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Novel sterilization process shows minimal effect on allograft mechanical properties

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SAN FRANCISCO — A novel electron beam sterilization process appears to only minimally affect the mechanical properties of tendon allografts, according to an in vitro study by researchers from Germany.

Sven U. Scheffler, MD, and colleagues evaluated the suitability of the sterilization process by quantifying its effects on the mechanical properties of 32 human bone-patellar tendon-bone allografts. They presented their results in a poster at the 54th Annual Meeting of the Orthopaedic Research Society.

The study involved grafts measuring 10 mm in width. Investigators randomly assigned each graft into one of four sterilization groups; either no sterilization or irradiation applied at 15 kGy, 25 kGy or 34 kGy, according to the study.

Each graft was placed into an individual gas-impermeable sterilization bag filled with CO2 and placed into a polystyrene box filled with dry ice.

"Viscoelastic properties did not vary among treatment groups, with no significant differences found for strain and creep behavior derived from the markers during the cyclic loading phase," the authors said in the study.

"There were no significant differences among the respective groups for the structural properties, with the exception of the 34 kGy group, that had significantly lower failure loads than the non-irradiated control," they said.

The 34 kGy-irradiated group failed at approximately 1,500 N, compared to approximately 2,000 N for the non-irradiated group, according to the study.

"Although the highest dose of 34 kGy [produced] a significantly lower failure load, the stiffness was not affected and no significant viscoelastic component arising from the cyclic loading could be detected in any of the treatment groups," they said.

For more information:

• Scheffler SU, Keshlaf S, Pruss A, et al. Biomechanical properties of soft tissue allografts are not impaired by a novel sterilization technique based on electron beam radiation. Presented at the 54th Annual Meeting of the Orthopaedic Research Society. March 2-5, 2008. San Francisco.