Log in

Effect of a novel sterilization method on biomechanical properties of soft tissue allografts

  • Experimental Study
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

Evaluate allograft tissue commonly used in soft tissue reconstruction to determine whether stiffness and strength were significantly altered after grafts were treated with different sterilization methods. Unprocessed, irradiated, and grafts treated with supercritical CO2 were compared.

Methods

Thirty-eight anterior or posterior tibialis tendons were obtained from a tissue bank (Allograft Innovations, Gainesville, FL). Group I was unprocessed, group II was sterilized with gamma irradiation (20–28 kGy), and group III was sterilized with supercritical CO2. The grafts were pretensioned to 89 N for 300 s. Specimens were then loaded from 50 to 300 N at 0.5 Hz for 250 cycles before being loaded to failure at 50 mm/min. Dependent variables were compared between sterilization groups with one-way ANOVA (P < 0.05) and equivalence trial.

Results

There was no significant difference in load to failure or failure stress among groups I, II, and III. Group III resulted in 27–36 % lower stiffness than group I and II. This difference was significant at 1, 10, 50, 100, and 250 cycles. There was no significant difference in stiffness between group I and group II.

Conclusion

The two sterilization methods tested in this study do not affect allograft strength. The supercritical CO2 sterilization method resulted in significantly lower stiffness than unprocessed and irradiated allografts. However, the stiffness and strength of all groups tested were greater than that of published values of the native intact anterior cruciate ligament (ACL). This study provides previously unpublished mechanical test data on a new sterilization technique that will assist surgeons to decide which allograft to use in ACL reconstruction surgery.

Level of evidence

III.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Barrera Oro F, Sikka RS, Wolters B, Graver R, Boyd JL, Nelson B, Swiontkowski MF (2011) Autograft versus allograft: an economic cost comparison of anterior cruciate ligament reconstruction. Arthroscopy 27(9):1219–1225

    Article  PubMed  Google Scholar 

  2. Bhatia S, Bell R, Frank RM, Rodeo SA, Bach BR Jr, Cole BJ, Chubinskaya S, Wang VM, Verma NN (2012) Bony incorporation of soft tissue anterior cruciate ligament grafts in an animal model: autograft versus allograft with low-dose gamma irradiation. Am J Sports Med 40(8):1789–1798

    Article  PubMed  Google Scholar 

  3. Chandrashekar N, Mansouri H, Slauterbeck J, Hashemi J (2006) Sex-based differences in the tensile properties of the human anterior cruciate ligament. J Biomech 39(16):2943–2950

    Article  PubMed  Google Scholar 

  4. Conrad BP, Rappe M, Horodyski M, Farmer KW, Indelicato PA (2013) The effect of sterilization on mechanical properties of soft tissue allografts. Cell Tissue Bank 14(3):359–366

    Article  CAS  PubMed  Google Scholar 

  5. Fideler BM, Vangsness CT Jr, Moore T, Li Z, Rasheed S (1994) Effects of gamma irradiation on the human immunodeficiency virus. A study in frozen human bone-patellar ligament-bone grafts obtained from infected cadavera. J Bone Joint Surg Am 76(7):1032–1035

    Article  CAS  PubMed  Google Scholar 

  6. Greis PE, Koch BS, Adams B (2012) Tibialis anterior or posterior allograft anterior cruciate ligament reconstruction versus hamstring autograft reconstruction: an economic analysis in a hospital-based outpatient setting. Arthroscopy 28(11):1695–1701

    Article  PubMed  Google Scholar 

  7. Guo L, Yang L, Duan XJ, He R, Chen GX, Wang FY, Zhang Y (2012) Anterior cruciate ligament reconstruction with bone-patellar tendon-bone graft: comparison of autograft, fresh-frozen allograft, and gamma-irradiated allograft. Arthroscopy 28(2):211–217

    Article  PubMed  Google Scholar 

  8. Harrington IJ (1976) A bioengineering analysis of force actions at the knee in normal and pathological gait. Biomed Eng 11(5):167–172

    CAS  PubMed  Google Scholar 

  9. Harris AH, Fernandes-Taylor S, Giori N (2012) “Not statistically different” does not necessarily mean “the same”: the important but underappreciated distinction between difference and equivalence studies. J Bone Joint Surg Am 94(5):e29

    Article  PubMed  Google Scholar 

  10. Hernigou P, Gras G, Marinello G, Dormont D (2000) Influence of irradiation on the risk of transmission of HIV in bone grafts obtained from appropriately screened donors and followed by radiation sterilization. Cell Tissue Bank 1(4):279–289

