Comparison of Human Allograft Cortical Bone Screw and Biocomposite Interference Screws for ACL Reconstruction A Prospective Randomized Controlled Trial Measuring Bone Tunnel Widening and Knee Function

What this Trial Is About

This trial studies adults with anterior cruciate ligament ACL rupture who need reconstructive surgery. It compares two types of screws used for fixing the graft during ACL reconstruction a human allogeneic cortical bone screw called Shark Screw ACL and a conventional biocomposite screw Mecta. The goal is to see if the bone screw reduces bone tunnel widening and lowers the rate of graft re-rupture. Knee function scores before and after surgery are also recorded to assess outcomes. Participants undergo ACL reconstruction with either the allogeneic bone screw or the biocomposite screw. The surgical technique is the same for both groups, including arthroscopic confirmation of diagnosis, tendon preparation, bone tunnel creation, graft insertion, and fixation with the assigned interference screw. The tibial bone tunnel is filled with cancellous chips, and graft stability is checked before wound closure. Participants have MRIs before surgery, within 3 days after surgery, and at 6, 12, and 24 months post-surgery. CT scans are done immediately after surgery, and at 6 and 24 months. Knee scores IKDC, KOOS, Lysholm, Tegner are collected before surgery and at 6, 12, and 24 months. The study measures bone tunnel widening in millimeters over time and evaluates graft incorporation, safety, and knee function. Total participation lasts 24 months after surgery.

ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws