Evaluation of Medacta Anatomic Ribbon Surgery M-ARS for ACL Reconstruction Assessing Implant Survival and Patient Outcomes over 2 Years

What this Trial Is About

Researchers are evaluating the performance of Medacta Anatomic Ribbon Surgery M-ARS in patients who need anterior cruciate ligament ACL reconstruction. This observational study aims to assess the survival rate of the M-ARS ACL implant at 6 months after surgery. It also looks at the implants survival, clinical and functional outcomes, quality of life, and complication rates at 1 month, 1 year, and 2 years post-operation. Participants will undergo the M-ARS ACL procedure, which reconstructs the ACL using the Anatomic Ribbon Technique. The study includes a preoperative visit for consent and information, followed by surgery, then scheduled follow-up visits at 1 month, 6 months, 12 months, and 24 months after surgery. Imaging assessments of the implant and bone tunnels may be done according to standard practice. During the study, researchers will collect data on implant survival by monitoring for failures such as revision or loosening. They will evaluate clinical and functional outcomes using the International Knee Documentation Committee IKDC score, quality of life with the EQ-5D score, and record any intraoperative and postoperative complications. Data are collected electronically, and participants can withdraw at any time. The study lasts up to two years post-surgery with multiple follow-up visits to track progress.

M-ARS ACL Post-marketing Surveillance Study