    Article  PubMed  Google Scholar 

  11. Hoburg AT, Keshlaf S, Schmidt T, Smith M, Gohs U, Perka C, Pruss A, Scheffler S (2010) Effect of electron beam irradiation on biomechanical properties of patellar tendon allografts in anterior cruciate ligament reconstruction. Am J Sports Med 38(6):1134–1140

    Article  PubMed  Google Scholar 

  12. Hu J, Qu J, Xu D, Zhou J, Lu H (2013) Allograft versus autograft for anterior cruciate ligament reconstruction: an up-to-date meta-analysis of prospective studies. Int Orthop 37(2):311–320

    Article  PubMed  Google Scholar 

  13. Huang Q, Ingham E, Rooney P, Kearney JN (2013) Production of a sterilised decellularised tendon allograft for clinical use. Cell Tissue Bank 14(4):645–654

    Article  CAS  PubMed  Google Scholar 

  14. Jackson DW, Grood ES, Goldstein JD, Rosen MA, Kurzweil PR, Cummings JF, Simon TM (1993) A comparison of patellar tendon autograft and allograft used for anterior cruciate ligament reconstruction in the goat model. Am J Sports Med 21(2):176–185

    Article  CAS  PubMed  Google Scholar 

  15. Krych AJ, Jackson JD, Hoskin TL, Dahm DL (2008) A meta-analysis of patellar tendon autograft versus patellar tendon allograft in anterior cruciate ligament reconstruction. Arthroscopy 24(3):292–298

    Article  PubMed  Google Scholar 

  16. Morrison JB (1970) The mechanics of the knee joint in relation to normal walking. J Biomech 3(1):51–61

    Article  CAS  PubMed  Google Scholar 

  17. Noyes FR, Grood ES (1976) The strength of the anterior cruciate ligament in humans and rhesus monkeys. J Bone Joint Surg Am 58(8):1074–1082

    Article  CAS  PubMed  Google Scholar 

  18. Schimizzi A, Wedemeyer M, Odell T, Thomas W, Mahar AT, Pedowitz R (2007) Effects of a novel sterilization process on soft tissue mechanical properties for anterior cruciate ligament allografts. Am J Sports Med 35(4):612–616

    Article  PubMed  Google Scholar 

  19. Schmidt T, Hoburg A, Broziat C, Smith MD, Gohs U, Pruss A, Scheffler S (2012) 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 13(3):387–400

    Article  CAS  PubMed  Google Scholar 

  20. Seto AU, Culp BM, Gatt CJ Jr, Dunn M (2013) Radioprotection provides functional mechanics but delays healing of irradiated tendon allografts after ACL reconstruction in sheep. Cell Tissue Bank 14(4):655–665

    Article  CAS  PubMed  Google Scholar 

  21. Shelburne KB, Torry MR, Pandy MG (2005) Muscle, ligament, and joint-contact forces at the knee during walking. Med Sci Sports Exerc 37(11):1948–1956

    Article  PubMed  Google Scholar 

  22. Sun K, Zhang J, Wang Y, **a C, Zhang C, Yu T, Tian S (2011) Arthroscopic anterior cruciate ligament reconstruction with at least 2.5 years’ follow-up comparing hamstring tendon autograft and irradiated allograft. Arthroscopy 27(9):1195–1202

    Article  PubMed  Google Scholar 

  23. White A, Burns D, Christensen TW (2006) Effective terminal sterilization using supercritical carbon dioxide. J Biotechnol 123(4):504–515

    Article  CAS  PubMed  Google Scholar 

  24. Woo SL, Hollis JM, Adams DJ, Lyon RM, Takai S (1991) Tensile properties of the human femur-anterior cruciate ligament-tibia complex. The effects of specimen age and orientation. Am J Sports Med 19(3):217–225

    Article  CAS  PubMed  Google Scholar 

  25. Yanke AB, Bell R, Lee A, Kang RW, Mather RC III, Shewman EF, Wang VM, Bach BR Jr (2013) The biomechanical effects of 1.0 to 1.2 Mrad of gamma irradiation on human bone-patellar tendon-bone allografts. Am J Sports Med 41(4):835–840

    Article  PubMed  Google Scholar 

  26. Zhou M, Zhang N, Liu X, Li Y, Zhang Y, Wang X, Li B (2014) Tendon allograft sterilized by peracetic acid/ethanol combined with gamma irradiation. J Orthop Sci. doi:10.1007/s00776-014-0556-9

    Google Scholar 

Download references

Acknowledgments

This study was funded by Stryker Orthopaedics (Mahwah, NJ, USA).

Conflict of interest

Monica Hawkins is an employee of Stryker Orthopaedics and owns stock in the company. This study was funded by Stryker Orthopaedics.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to T. Baldini.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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 24, 3971–3975 (2016). https://doi.org/10.1007/s00167-014-3221-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00167-014-3221-0

Keywords

Navigation