Background: It is important to know the biomechanical properties of an allograft. This is because when looking to do a transplant of a tendon, the tendon must have very similar biomechanical properties to the original tendon. To use tendon allografts, it is critical to properly sterilize the tendon before implantation. In past decades, several sterilization procedures have been used. This study aimed to systematically evaluate the existing literature to compare the values of failure load/ultimate strength and Young's modulus of elasticity of different sterilization methods on commonly used tendon allografts. Five major scientific literature databases (Web of Science, Science Direct, Scopus, PLOS ONE, Hindawi) and additional sources were used.
Results: Studies used had to show a particular sterilization method. Studies were identified to meet the following inclusion criteria: is a controlled laboratory study, gamma irradiation (dose reported), and other sterilization methods. Search for publications dated between 1991 and March 31st, 2020. The database search and additional sources resulted in 284 records. Two hundred thirty records eliminated during the screening for various reasons. The number of articles used in the final synthesis was 54.
Conclusions: Identified sterilization methods (gamma irradiation, ethylene oxid, supercritical carbon dioxide (SCCO2), BioCleanse, Electron Beam) are offered as a catalog of potential methods. As a result of the broadness of the present research, it provides an overview of sterilization methods and their effect on the mechanical properties (failure load and Young's modulus of elasticity) of tendons. It does not stand for the state-of-the-art of any single process. Based on a systematic literature review, we recommend freezing and gamma irradiation or electron beam at 14.8-28.5 kGy. These methods are effective at keeping or improving the mechanical properties, while fully sterilizing the inside and the outside of the tendon. Other sterilization method (ethylene oxide, supercritical carbon dioxide (SCCO2), BioCleanse) deteriorated the mechanical properties. These methods are not recommended.
Keywords: Biocleanse; Ebeam; Ethylene oxide; Gamma; Mechanical properties; SCCO2; Sterilization; Tendon.