OrthoPureXT is an acellular, sterile, single use, xenograft (porcine) tissue scaffold that is manufactured using a proprietary decellularisation technology that renders the tissue substantially free from cells, leaving the porcine tissue biocompatible, and safe for implantation into the knee.~28 patients in total to be evenly distributed across potential ligament reconstruction treatment options (n=7 per sub-group) and resulting in a statistically relevant number per sub-group considering potential loss to follow up.~Sub-groups of n=7 incurring ligament reconstruction using OrthoPure XT in the following anatomical locations:~Posterior cruciate ligament (PCL)~Anterior cruciate ligament (ACL)~Posteromedial corner including the medial collateral ligament (MCL)~Posterolateral corner including the lateral collateral ligament (LCL)
To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.