[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518724":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":31,"responsibleParty":77,"collaborators":19,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":19,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":19,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"TBF Genie Tissulaire","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SclerFIX-IP","EXPERIMENTAL","Treated, devitalised and sterile graft of umbilical cord amniotic membrane",[13],"Biological: SclerFIX-IP",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the PIPJ",[9],null,[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Laurence BARNOUIN, MD","CONTACT","4 72 68 69 09","+33","laurence.barnouin@tbf-lab.com",{"name":28,"role":23,"phone":29,"phoneExt":25,"email":30},"Justine BOSC, MSc","4 72 68 69 11","justine.bosc@tbf-lab.com",[32,50,64],{"facility":33,"status":34,"city":35,"state":19,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"CHU de Besançon","RECRUITING","Besançon","25030","France","FR",{"type":40,"coordinates":41},"Point",[42,43],6.01815,47.24878,{"lat":43,"lon":42},[46,48],{"name":47,"role":23,"phone":19,"phoneExt":19,"email":19},"François LOISEL, MD",{"name":47,"role":49,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"facility":51,"status":34,"city":52,"state":19,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Institut Chirurgical de la Main et du Membre Supérieur","Lyon","69006",{"type":40,"coordinates":55},[56,57],4.84789,45.74906,{"lat":57,"lon":56},[60,63],{"name":61,"role":23,"phone":19,"phoneExt":19,"email":62},"Lionel ERHARD, MD","lionel.erhard@institut-chirurgical.com",{"name":61,"role":49,"phone":19,"phoneExt":19,"email":19},{"facility":65,"status":34,"city":66,"state":19,"zip":67,"country":37,"countryCode":38,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Centre de la Main - Clinique Jules Verne","Nantes","44300",{"type":40,"coordinates":69},[70,71],-1.55336,47.21725,{"lat":71,"lon":70},[74,76],{"name":75,"role":23,"phone":19,"phoneExt":19,"email":19},"Edward de KEATING-HART, MD",{"name":75,"role":49,"phone":19,"phoneExt":19,"email":19},{"type":78,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100518724","phase-2-use-of-a-treated-devitalized-and-sterile-umbilical-cord-amniotic-membrane-in-the-treatment-of-pip-joint-osteoarthritis-100518724",false,"NCT06034262","Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis","Evaluation of the Treatment of Symptomatic Proximal InterPhalangeal (PIP) Joint Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition","Inclusion Criteria:\n\n* Male or female; age between 18 and 75 years.\n* Patient with symptomatic PIPJ OA.\n* Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.\n* Patient with a QuickDash score \\> 33 points (converted to 50%).\n* Patient with pain, at rest, in the PIPJ ≥ 4\u002F10 on a VAS.\n* Patient who received the study information and provided consent.\n* Member or beneficiary of a national health insurance plan.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman; woman without effective contraception.\n* Patient with signs of neuropathy with functional disorders such as hyperesthesia.\n* Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.\n* Person confined by a judicial or administrative decision.\n* Adult subjected to legal protection measures or unable to provide his\u002Fher consent.","ALL","18 Years","75 Years",{"count":90,"type":91},14,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of PIP joint osteoarthritis.",[97],"Osteoarthritis Hand",[99,100],"Proximal InterPhalangeal Joint (PIPJ)","OsteoArthritis (OA)","2025-09-24",{"date":103,"type":104},"2025-09-26","ACTUAL",{"date":106,"type":104},"2024-10-07",{"date":108,"type":91},"2026-01",{"name":5,"class":6},3]