[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659353":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":36,"studyPopulation":37,"armGroups":38,"interventions":32,"overallOfficials":32,"centralContacts":32,"locations":32,"responsibleParty":54,"collaborators":56,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":32,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":32,"enrollmentInfo":71,"targetDuration":32,"studyType":74,"phases":32,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":81,"whyStopped":32,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":32},{"fullName":5,"class":6},"MOVMEDIX","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"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.","10 years",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"Occurence of device deficiency","Description of device deficiencies occurring within 10 years post-procedure, related to the ligament reconstruction and\u002For fixation devices. Occurence by % on the total number of ligaments assessed.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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)",{"measure":27,"description":28,"timeFrame":12},"Knee function","Knee stability at 10 years measured with Lysholm score and International Knee Documentation Committee (IKDC) score .\n\nIKDC from 0 (unable to perform activity) to 4 (very demanding activity). Lysholm score is composed of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability) IKDC contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).",{"measure":30,"description":31,"timeFrame":12},"Knee stability","Knee stability at 10 years measured with Lysholm score section 4 and International Knee Documentation Committee (IKDC) score section 7.\n\nIKDC question 7 assess activity level with a 4 points item ranking from 0 (unable to perform activity) to 4 (very demanding activity).\n\nLysholm score section 4 assess knee stability on a 25 points item ranking from 0 (my knee gives way at every step )to 25 (my knee rarely gives way)",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","PROSPECTIVE","This is a multicenter observational PMCF study combining retrospective collection of historical clinical data with a prospective 10-year follow-up assessment, including a evaluation of device status, patient-reported outcomes and knee stability.","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.",[39,42,45,48,51],{"label":40,"type":32,"description":41,"interventionNames":32},"MCL32","Patients who received MCL32 ligament, 51 patients",{"label":43,"type":32,"description":44,"interventionNames":32},"ACL AC30DB\u002FAC60DB","Patients who received ACL AC30DB\u002FAC60DB ligament, 64 patients",{"label":46,"type":32,"description":47,"interventionNames":32},"ACL ACTOR8\u002FACTOR10","Patients who received ACL ACTOR8\u002FACTOR10 ligament, 64 patients",{"label":49,"type":32,"description":50,"interventionNames":32},"PCL PC60\u002FPC80","Patients who received PCL PC60\u002FPC80 ligament, 39 patients",{"label":52,"type":32,"description":53,"interventionNames":32},"PCL ACTOR8\u002FACTOR10","Patients who received PCL ACTOR8\u002FACTOR10 ligament, 39 patients",{"type":55,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[57,60],{"name":58,"class":59},"nexialist","UNKNOWN",{"name":61,"class":62},"1Med","OTHER","100659353","post-market-clinical-follow-up-of-lars-ligaments-associated-to-fixations-in-acute-or-chronic-injury-of-the-anterior-cruciate-ligament-acl-posterior-cruciate-pcl-or-medial-collateral-mcl-ligaments-of-the-knee-100659353",false,"NCT07864337","Post Market Clinical Follow-up of LARS® Ligaments Associated to Fixations in Acute or Chronic Injury of the Anterior Cruciate Ligament (ACL), Posterior Cruciate (PCL) or Medial Collateral (MCL) Ligaments of the Knee","Inclusion Criteria:\n\n1. Patient who received study information and provided informed consent to participate in the study, where required by applicable local regulations and ethics committee requirements.\n2. Patient who underwent ligamentoplasty using one or more LARS® artificial ligaments for posterior cruciate ligament (PCL), anterior cruciate ligament (ACL), and\u002For 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).\n3. Surgical procedure performed using LARS® ligaments in accordance with the intended use and routine clinical practice.\n4. Availability of adequate medical records and follow-up documentation allowing assessment of the study endpoints related to safety and performance\n\nExclusion Criteria:\n\n1. Patients aged less than 18 years at the time of the ligamentoplasty procedure.\n2. Patients presenting, at the date of surgery, with any contraindication to ligamentoplasty procedures and\u002For contraindications specified in the applicable Instructions for Use (IFU) of the implanted device.\n3. Patients who are lost to follow-up, deceased at the time of study conduct.\n4. Patients who have undergone bilateral ligamentoplasty.\n5. Patients belonging to a protected or vulnerable population, including individuals under guardianship, curatorship, legal protection measures, or any other condition limiting their ability to provide informed consent in accordance with applicable local regulations.\n6. Patients for whom the implanted ligament and\u002For associated fixation devices cannot be reliably identified from the available documentation.","ALL","18 Years",{"count":72,"type":73},257,"ESTIMATED","OBSERVATIONAL","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.",[77],"Knee Ligament Injury",[79,80],"LARS® ligament","Artificial knee ligament","NOT_YET_RECRUITING","2026-10-02",{"date":84,"type":85},"2026-10-07","ACTUAL",{"date":87,"type":73},"2026-12",{"date":89,"type":73},"2028-12",{"name":5,"class":6}]