Kirchdorf An Der Krems

Researchers are evaluating the Medacta Anatomic Ribbon Surgery (M-ARS) device for reconstructing the anterior cruciate ligament (ACL) in patients with ACL rupture. This observational study aims primarily to assess the survival rate of the M-ARS ACL implant six months after surgery. Additional goals include evaluating survival rates, clinical and functional outcomes, quality of life, and complication rates at 1 month, 1 year, and 2 years after surgery. The study involves a series of visits starting with a preoperative inclusion visit, followed by the ACL reconstruction surgery using the M-ARS device. Postoperative follow-up visits are scheduled at 1 month, 6 months, 12 months, and 24 months after surgery. Depending on standard practice, imaging may be done to assess implants and bone tunnels. Data will be collected electronically using a secure web-based system. Participants will undergo clinical and functional assessments using the International Knee Documentation Committee (IKDC) score and quality of life evaluations with the EQ-5D at multiple visits. The study will monitor implant survival by checking for failures such as revision or loosening, as well as any intraoperative or postoperative complications. Participants can withdraw from the study at any time. Statistical analysis will consider missing data as missing without imputation.