[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557039":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":42,"studyPopulation":43,"armGroups":44,"interventions":86,"overallOfficials":38,"centralContacts":108,"locations":114,"responsibleParty":257,"collaborators":38,"id":259,"slug":38,"hasResults":260,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":38,"eligibilityCriteria":264,"healthyVolunteers":260,"sex":265,"minAge":266,"maxAge":38,"enrollmentInfo":267,"targetDuration":38,"studyType":270,"phases":38,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":138,"whyStopped":38,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":294},{"fullName":5,"class":6},"Teknimed","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluation of join function","Function will be evaluated from standardized and validated clinical questionnaires, with few questions relative to domains such as pain, mobility, range of motion... which are specific for one joint","4 years (until the lifetime of the device)",{"measure":14,"description":15,"timeFrame":16},"Adverse event","Adverse event related to sports surgery products","5 years",[18,22,25,28,31,34],{"measure":19,"description":20,"timeFrame":21},"Pain level","Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits","4 years",{"measure":23,"description":24,"timeFrame":21},"Antalgic consumption","Antalgic consumption and the drug type at the Baseline and at the Follow-up visits",{"measure":26,"description":27,"timeFrame":21},"Patients' satisfaction","Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes\u002FNo\u002FWithout opinion) at the Follow-up visits",{"measure":29,"description":30,"timeFrame":21},"Quality of patient life","Quality of patient life assessed using Well-Being questionnaire (6 questions with a scale of 0 to 10, with 0 being not at all and 10 being the better response at the Baseline and at the Follow-up visits)",{"measure":32,"description":33,"timeFrame":21},"Radiological outcomes","Evaluation of implants integrity\u002F resorption Bioresorbable screws, pins and anchors will be classified as \"degraded\", \"partially intact\" or \"intact\", as observed on imaging exam.",{"measure":35,"description":36,"timeFrame":37},"Devices and instrumentations usability","Instrumentations usability assessed by physician evaluation of the sucessive phases of surgery.\n\nThe physician is asked to evaluate the successive phases of the surgery to assess the global device usability. For each technical phase, he has to choose between 3 propositions: Easy, Difficult or Impossible. At the end of the surgical procedure, the surgeon is asked to assess the resulting joint stability (stable or unstable).","Once, during surgery",null,{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":40,"timePerspective":41,"maskingInfo":38},"COHORT","OTHER","It is admitted that:\n\n* Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction,\n* Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures, osteotomies, arthrodesis and bone grafts of toes,\n* Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures,\n* Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis.\n\nFurthermore, resorption properties of many available devices (screws, pins) that are marketed as bioabsorbable may be different and not always very well defined.\n\nThis retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use.\n\nStudied products include - but are not restricted to - the following TEKNIMED products:\n\n* EUROSCREW® NG\n* ISOFIX®\n* SUTUR'LINK®\n* A'LINK'S®\n* BIORESORBABLE PINS\n\nAnd following associated TEKNIMED instrumentation:\n\n* ACL Instrumentation\n* A'LINK'S® Instrumentation\n* STAINLESS STEEL PINS","People suffering from tears or ruptures of ligaments or tendons and in need of an orthopaedic surgery, according to the specific intended uses related to each device.",[45,50,54,59,63,67,71,76,81],{"label":46,"type":38,"description":47,"interventionNames":48},"EUROSCREW NG PLA knee (ACL) surgery","Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA",[49],"Device: Orthopaedic surgeries (knee)",{"label":51,"type":38,"description":52,"interventionNames":53},"EUROSCREW NG PLA knee (PCL) surgery","Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA",[49],{"label":55,"type":38,"description":56,"interventionNames":57},"EUROSCREW NG PLA ankle surgery","Patients included for ankle surgery with EUROSCREW NG PLA",[58],"Device: Orthopaedic surgeries (ankle)",{"label":60,"type":38,"description":61,"interventionNames":62},"EUROSCREW NG PLA\u002FTCP knee (ACL) surgery","Patients included for anterior crucial ligament of knee surgery with EUROSCREW NG PLA\u002FTCP",[49],{"label":64,"type":38,"description":65,"interventionNames":66},"EUROSCREW NG PLA\u002FTCP knee (PCL) surgery","Patients included for posterior crucial ligament of knee surgery with EUROSCREW NG PLA\u002FTCP",[49],{"label":68,"type":38,"description":69,"interventionNames":70},"ISOFIX knee (ACL) surgery","Patients included for anterior crucial ligament of knee surgery with ISOFIX",[49],{"label":72,"type":38,"description":73,"interventionNames":74},"A'LINK'S shoulder surgery","Patients included for shoulder surgery with A'LINK'S",[75],"Device: Orthopaedic surgeries (shoulder)",{"label":77,"type":38,"description":78,"interventionNames":79},"SUTUR'LINK surgery","Patients included for surgery with SUTUR'LINK",[80],"Device: Orthopaedic surgeries",{"label":82,"type":38,"description":83,"interventionNames":84},"PINS foot surgery","Patients included for foot surgery with PINS",[85],"Device: Orthopaedic surgeries (foot)",[87,92,96,100,104],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":38},"DEVICE","Orthopaedic surgeries (ankle)","ankle lateral ligament reconstruction in ligamentoplasty procedures",[55],{"type":88,"name":93,"description":94,"armGroupLabels":95,"otherNames":38},"Orthopaedic surgeries (shoulder)","rotator cuff repair",[72],{"type":88,"name":97,"description":98,"armGroupLabels":99,"otherNames":38},"Orthopaedic surgeries (knee)","knee cruciate ligaments reconstruction in ligamentoplasty procedures",[46,51,60,64,68],{"type":88,"name":101,"description":102,"armGroupLabels":103,"otherNames":38},"Orthopaedic surgeries","rotator cuff repair or closure of capsule after arthroplasty surgery",[77],{"type":88,"name":105,"description":106,"armGroupLabels":107,"otherNames":38},"Orthopaedic surgeries (foot)","stabilization of metatarsal and phalangeal osteotomies during treatment of hallux",[82],[109],{"name":110,"role":111,"phone":112,"phoneExt":38,"email":113},"Solange VAN DE MOORTELE, PhD","CONTACT","+33 5 34 25 26 79","s.vandemoortele@teknimed.com",[115,136,151,161,176,191,206,217,232,242],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"Milaire","NOT_YET_RECRUITING","Aubenas","Ardèche","07200","France","FR",{"type":124,"coordinates":125},"Point",[126,127],4.39033,44.61975,{"lat":127,"lon":126},[130,134],{"name":131,"role":111,"phone":132,"phoneExt":38,"email":133},"Michel MILAIRE, MD","04 75 35 70 00","michel.milaire@yahoo.com",{"name":131,"role":135,"phone":38,"phoneExt":38,"email":38},"PRINCIPAL_INVESTIGATOR",{"facility":137,"status":138,"city":139,"state":119,"zip":140,"country":121,"countryCode":122,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Centre Claude Bernard","RECRUITING","Guilherand-Granges","07500",{"type":124,"coordinates":142},[143,144],4.87372,44.93278,{"lat":144,"lon":143},[147,150],{"name":148,"role":111,"phone":38,"phoneExt":38,"email":149},"Richard PHILIPPE, MD","richard.philippe@ccb07.org",{"name":148,"role":135,"phone":38,"phoneExt":38,"email":38},{"facility":152,"status":138,"city":139,"state":119,"zip":140,"country":121,"countryCode":122,"cosmosGeoPoint":153,"geoPoint":155,"contacts":156},"Centre Mistral -Clinique Pasteur",{"type":124,"coordinates":154},[143,144],{"lat":144,"lon":143},[157,160],{"name":158,"role":111,"phone":38,"phoneExt":38,"email":159},"Grégory NAVEZ, MD","gregory.navez@gmail.com",{"name":158,"role":135,"phone":38,"phoneExt":38,"email":38},{"facility":162,"status":138,"city":163,"state":164,"zip":165,"country":121,"countryCode":122,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Orthopole des 3 provinces","Brive-la-Gaillarde","Corrèze","19100",{"type":124,"coordinates":167},[168,169],1.53326,45.1589,{"lat":169,"lon":168},[172,175],{"name":173,"role":111,"phone":38,"phoneExt":38,"email":174},"Alain