The effect of sterilization on mechanical properties of soft tissue allografts.

One major concern regarding soft tissue allograft use in surgical procedures is the risk of disease transmission. Current techniques of tissue sterilization, such as irradiation have been shown to adversely affect the mechanical properties of soft tissues. Grafts processed using Biocleanse processing (a proprietary technique developed by Regeneration Technologies to sterilize human tissues) will have better biomechanical characteristics than tissues that have been irradiated. Fifteen pairs of cadaveric Achilles tendon allografts were obtained and separated into three groups of 10 each. Three treatment groups were: Biocleanse, Irradiated, and Control (untreated). Each specimen was tested to determine the biomechanical properties of the tissue. Specimens were cyclically preloaded and then loaded to failure in tension. During testing, load, displacement, and optical strain data were captured. Following testing, the cross sectional area of the tendons was determined. Tendons in the control group were found to have a higher extrinsic stiffness (slope of the load-deformation curve, p = .005), have a higher ultimate stress (force/cross sectional area, p = .006) and higher ultimate failure load (p = .003) than irradiated grafts. Biocleanse grafts were also found to be stiffer than irradiated grafts (p = .014) yet were not found to be statistically different from either irradiated or non-irradiated grafts in terms of load to failure. Biocleanse processing seems to be a viable alternative to irradiation for Achilles tendon allografts sterilization in terms of their biomechanical properties.

Nonirradiated versus irradiated Achilles allograft: in vivo failure comparison.

BACKGROUND: Many studies suggest that gamma irradiation decreases allograft strength in a dose-dependent manner. No study has demonstrated that this decrease in strength translates into higher clinical failures. HYPOTHESIS: Irradiation of allograft tissue will lead to higher early clinical failure in anterior cruciate ligament (ACL) reconstruction. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Medical records were reviewed for 90 consecutive patients who had received Achilles allograft reconstruction for unilateral primary ACL injuries at one institution between July 2001 and June 2002. One half of patients received nonirradiated Achilles allograft and the other half received irradiated Achilles allograft at a dose range of 2.0 to 2.5 Mrad. The ACL allograft reconstructions were performed using the same surgical technique. The rehabilitation program was identical for both groups. All clinical failures were recorded. RESULTS: At least 6 months' follow-up was available on 42 subjects in the nonirradiated group and 33 subjects in the irradiated group. A significant difference was noted in early failure rates between the groups (P <.01). The nonirradiated group had 1 in 42 (2.4%) catastrophic failure. In the irradiated group, 11 of 33 (33%) Achilles tendon grafts failed. CONCLUSIONS: Less than satisfactory results led the senior authors to discontinue the use of irradiated allografts in ACL surgery. Continued research into alternatives to gamma irradiation is needed.