Fractionation of high-dose electron beam irradiation of BPTB grafts provides significantly improved viscoelastic and structural properties compared to standard gamma irradiation

Purpose

Irradiation >30 kGy is required to achieve sterility against bacterial and viral pathogens in ACL allograft sterilization. However, doses >20 kGy substantially reduce the structural properties of soft-tissue grafts. Fractionation of irradiation doses is a standard procedure in oncology to reduce tissue damage but has not been applied in tissue graft sterilization.

Methods

Forty-four human 10-mm wide bone-patellar-tendon-bone grafts were randomized into four groups of sterilization with (1) 34 kGy of ebeam (2) 34 kGy gamma (3) 34 kGy fractionated ebeam, and (4) non sterilized controls. Graft´s biomechanical properties were evaluated at time zero. Biomechanical properties were analyzed during cyclic and load-to-failure testing.

Results

Fractionation of ebeam irradiation resulted in significantly higher failure loads (1,327 ± 305) than with one-time ebeam irradiation (1,024 ± 204; P = 0.008). Compared to gamma irradiation, significantly lower strain (2.9 ± 1.5 vs. 4.6 ± 2.0; P = 0.008) and smaller cyclic elongation response (0.3 ± 0.2 vs. 0.6 ± 0.4; P = 0.05), as well as higher failure loads (1,327 ± 305 vs. 827 ± 209; P = 0.001), were found. Compared to non-irradiated BPTB grafts, no significant differences were found for any of the biomechanical parameters. Non-irradiated controls had significantly lower cyclic elongation response and higher failure loads than ebeam and gamma irradiation.

Conclusions

In this study, it was found that fractionation of high-dose electron beam irradiation facilitated a significant improvement of viscoelastic and structural properties of BPTB grafts compared to ebeam and gamma irradiation alone, while maintaining levels of non-irradiated controls. Therefore, this technique might pose an important alternative to common methods for sterilization of soft-tissue allografts.