A novel silk-based artificial ligament and tricalcium phosphate/polyether ether ketone anchor for anterior cruciate ligament reconstruction - Safety and efficacy in a porcine model

Loss of ligament graft tension in early postoperative stages following anterior cruciate ligament (ACL) reconstruction can come from a variety of factors, with slow graft integration to bone being widely viewed as a chief culprit. Toward an off-the-shelf ACL graft that can rapidly integrate to host tissue, we have developed a silk-based ACL graft combined with a tricalcium phosphate (TCP)/polyether ether ketone anchor. In the present study we tested the safety and efficacy of this concept in a porcine model, with postoperative assessments at 3 months (n = 10) and 6 months (n = 4). Biomechanical tests were performed after euthanization, with ultimate tensile strengths at 3 months of ∼370 N and at 6 months of ∼566 N - comparable to autograft and allograft performance in this animal model. Comprehensive histological observations revealed that TCP substantially enhanced silk graft to bone attachment. Interdigitation of soft and hard tissues was observed, with regenerated fibrocartilage characterizing a transitional zone from silk graft to bone that was similar to native ligament bone attachments. We conclude that both initial stability and robust long-term biological attachment were consistently achieved using the tested construct, supporting a large potential for silk-TCP combinations in the repair of the torn ACL.