[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100346972":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":80,"collaborators":25,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":25,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Percutaneous needle aponeurotomy","EXPERIMENTAL","It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure. End of treatment will be considered as the last session of needle aponeurotomy.",[13],"Procedure: Percutaneous needle aponeurotomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Open surgery with limited aponeurectomy","ACTIVE_COMPARATOR","It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy). End of surgical treatment will be considered as the removal of the stitches (two weeks after the surgical treatment).",[19],"Procedure: Open surgery with limited aponeurectomy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy)",[15],[30],{"name":31,"affiliation":32,"role":33},"Johann BEAUDREUIL, PUPH","APHP","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+33 1 49 95 88 28","johann.beaudruil@aphp.fr",[40,53,59,69],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":25},"Centre d'Imagerie Médicale Bachaumont Paris Centre","ACTIVE_NOT_RECRUITING","Paris","75002","France","FR",{"type":48,"coordinates":49},"Point",[50,51],2.3488,48.85341,{"lat":51,"lon":50},{"facility":54,"status":42,"city":43,"state":25,"zip":55,"country":45,"countryCode":46,"cosmosGeoPoint":56,"geoPoint":58,"contacts":25},"Hopital LARIBOISIERE - Radiologie","75010",{"type":48,"coordinates":57},[50,51],{"lat":51,"lon":50},{"facility":60,"status":61,"city":43,"state":25,"zip":55,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Hopital LARIBOISIERE - Rhumatologie","RECRUITING",{"type":48,"coordinates":63},[50,51],{"lat":51,"lon":50},[66],{"name":31,"role":36,"phone":67,"phoneExt":25,"email":68},"01 49 95 88 28","johann.beaudreuil@aphp.fr",{"facility":70,"status":61,"city":43,"state":25,"zip":71,"country":45,"countryCode":46,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur","75016",{"type":48,"coordinates":73},[50,51],{"lat":51,"lon":50},[76],{"name":77,"role":36,"phone":78,"phoneExt":25,"email":79},"ERIC ROULOT, PH","01 42 15 42 33","secretaire.roulot@gmail.com",{"type":81,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100346972","effectiveness-of-percutaneous-needle-aponeurotomy-100346972",false,"NCT03797690","Effectiveness of Percutaneous Needle Aponeurotomy","Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator","EFAPAD","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Ascertained Dupuytren disease: palpable fibrotic nodule or cord developed from the palmar aponeurosis, flexion contracture of a metacarpophalangeal or proximal interphalangeal joint.\n* Presence of at least one flexion contracture of a metacarpophalangeal joint of the hand due to Dupuytren's disease and \\> or = 20°\n* Written informed consent signed by the patient\n* Patient affiliated to the social security\n\nExclusion Criteria:\n\n* Presence of other musculoskeletal disorders of the hand than Dupuytren's disease: known inflammatory rheumatic disease of the hand, clinical signs of inflammatory rheumatic disease of the hand, MP or PIP pain at inclusion visit.\n* Previous surgery of the hand to be treated resulting in functional limitation or limitation of finger mobility\n* Any other pathological condition or limited range of motion in the finger to be treated\n* Psychiatric status precluding patient evaluation; vulnerable persons; adults under legal protection order or incompetent, physically or mentally incapable of giving his consent.\n* Pregnant or beastfeeding women\n* Participation in another interventional trial","ALL","18 Years",{"count":93,"type":94},120,"ESTIMATED","INTERVENTIONAL",[97],"NA","The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's disease.\n\nOur hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.",[100],"Dupuytren Disease of Finger",[102,9,103,104],"Dupuytren's disease","Limited aponeurectomy","Randomized trial","2025-04-01",{"date":107,"type":108},"2025-04-02","ACTUAL",{"date":110,"type":108},"2020-11-02",{"date":112,"type":94},"2029-02-14",{"name":5,"class":6},4]