HARISBOURE, MD","a.harisboure@orthocedres19.fr",{"name":173,"role":135,"phone":38,"phoneExt":38,"email":38},{"facility":177,"status":138,"city":178,"state":179,"zip":180,"country":121,"countryCode":122,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Clinique Pasteur","Bergerac","Dordogne","24100",{"type":124,"coordinates":182},[183,184],0.48171,44.85157,{"lat":184,"lon":183},[187,190],{"name":188,"role":111,"phone":38,"phoneExt":38,"email":189},"Carlos FERRER, MD","carlos.ferrer@hotmail.fr",{"name":188,"role":135,"phone":38,"phoneExt":38,"email":38},{"facility":192,"status":138,"city":193,"state":194,"zip":195,"country":121,"countryCode":122,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Médipôle Toulouse","Toulouse","Haute-Garonne","31100",{"type":124,"coordinates":197},[198,199],1.44367,43.60426,{"lat":199,"lon":198},[202,205],{"name":203,"role":111,"phone":38,"phoneExt":38,"email":204},"Christophe JAVOIS, MD","christophe.javois@yahoo.fr",{"name":203,"role":135,"phone":38,"phoneExt":38,"email":38},{"facility":207,"status":208,"city":209,"state":210,"zip":211,"country":121,"countryCode":122,"cosmosGeoPoint":212,"geoPoint":216,"contacts":38},"Clinique Chénieux","COMPLETED","Limoges","Haute-Vienne","87000",{"type":124,"coordinates":213},[214,215],1.24759,45.83362,{"lat":215,"lon":214},{"facility":218,"status":138,"city":219,"state":220,"zip":221,"country":121,"countryCode":122,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Clinique St Privat","Boujan-sur-Libron","Hérault","34760",{"type":124,"coordinates":223},[224,225],3.24749,43.37082,{"lat":225,"lon":224},[228,231],{"name":229,"role":111,"phone":38,"phoneExt":38,"email":230},"Guillaume MIROUSE, MD","gmirouse@gmail.com",{"name":229,"role":135,"phone":38,"phoneExt":38,"email":38},{"facility":233,"status":234,"city":235,"state":220,"zip":236,"country":121,"countryCode":122,"cosmosGeoPoint":237,"geoPoint":241,"contacts":38},"Clinique Via Domitia","ACTIVE_NOT_RECRUITING","Lunel","34400",{"type":124,"coordinates":238},[239,240],4.13611,43.67778,{"lat":240,"lon":239},{"facility":243,"status":138,"city":244,"state":245,"zip":246,"country":121,"countryCode":122,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Clinique Esquirol Saint-Hilaire","Agen","Lot-et-Garonne","47000",{"type":124,"coordinates":248},[249,250],0.62055,44.20199,{"lat":250,"lon":249},[253,256],{"name":254,"role":111,"phone":38,"phoneExt":38,"email":255},"Damien LAQUES, MD","damien.laques@wanadoo.fr",{"name":254,"role":135,"phone":38,"phoneExt":38,"email":38},{"type":258,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100557039",false,"NCT06532929","Sport Surgery Products Outcomes - A Post-market Follow-up","Safety and Clinical Performance Assessment of Sport Surgery Products - A Post-market Clinical Follow-up","Inclusion Criteria:\n\n* Be 18 years or older.\n* Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France)\n\nFor prospective inclusion:\n\n\\- Be considered for a surgery with one of the TEKNIMED sports surgery product comprised in this study.\n\nFor retrospective inclusion:\n\n* Have undergone a surgery with a TEKNIMED sports surgery product between the 1st January 2016 and the date of the site initiation visit.\n* Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).\n\nExclusion Criteria:\n\n* Patients presenting one of the following conditions will not be included: under trusteeship or guardianship, pregnancy\n* Anyone of the contraindications mentioned in the respective IFU of each device under study","ALL","18 Years",{"count":268,"type":269},390,"ESTIMATED","OBSERVATIONAL","Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products. TEKNIMED has developed several devices currently used in orthopaedic surgery. With the increasing use of these procedures, there is a need for real-life long-term safety and efficacy data on these products.\n\nThe study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.",[273],"Sport Surgery",[275,276,277,278,279,280,281,282,283,284],"knee","shoulder","sport","surgery","suture","ligamentoplasty","anchors","screw","resorbable","pins","2025-03-24",{"date":287,"type":288},"2025-03-27","ACTUAL",{"date":290,"type":288},"2019-11-01",{"date":292,"type":269},"2036-11",{"name":5,"class":6},10]