This study aims to assess the long-term safety, stability, knee function, pain, and satisfaction of patients who received a LARS® ligament to treat an injury of one of the main ligaments of the knee.
Patient who received study information and provided informed consent to participate in the study, where required by applicable local regulations and ethics committee requirements.
Patient who underwent ligamentoplasty using one or more LARS® artificial ligaments for posterior cruciate ligament (PCL), anterior cruciate ligament (ACL), and/or medial collateral ligament (MCL) in only 1 leg (knee) reconstruction between 2015 and 2018 (or since 9 to 12 years from data collection time-point).
Surgical procedure performed using LARS® ligaments in accordance with the intended use and routine clinical practice.
Availability of adequate medical records and follow-up documentation allowing assessment of the study endpoints related to safety and performance
Patients aged less than 18 years at the time of the ligamentoplasty procedure.
Patients presenting, at the date of surgery, with any contraindication to ligamentoplasty procedures and/or contraindications specified in the applicable Instructions for Use (IFU) of the implanted device.
Patients who are lost to follow-up, deceased at the time of study conduct.
Patients who have undergone bilateral ligamentoplasty.
Male or female patient who underwent ligamentoplasty in 1 Knee (1leg) using one or more LARS® artificial ligaments, with or without associated fixation devices between 2015 and 2018.
Cohort
Prospective
Not listed
Device failure proportion
The primary safety endpoint is the proportion of knees with a device failure at 10 years post-procedure. Device failure is defined as implant removal for any aseptic reason, including implant rupture.
Occurence of knee-related adverse events
Perioperative and postoperative related to ligaments or fixations or instruments up to 10 years postoperatively. Occurence by % on the total number of ligaments assessed.
Occurence of device deficiency
Description of device deficiencies occurring within 10 years post-procedure, related to the ligament reconstruction and/or fixation devices. Occurence by % on the total number of ligaments assessed.
Occurence of reintervention
Description of reintervention occurring within 10 years post-procedure, related to any cause, without device removal. Occurence by % on the total number of ligaments assessed.
Pain level
Pain level at 10 years measured by Knee injury and Osteoarthritis Outcome Score (KOOS) with pain subscore. It is composed on 9 questions. Each item is evaluated on 4 points ranking from 0 (none pain) to 4 (extreme pain)
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This trial is not recruiting at the moment. You can still explore other options:
