Gamma irradiation: effects on biomechanical properties of human bone-patellar tendon-bone allografts.

Sixty 10-mm bone-patellar tendon-bone allografts from young human donors were placed into four test groups, a control fresh-frozen group and three fresh-frozen irradiated groups. The irradiated groups were exposed to 2.0, 3.0, or 4.0 Mrad of gamma irradiation. The specimens were tested to tensile failure. The initial biomechanical strength of fresh-frozen allografts was reduced up to 15% when compared with fresh-frozen controls after 2.0 Mrad of irradiation. Maximum force, strain energy, modulus, and maximum stress demonstrated a statistically significant reduction after 2.0 Mrad of irradiation (P < 0.01). Stiffness, elongation, and strain were reduced but not with statistical significance. A 10% to 24% and 19% to 46% reduction in all biomechanical properties were found after 3.0 (P < 0.005) and 4.0 (P < 0.0005) Mrad of irradiation, respectively. After irradiation with a 4.0 Mrad dose, the ultimate load was below that of reported values for the human anterior cruciate ligament. It is clinically important to observe and document changes in human ligaments that result from currently used doses of gamma irradiation. The results from this study provide important information regarding the initial biomechanical properties of fresh-frozen human bone-patellar tendon-bone allografts after bacterial sterilization with gamma irradiation. The current accepted dose for sterilization is between 1.5 and 2.5 Mrad. There appeared to be a dose-dependent effect of irradiation on all the biomechanical parameters studied. Four of seven parameters were found to be reduced after 2.0 Mrad of irradiation. Reductions were found in all parameters after 3.0 and 4.0 Mrad of irradiation.