Abstract
Acellular xenogeneic tissues have the potential to provide ‘off‐the‐shelf’ grafts for anterior cruciate ligament (ACL) repair. To ensure that such grafts are sterile following packaging, it is desirable to use terminal sterilization methods. Here, the effects of gamma and electron beam irradiation on the biological and biomechanical properties of a previously developed acellular porcine superflexor tendon (pSFT) were investigated. Irradiation following treatment with peracetic acid was compared to peracetic acid treatment alone and the stability of grafts following long‐term storage assessed. Irradiation did not affect total collagen content or biocompatibility (determined using a contact cytotoxicity assay) of the grafts, but slightly increased the amount of denatured collagen in and decreased the thermal denaturation temperature of the tissue in a dose dependant fashion. Biomechanical properties of the grafts were altered by irradiation (reduced ultimate tensile strength and Young's modulus, increased failure strain), but remained superior to reported properties of the native human ACL. Long term storage at 4°C had no negative effects on the grafts. Of all the conditions tested, a dose of minimum 25 kGy of gamma irradiation had least effect on the grafts, suggesting that this dose produces a biocompatible pSFT graft with adequate mechanical properties for ACL repair. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 2477–2486, 2017.
Highlights
Damage to the anterior cruciate ligament (ACL) is increasingly common amongst a young and active population
The purpose of this study was to compare the biological and biomechanical properties of decellularized porcine superflexor tendon (pSFT) (d-pSFT) that had been treated with peracetic acid (PAA) to those treated with PAA before irradiation with one of several irradiation processes, including high (55 and 30 kGy gamma; 34 kGy E-beam) and low dose gamma and E-beam (15 kGy) and fractioned E-beam (15 1 15 kGy)
The presence of holes within the tissue was noted [34 kGy E-beam (34E), 15 kGy E-beam (15E), 15 1 15E (0M), and 30 kGy gamma (30G), 55 kGy gamma (55G), 15 1 15E and PAA (12M)]. This was usually limited to one region and sample per group, but for the 15 1 15E group at 12 months post-irradiation was observed in half of the samples
Summary
Damage to the anterior cruciate ligament (ACL) is increasingly common amongst a young and active population. For a severe ACL tear, there is a need to replace the ligament to restore stability within the joint. There are at least 100,000 ACL reconstructions performed per year in North America[1] and over 7000 per year in the UK.[2] Gold standard treatment for ACL reconstruction is the use of autograft or allograft tissues.[3] The surgical use of autograft has limitations including donor site morbidity,[4] leading to the increasing use of allografts.[5] Allografts are associated with prolonged periods of incorporation due to the presence of cellular components.[6] A promising alternative is the use of acellular allogeneic or xenogeneic tendon or ligament tissue for ACL reconstruction. Removal of immunogenic cells from such tissue has the potential to create a biocompatible decellularized biological scaffold which, once implanted, will not be subject to initial tissue degradation due to adverse immunological responses or graft necrosis and which will regenerate with the recipients endogenous cells over time.[7,8]
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