Abstract

To avoid the risk of infectious disease transmission from donor to recipient, allografts should be terminally sterilized. In the previous paper (Kaminski et al. in Cell Tissue Bank 10:215–219, 2009) we presented the effect of various methods of preservation (deep fresh freezing, glycerolization, lyophilization), followed by irradiation with different doses of electron beam (EB), on material (intrinsic) mechanical properties of human patellar tendons cut out as for anterior cruciate ligament reconstruction, obtained in failure tensile test. As structural mechanical properties are equally important to predict the behaviour of the graft as a whole functional unit, the purpose of the present paper was to show the results for failure load and elongation, obtained in the same experiment. Paired Bone-Tendon-Bone grafts (BTB) were prepared from cadaveric human patella tendons with both patellar and tibial attachments. They were preserved by deep freezing, glycerolization or lyophilization and subsequently EB-irradiated with the doses of 25, 35, 50 or 100 kGy (fresh-frozen grafts) or a single dose of 35 kGy (glycerolized and lyophilized grafts). Each experimental (irradiated) group was provided with control (non-irradiated), donor-matched group. The specimens from all groups were subjected to mechanical failure tensile test with the use of Instron system in order to measure their structural properties (failure load and elongation). All lyophilized grafts were rehydrated before mechanical testing. In our study we did not observe significant deterioration of structural mechanical properties of BTB grafts processed by fresh-freezing and then terminal sterilized with growing doses of EB up to 100 kGy. In contrast, BTB grafts processed by glycerolization or lyophilization and irradiated with 35 kGy showed significant decrease of failure load. Obtained results suggest that deep-frozen irradiated grafts retain their initial mechanical properties to an extent which does not exclude their clinical application. However, biomechanical investigations constitute only the first step to evaluate the potential clinical usefulness of such allografts and further extensive in vivo studies are needed.

Highlights

  • The anterior cruciate ligament (ACL) is essential for maintaining the stability of the knee, in activities involving cutting, pivoting and kicking (Mohtadi et al 2011)

  • The prerequisite justifying direct evaluation of Bone-Tendon-Bone grafts (BTB) allograft structural mechanical properties was met in our experiment

  • Special clamps for bone attachments applied in our study to fix BTB allografts on testing machine enabled the observation of the mechanism of specimen failure during tensile test

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Summary

Introduction

The anterior cruciate ligament (ACL) is essential for maintaining the stability of the knee, in activities involving cutting (sudden change in direction), pivoting and kicking (Mohtadi et al 2011). To avoid the potential of infectious disease transmission from a donor to a recipient (Eastlund 2006; Segur et al 1998; Bohatyrewicz et al 2006; Ireland and Spelman 2005; Schubert et al 2012; Terzaghi et al 2015; McDermott and Thomas 2005) and ensure their microbial safety (Sterility Assurance Level 10-6), allografts should be radiation sterilized with gamma radiation or accelerated electron beam (EB), usually with the doses of 25 or 35 kGy. In recently published retrospective analysis of bone and tendon allografts, obtained from 196 organ and tissue donors between 2008 and 2011, the overall incidence of bacteriological contamination was 23 % (Terzaghi et al 2015), whereas in other studies it ranged from 5.8 % for musculoskeletal allografts (Ireland and Spelman 2005) to 48 % for bone allografts from cadaveric donors (Bohatyrewicz et al 2006). These data clearly indicate the importance of terminal sterilization of tissue allografts procured from cadaveric donors

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