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Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior Cruciate Ligament Allografts

Aimee Schimizzi, MD^*, Michelle Wedemeyer, Tim Odell, Walter Thomas, MD^*, Andrew T. Mahar, MS^*,, and Robert Pedowitz, MD, PhD^*

From the ^* Department of Orthopaedic Surgery, University of California at San Diego, San Diego, California, and Orthopedic Biomechanics Research Center, Department of Orthopedics, Children’s Hospital–San Diego, San Diego, California

Address correspondence to Andrew T. Mahar, MS, MC5054, 3020 Children’s Way, San Diego, CA 92123 (e-mail: amahar{at}chsd.org).

Background: Allograft anterior cruciate ligament reconstruction provides benefits such as earlier return to activities and less pain, but concerns remain regarding potential infection and biomechanical stability.

Hypothesis: There is no difference in biomechanical properties of soft tissue allografts treated with the Biocleanse tissue sterilization process compared with irradiated and fresh-frozen allografts.

Study Design: Controlled laboratory study.

Methods: Thirty-six tibialis anterior allografts were equally divided between Biocleanse, irradiated, and fresh-frozen groups. Grafts were measured for cross-sectional area and looped over a smooth rod with the free sutured ends of the graft fixed in custom clamps. Specimens were tensioned to 10 N for 2 minutes and then loaded between 50 and 300 N for 1000 cycles followed by a failure test. Data for creep (mm); stiffness (N/mm) at cycles 1, 10, 100, and 1000; failure load (N); and failure stress (MPa) were compared with a one-way analysis of variance (P < .05).

Results: There were no statistically significant differences in creep between groups. Sterilized groups (irradiated = 144.7 ± 17.7 N/mm and Biocleanse = 146.5 ± 28.2N/mm) were significantly stiffer during the first cycle than the fresh-frozen group (117.8 ± 15.7 N/mm, P < .005) without statistically significant differences for subsequent cycles. There were no differences between groups for either failure load (fresh-frozen = 1665 ± 291.3 N, irradiated = 1671.9 ± 290.2 N, Biocleanse = 1651.6 ± 377.4 N) or failure stress.

Conclusion: Data for "time-zero" physiologic stiffness and failure loads indicate that the Biocleanse process does not adversely affect the biomechanical properties of the allograft material.

Clinical Relevance: This novel sterilization technique may provide surgeons with potential allograft material with similar biomechanical properties to native tissue.

Key Words: anterior cruciate ligament reconstruction • allograft • sterilization • biomechanical stability