Biological and biomechanical evaluation of the ligament advanced reinforcement system (LARS AC) in a sheep model of anterior cruciate ligament replacement: a 3-month and 12-month study.

PURPOSE The purposes of this study were to assess tissue ingrowth within the Ligament Advanced Reinforcement System (LARS) artificial ligament (LARS AC; LARS, Arc sur Tille, France) and to study the biomechanical characteristics of the reconstructed knees in a sheep model of anterior cruciate ligament (ACL) replacement. METHODS Twenty-five female sheep underwent excision of the proximal third of the left ACL and intra-articular joint stabilization with a 44-strand polyethylene terephthalate ligament (mean ultimate tensile failure load, 2,500 N). Animals were killed either 3 or 12 months after surgery. Explanted knees were processed for histology (n = 10) or mechanical tests including tests of laxity and loading to failure in tension (n = 15). RESULTS Well-vascularized tissue ingrowth within the artificial ligament was only observed in the portions of the ligament in contact with the host's tissues (native ligament and bone tunnels). Ligament wear was observed in 40% of explanted knees. The ultimate tensile failure loads of the operated knees at both time points were inferior to those of the contralateral, intact knees (144 ± 69 N at 3 months and 260 ± 126 N at 12 months versus 1,241 ± 270 N and 1,218 ± 189 N, respectively) (P < .01). In specimens with intact artificial ligaments, failure occurred by slippage from the bone tunnels in all specimens explanted 3 months postoperatively and in half of the specimens explanted 12 months postoperatively. CONCLUSIONS This study provides evidence that the LARS AC has a satisfactory biointegration but that it is not suitable for ACL replacement if uniform tissue ingrowth is contemplated. Despite good clinical performance up to 1 year after implantation, none of the reconstructions approached the mechanical performance of the normal ACL in the ovine model. Partial tearing of the artificial ligament, which led to a significant decrease in ultimate tensile strength, was observed in 40% of cases in the ovine model. CLINICAL RELEVANCE The LARS is not a suitable scaffold for ACL replacement. Further animal studies are needed to evaluate its potential for augmentation of ligament repair.