Terminal Sterilization of Anterior Cruciate Ligament (ACL) Allografts: A Systematic Review of Outcomes

Abstract

Introduction. Anterior cruciate ligament (ACL) injuries are common and reconstruction can be completed with either autograft or allograft tissue. However, there is concern about an increased failure rate with allograft tissue. The purpose of this study was to systematically review the available evidence to determine the effect of irradiation and level of dose on the failure rates of allograft in ACL reconstruction.

Methods. A literature search was performed using PubMed, Scopus, and Web of Science from January 2000 to September 2013. Inclusion criteria consisted of the following: (1) primary, unilateral, single-bundle allograft ACL procedure, (2) studies with data documenting graft type and terminal sterilization technique, (3) subjective assessments of outcome, and (4) objective assessments of outcome. Studies without reported subjective and objective outcomes and those pertaining to revision ACL reconstruction were excluded. Failures were defined and compared between irradiated and non-irradiated grafts, as well as between grafts irradiated with 1.2 - 1.8 Mrad and those with 2.0 - 2.5 Mrad.

Results. Of the 242 articles identified via initial search, 17 studies met the final inclusion criteria. A total of 1,090 patients were evaluated in this study, all having undergone unilateral primary ACL reconstruction with allograft tissue with 155 failures. The failure rate between non-irradiated (98/687, 14.7%) and irradiated (57/408, 14.0%) was not statistically significant (p = 0.86). Grafts in the high-dose irradiation group (27/135, 20.0%) had a statistically significant higher (p < 0.001) rate of failure than those in the low-dose irradiation group (30/273, 10.6%).

Conclusion. The irradiation of an allograft increases the risk of failure after an ACL reconstruction but the use of lower doses of radiation decreases that risk.