[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571709":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":27,"responsibleParty":44,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":19,"overallStatus":30,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"TBF Genie Tissulaire","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AMTRIX-D","EXPERIMENTAL","Surgical release of the tendon and wrapping of the released tendon with desiccated amniotic membrane (AMTRIX-D)",[13],"Biological: AMTRIX-D",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Use of a decellularized, viro-inactivated, desiccated, and sterile allogeneic amniotic membrane graft to wrap a tendon after release of its adhesions.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Justine BOSC, MSc","CONTACT","4 72 68 69 11","+33","justine.bosc@tbf-lab.com",[28],{"facility":29,"status":30,"city":31,"state":19,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Institut Chirurgical de la Main et du Membre Supérieur","RECRUITING","Lyon","69006","France","FR",{"type":36,"coordinates":37},"Point",[38,39],4.84789,45.74906,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":19,"phoneExt":19,"email":19},"Lionel ERHARD, MD",{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100571709","phase-2-surgical-release-of-hand-tendons-with-wrapping-of-the-released-tendon-using-an-amniotic-membrane-100571709",false,"NCT06723782","Surgical Release of Hand Tendons with Wrapping of the Released Tendon Using an Amniotic Membrane","Inclusion Criteria:\n\n* Man or woman aged 18 to 65 years old\n* Adhesion of a flexor and\u002For extensor tendon of the hand.\n* Adhesion localized to a single finger.\n* Adhesion that has been present for at least 3 months following primary repair, despite high-quality rehabilitation. Primary repair is defined as the repair of a tendon injury, fracture, crush injury of the finger, infection, etc., leading to the adhesion of the tendon to surrounding tissue.\n* Patient with a total passive range of motion of the proximal and distal interphalangeal joints of at least 150°.\n* Informed and consenting patient.\n* Patient enrolled in a social security plan or a beneficiary of such a plan.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman, or without an effective method of contraception.\n* Patient requiring tenolysis after tendon grafting for the reconstruction of a deep common flexor or after reimplantation.\n* Patient with amputated hand(s).\n* Patient with an untreated fracture or non-union in the affected hand.\n* Patient requiring multiple surgical interventions that may be potential confounding factors, particularly those involving additional incisions.\n* Patient unable to understand rehabilitation or follow the study protocol.\n* Patient with a contraindication to anesthesia.\n* Person deprived of liberty by judicial or administrative decision.\n* Adult subject to legal protection measures or incapable of expressing consent.","ALL","18 Years","65 Years",{"count":56,"type":57},16,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","The goal of this clinical trial is to evaluate whether an amniotic membrane can function as an effective anti-adhesive barrier following surgical release of tendon adhesions. The main question the clinical trial aims to answer is:\n\n\\- Can wrapping an amniotic membrane around a surgically released tendon help reduce recurrence of adhesions and promote recovery of hand functionality?\n\nParticipants will:\n\n* Undergo surgical treatment (surgical release of the tendon adhesions and wrapping of the amniotic membrane around the release tendon) on Day 0.\n* Visit the center for a series of tests 15 days, 6 weeks, 3 months, 6 months after the surgical intervention.",[63,64],"Tendon Adhesion","Tenolysis","2024-12-04",{"date":67,"type":68},"2024-12-09","ACTUAL",{"date":70,"type":68},"2024-02-15",{"date":72,"type":57},"2026-08",{"name":5,"class":6},1]