Comparing Endobutton CL BTB and Metal Interference Screws for Femoral Fixation in ACL Reconstruction Using Patellar Tendon Grafts

What this Trial Is About

Researchers are comparing two different methods for fixing a bone-patellar tendon-bone BPTB autograft during primary anterior cruciate ligament ACL reconstruction surgery. The study focuses on evaluating the Endobutton CL BTB Fixation System versus traditional metal interference screws for femoral fixation. This trial aims to determine differences in patient outcomes, graft healing, and risks associated with each method, as no previous randomized controlled trials have been done for these fixation techniques. Participants will be randomly assigned to receive either the Endobutton CL BTB device or a metal interference screw to secure the femoral side of the BPTB graft. Both groups will use metal interference screws for tibial fixation. Follow-up visits will take place at 6 weeks, 6 months, 2 years, and 10 years after surgery. A CT scan will assess bone block integration at 6 months, and X-rays will monitor osteoarthritis development at 2 and 10 years. Rehabilitation details will also be recorded during the study. Throughout the study, participants will undergo assessments including patient-reported outcomes focused on knee-related quality of life, knee laxity, muscle strength, range of motion, and functional scores. Multiple clinical tests and imaging techniques will be used to evaluate healing and joint health over time. The primary outcome is knee-related quality of life at 2 years, measured by the KOOS questionnaire. Participants who require revision surgery will be followed but excluded from further comparisons. The overall study period extends up to 10 years post-surgery.

Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws