[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626433":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":20,"eligibilityCriteria":29,"healthyVolunteers":25,"sex":30,"minAge":31,"maxAge":32,"enrollmentInfo":33,"targetDuration":20,"studyType":36,"phases":37,"briefSummary":39,"conditions":40,"keywords":42,"overallStatus":44,"whyStopped":20,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":20},{"fullName":5,"class":6},"TBF Genie Tissulaire","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SclerFIX","EXPERIMENTAL","Treated amniotic membrane of umbilical cord allograft",[13],"Procedure: with SclerFIX",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","with SclerFIX","Use of the treated umbilical cord amniotic membrane allograft SclerFIX as an interposition implant in the TMC joint",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100626433","phase-2-use-of-a-treated-devitalized-and-sterile-umbilical-cord-amniotic-membrane-in-the-treatment-of-trapeziometacarpal-osteoarthritis-100626433",false,"NCT07435571","Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis","Evaluation of the Treatment of Trapeziometacarpal Osteoarthritis (TMC OA) With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition","Inclusion Criteria:\n\n* Patient presenting with symptomatic osteoarthritis of the trapeziometacarpal joint, with wrist pain ≥ 40\u002F100 according to the PRWE pain subscale (scaled to 100).\n* Patient who has received medical treatment for functional symptoms for more than 3 months without improvement, and for whom surgical intervention is indicated.\n* Patient with radiographic stage I-II trapeziometacarpal joint osteoarthritis according to the Eaton-Glickel classification.\n* Patient able to understand, date, and sign the informed consent form.\n* Patient affiliated with a social security system or beneficiary of such a system.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman ; woman without effective contraception.\n* Patient with scaphotrapeziotrapezoid (STT) joint osteoarthritis requiring prosthetic surgical treatment.\n* Patient with thumb osteoarthritis secondary to a systemic inflammatory disease (e.g., rheumatoid arthritis).\n* Patient with osteoarthritis experiencing an acute inflammatory flare, characterized by a warm, painful, and swollen joint at the time of enrollment.\n* Patient with amputated hand(s).\n* Patient presenting signs of neuropathy with functional impairment such as hyperesthesia. Neuropathy may be peripheral (nerve injury) or systemic (caused by diabetes or excessive alcohol consumption).\n* Patient lacking capacity to participate in rehabilitation or to comply with study follow-up.\n* Patient with a contraindication to anesthesia (poorly controlled epilepsy, neuropathy, etc.).\n* Person deprived of liberty by a judicial or administrative decision.\n* Adult subject under legal protection or unable to provide informed consent.","ALL","18 Years","75 Years",{"count":34,"type":35},22,"ESTIMATED","INTERVENTIONAL",[38],"PHASE2","The objective of this clinical trial is to evaluate whether a human umbilical cord amniotic membrane allograft can serve as an interposition implant in the surgical treatment of trapeziometacarpal osteoarthritis.\n\nThe main question this study aims to address is :\n\n\\- Can interposition of a human umbilical cord amniotic membrane within the trapeziometacarpal joint reduces postoperative pain and improves thumb mobility, grip and pinch strength, and overall wrist function.\n\nParticipant will:\n\n* Undergo surgical treatment of the trapeziometacarpal osteoarthritis with the interposition in articular joint of an amniotic membrane of umbilical cord allograft on Day 0\n* Visit the center for a series of tests 1 month, 3 months, 6 months and 12 months after the surgical intervention.",[41],"Trapeziometacarpal Osteoarthritis",[43],"TMC OA","NOT_YET_RECRUITING","2026-02-20",{"date":47,"type":48},"2026-02-27","ACTUAL",{"date":50,"type":35},"2026-03",{"date":52,"type":35},"2028-03",{"name":5,"class":6}]