Inactivation Effect of Standard and Fractionated Electron Beam Irradiation on Enveloped and Non-Enveloped Viruses in a Tendon Transplant Model.

BACKGROUND: For increasing allograft tendon safety in reconstructive surgery, an effective sterilization method achieving sterility assurance including viruses without impairing the grafts properties is needed. Fractionated Electron Beam (Ebeam) has shown promising in vitro results. The proof of sufficient virus inactivation is a central part of the process validation. METHODS: The Ebeam irradiation of the investigated viruses was performed in an optimized manner (oxygen content < 0.1%, -78 °C). Using principles of a tendon model the virus inactivation kinetics for HIV-2, HAV, pseudorabies virus (PRV) and porcine parvovirus (PPV) were calculated as TCID(50)/ml and D(10) value (kGy) for the fractionated (10 × 3.4 kGy) and the standard (1 × 34 kGy) Ebeam irradiation. RESULTS: All viruses showed comparable D(10) values for both Ebeam treatments. For sufficient virus titer reduction of 4 log(10) TCID(50)/ml, a dose of 34 kGy of the fractionated Ebeam irradiation was necessary in case of HIV-2, which was the most resistant virus investigated in this study. CONCLUSION: The fractionated and the standard Ebeam irradiation procedure revealed comparable and sufficient virus inactivation capacities. In combination with the known good biomechanical properties of fractionated Ebeam irradiated tendons, this method could be a safe and effective option for the terminal sterilization of soft tissue allografts.

Effect of electron beam irradiation on biomechanical properties of patellar tendon allografts in anterior cruciate ligament reconstruction.

BACKGROUND: Sterilization of anterior cruciate ligament (ACL) allografts is an important prerequisite to prevent disease transmission. However, mechanical tissue properties are compromised by most current sterilization procedures, so that uncompromised sterilization of allografts is difficult to achieve. Hypothesis/ PURPOSE: The aim of this study was to evaluate the effect of the novel electron beam sterilization procedure on the biomechanical properties of human patellar tendon allografts at various irradiation dosages. Electron beam sterilization may be an appropriate alternative to gamma sterilization. STUDY DESIGN: Controlled laboratory study. METHODS: Thirty-two human 10-mm wide bone-patellar tendon-bone grafts were randomized into 4 groups of sterilization with 15, 25, or 34 kGy of electron beam irradiation, respectively. The grafts' biomechanical properties were evaluated at time zero. Unsterilized grafts functioned as controls. Biomechanical properties were analyzed during cyclic and load-to-failure testing. RESULTS: Strain and cyclic elongation response showed no significant differences between the groups. Electron beam irradiation had no significant effect on stiffness and failure load with the exception of 34 kGy, which resulted in a significant decrease in failure load (1300.6 +/- 229.2 N) compared with unsterilized grafts (1630.5 +/- 331.1 N). CONCLUSION: This study showed that electron beam might be an appropriate alternative in sterilization of patellar tendon allografts with minimal effect on mechanical properties of tendon grafts in vitro. Future studies will have to evaluate the effect of the process on the biological properties of allografts in vitro and in vivo. CLINICAL RELEVANCE: Terminal sterilization of patellar tendon allografts with electron beam irradiation can ensure higher safety of transplanted grafts and hence improve patient safety and acceptance.

Case reports: fractures of threaded cups: rare complications of a well-established implant.

The use of cementless threaded cups in THA is a well-established treatment. Fractures of the cups are rare complications recorded in individual cases with material defects being discussed as the primary cause. We analyzed three cases of fractured cups. Although all three cups were well fixed to existing bone, we observed deficient osseous backing dorsocranially and abrasion particles. There were no signs of femoroacetabular impingement or infection. The cups showed corrosion debris. Scanning electron microscopic investigations showed characteristics of fretting and fretting-related corrosion. We concluded the fractures occurred because of fretting combined with inadequate bony support leading to fatigue of the material and subsequent fracture.