[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638105":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":127,"collaborators":129,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":25,"enrollmentInfo":154,"targetDuration":25,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (RS -> AS)","ACTIVE_COMPARATOR","Participants wear their standard rigid socket (RS) for 4 weeks, complete evaluation, then switch to the Access Socket (AS) for 1-2 weeks of adaptation followed by 4 weeks of wear, with a second evaluation.",[13,14],"Device: Access Socket (AS)","Device: Rigid Socket (RS)",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2 (AS -> RS)","Participants receive the Access Socket (AS) first, with 1-2 weeks of adaptation followed by 4 weeks of wear and evaluation. They then switch to the standard rigid socket (RS) for 1-2 weeks of adaptation and 4 weeks of wear, with a second evaluation.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Access Socket (AS)","Hybrid prosthetic socket combining a rigid carbon-fiber structure in load-bearing areas (lateral, postero-inferior, inferior) with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. Manufactured from the same plaster mold as the rigid socket to ensure identical internal geometry.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Rigid Socket (RS)","Conventional definitive carbon-fiber rigid socket, currently the only socket type reimbursed in France for transtibial amputation (LPPR-listed). Standard of care comparator.",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Isabelle Loiret, MD","Institut Régional de Médecine Physique et de Réadaptation (IRR), Nancy, France","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+33383529950","isabelle.loiretpro@gmail.com",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Jonathan Pierret, PhD","jonathan.pierret@ugecam.assurance-maladie.fr",[44,63,79,98,113],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hôpital National d'Instruction des Armées (HNIA) Percy","RECRUITING","Clamart","92140","France","FR",{"type":52,"coordinates":53},"Point",[54,55],2.26692,48.80299,{"lat":55,"lon":54},[58,62],{"name":59,"role":37,"phone":60,"phoneExt":25,"email":61},"Marie Thomas-Pohl, MD","+33 1.41.46.62.82","marie.thomas@intradef.gouv.fr",{"name":59,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":64,"status":46,"city":65,"state":25,"zip":66,"country":49,"countryCode":50,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Hôpital Filieris de Freyming-Merlebach","Freyming-Merlebach","57804",{"type":52,"coordinates":68},[69,70],6.78333,49.15,{"lat":70,"lon":69},[73,77],{"name":74,"role":37,"phone":75,"phoneExt":25,"email":76},"Catherine Achour, MD","+33 3 83 52 98 61","catherine.achour@filieris.fr",{"name":78,"role":34,"phone":25,"phoneExt":25,"email":25},"Catherine Achour",{"facility":80,"status":46,"city":81,"state":25,"zip":82,"country":49,"countryCode":50,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"CHU Grenoble Alpes - Hôpital Sud","Grenoble","38434",{"type":52,"coordinates":84},[85,86],5.71479,45.17869,{"lat":86,"lon":85},[89,93,95],{"name":90,"role":37,"phone":91,"phoneExt":25,"email":92},"Solène Maret, MD","+33 4 76 76 60 25","smaret2@chu-grenoble.fr",{"name":94,"role":34,"phone":25,"phoneExt":25,"email":25},"Solène MAret, MD",{"name":96,"role":97,"phone":25,"phoneExt":25,"email":25},"Phillipe Escobar, MD","SUB_INVESTIGATOR",{"facility":99,"status":46,"city":100,"state":25,"zip":101,"country":49,"countryCode":50,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Institut Régional de Médecine Physique et de Réadaptation (IRR) - Filière Locomoteur","Nancy","54000",{"type":52,"coordinates":103},[104,105],6.18496,48.68439,{"lat":105,"lon":104},[108,111,112],{"name":109,"role":37,"phone":75,"phoneExt":25,"email":110},"Christelle REQUENA","christelle.requena@ugecam.assurance-maladie.fr",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":114,"status":46,"city":115,"state":25,"zip":116,"country":49,"countryCode":50,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Insititution Nationale des Invalides","Paris","75007",{"type":52,"coordinates":118},[119,120],2.3488,48.85341,{"lat":120,"lon":119},[123],{"name":124,"role":37,"phone":125,"phoneExt":25,"email":126},"Joseph Bascou, PhD","+33 3 87 51 30 30","joseph.bascou@invalides.fr",{"type":128,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[130,132,134,136,138,141,143],{"name":131,"class":6},"Institution Nationale des Invalides",{"name":64,"class":133},"UNKNOWN",{"name":135,"class":133},"Ortho Access",{"name":137,"class":133},"H20 Orthopedie",{"name":139,"class":140},"Otto Bock France SNC","INDUSTRY",{"name":142,"class":133},"Hôpital d'Instruction des armées Percy",{"name":144,"class":133},"Clinical Investigation Center - University Hospital Grenoble","100638105","clinical-evaluation-of-the-access-socket-flexible-socket-for-transtibial-prosthesis-100638105",false,"NCT07592325","Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis","AS-TT","Inclusion Criteria:\n\n* Unilateral or bilateral transtibial amputation\n* Currently fitted with a definitive carbon rigid socket\n* Any residual-limb shape\n* Any etiology\n* Able to understand simple instructions, read, write, and provide informed consent - or able to be accompanied by a trusted person in case of inability to read\u002Fwrite autonomously\n* Provided free written informed consent\n* Aged 18 years or older\n* Affiliated to a social security system\n\nExclusion Criteria:\n\n* Use of hydroalcoholic solution (HAS) for socket donning\n* Currently fitted with a provisional socket\n* Neurological pathology limiting capacity to participate in activities\n* Orthopedic pathology limiting capacity to participate in activities\n* Pregnant or breastfeeding women\n* Minors\n* Persons not under legal protection or unable to express consent\n* Persons under guardianship or curatorship\n* Persons under judicial protection","ALL","18 Years",{"count":155,"type":156},25,"ESTIMATED","INTERVENTIONAL",[159],"NA","Transtibial amputation significantly impacts patient autonomy and quality of life, primarily due to the limitations of conventional rigid sockets, which restrict comfort and joint range of motion. The Access Socket (AS) is an innovative prosthetic socket combining a rigid carbon-fiber structure in key load-bearing areas with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. This hybrid design aims to improve comfort and pressure distribution while preserving the mechanical properties required for ambulation.\n\nThe AS has already demonstrated benefits in transfemoral amputees and is now reimbursed in France for that population. A preliminary uncontrolled study in 12 transtibial amputees suggested significant improvements in perceived function, comfort, satisfaction, and mobility.\n\nThis multicenter, randomized, open-label, two-arm crossover study aims to compare the (AS) with the standard rigid socket (RS) in 25 adults with transtibial amputation. Participants will wear each socket for approximately 4 weeks (after a 1-2 week adaptation period) in a randomized order. The primary outcome is the Patient Specific Functional Scale (PSFS). Secondary outcomes include comfort (SCS), satisfaction (OPUS), psychosocial adjustment (TAPES-R), mobility (PLUS-M), prosthesis utility (PEQ-U), and the proportion of patients electing to keep the AS at study completion.",[162,163],"Transtibial Amputation","Lower Limb Amputation Below Knee",[165,166,167,168,169,170,171,172,173],"Transtibial prosthesis","Prosthetic socket","Flexible socket","Access Socket","Comfort","Quality of life","Rehabilitation","cross over trial","Patient Specific Scale","2026-05-13",{"date":176,"type":177},"2026-05-18","ACTUAL",{"date":179,"type":177},"2026-04-27",{"date":181,"type":156},"2027-10-30",{"name":5,"class":6},5]