Multiligament Knee Injuries Clinical Trial
Official title:
Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series
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.
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) ;