoogle Scholar
  2. Bach BR Jr et al (2005) Primary anterior cruciate ligament reconstruction using fresh-frozen, nonirradiated patellar tendon allograft: minimum 2-year follow-up. Am J Sports Med 33(2):284–292CrossRefPubMedGoogle Scholar
  3. Bailey AJ, Rhodes DN, Cater CW (1964) Irradiation-induced crosslinking of collagen. Radiat Res 22:606–621CrossRefPubMedGoogle Scholar
  4. Currey JD et al (1997) Effects of ionizing radiation on the mechanical properties of human bone. J Orthop Res 15(1):111–117CrossRefPubMedGoogle Scholar
  5. Dziedzic-Goclawska, A.(2000), Application of ionising radiation to sterilise connective tissue allografts. Radiation and Tissue Banking, ed. P.G.O. (ed.) Phillips G.O. (ed.)Google Scholar
  6. Dziedzic-Goclawska A et al (2005) Irradiation as a safety procedure in tissue banking. Cell Tissue Bank 6(3):201–219CrossRefPubMedGoogle Scholar
  7. Eastlund T (2006) Bacterial infection transmitted by human tissue allograft transplantation. Cell Tissue Bank 7(3):147–166CrossRefPubMedGoogle Scholar
  8. Fideler BM et al (1995) Gamma irradiation: effects on biomechanical properties of human bone-patellar tendon-bone allografts. Am J Sports Med 23(5):643–646CrossRefPubMedGoogle Scholar
  9. Gibbons MJ et al (1991) Effects of gamma irradiation on the initial mechanical and material properties of goat bone-patellar tendon-bone allografts. J Orthop Res 9(2):209–218CrossRefPubMedGoogle Scholar
  10. IAEA (1990), IAEA guidelines for industrial radiation sterilization of disposable medical products (Cobalt-60 Gamma Irradiation)Google Scholar
  11. Jastrzebska, A., et al. (2013), Effect of gamma radiation and accelerated electron beam on stable paramagnetic centers induction in bone mineral: influence of dose, irradiation temperature and bone defatting. Cell Tissue BankGoogle Scholar
  12. Kaminski A et al (2012a) Effect of accelerated electron beam on mechanical properties of human cortical bone: influence of different processing methods. Cell Tissue Bank 13(3):375–386CrossRefPubMedCentralPubMedGoogle Scholar
  13. Kaminski A et al (2012b) Effect of gamma irradiation on mechanical properties of human cortical bone: influence of different processing methods. Cell Tissue Bank 13(3):363–374CrossRefPubMedGoogle Scholar
  14. Klose, B. (2006). A process for the preparation of a package comprising a sterilized bulk of a drug substance, and a package comprising a sterilized bulk of a penicillinGoogle Scholar
  15. Mae T et al (2003) Effect of gamma irradiation on remodeling process of tendon allograft. Clin Orthop Relat Res 414:305–314CrossRefPubMedGoogle Scholar
  16. McAllister DR et al (2007) Allograft update: the current status of tissue regulation, procurement, processing, and sterilization. Am J Sports Med 35(12):2148–2158CrossRefPubMedGoogle Scholar
  17. Nguyen H, Morgan DA, Forwood MR (2007a) Sterilization of allograft bone: effects of gamma irradiation on allograft biology and biomechanics. Cell Tissue Bank 8(2):93–105CrossRefPubMedGoogle Scholar
  18. Nguyen H, Morgan DA, Forwood MR (2007b) Sterilization of allograft bone: is 25 kGy the gold standard for gamma irradiation? Cell Tissue Bank 8(2):81–91CrossRefPubMedGoogle Scholar
  19. Pruss A et al (2002) Effect of gamma irradiation on human cortical bone transplants contaminated with enveloped and non-enveloped viruses. Biologicals 30(2):125–133CrossRefPubMedGoogle Scholar
  20. Rasmussen TJ et al (1994) The effects of 4 Mrad of gamma irradiation on the initial mechanical properties of bone-patellar tendon-bone grafts. Arthroscopy 10(2):188–197CrossRefPubMedGoogle Scholar
  21. Russell, A. (1992), Principles, practice of disinfection, preservation and sterilization. Principles, Practice of Disinfection, Preservation and Sterilization. Oxford, UK: Blackwell Scientific PublicationsGoogle Scholar
  22. Salehpour A et al (1995) Dose-dependent response of gamma irradiation on mechanical properties and related biochemical composition of goat bone-patellar tendon-bone allografts. J Orthop Res 13(6):898–906CrossRefPubMedGoogle Scholar
  23. Scheffler SU et al (2005) Biomechanical comparison of human bone-patellar tendon-bone grafts after sterilization with peracetic acid ethanol. Cell Tissue Bank 6(2):109–115CrossRefPubMedGoogle Scholar
  24. Seto A, Gatt CJ Jr, Dunn MG (2008) Radioprotection of tendon tissue via crosslinking and free radical scavenging. Clin Orthop Relat Res 466(8):1788–1795CrossRefPubMedCentralPubMedGoogle Scholar
  25. Yusof N (2000) Irradiation for sterilising tissue grafts for viral inactivation. Malays J Nucl Sci 18(1):23–35Google Scholar
  26. Yusof, N.(2006), Radiation in Tissue Banking - Basic Science and Clinical Applications of Irradiated Tissue Allografts, A. Nather (ed), Singapore: World Scientific Publishing Co. Ptc. Ltd. 561Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2014

Authors and Affiliations

  • A. Hoburg
    • 1
    Email author
  • S. Keshlaf
    • 2
  • T. Schmidt
    • 1
  • M. Smith
    • 3
  • U. Gohs
    • 4
  • C. Perka
    • 1
  • A. Pruss
    • 2
  • S. Scheffler
    • 5
  1. 1.Department for Orthopaedic Surgery and Traumatology, Center for Muskuloskeletal Surgery, Sports Medicine and Arthroscopy ServiceCharité University Medicine BerlinBerlinGermany
  2. 2.Institute for Transfusion Medicine (Tissue Bank)Charité University Medicine BerlinBerlinGermany
  3. 3.German Institute for Cell and Tissue Replacement (DIZG)BerlinGermany
  4. 4.Leibniz-Institute of Polymer Research DresdenDresdenGermany
  5. 5.Chirurgisch Orthopaedischer PraxisVerbund (COPV)BerlinGermany

Personalised recommendations