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Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis

RecruitingNAAges 18 Years - anyAllUnion de Gestion des Etablissements des Caisses d…
NCT07592325 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The 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. This multicenter, randomized, open-label, two-arm crossover stud

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📋 Eligibility rules (as published)
Inclusion Criteria: * Unilateral or bilateral transtibial amputation * Currently fitted with a definitive carbon rigid socket * Any residual-limb shape * Any etiology * 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/write autonomously * Provided free written informed consent * Aged 18 years or older * Affiliated to a social security system Exclusion Criteria: * Use of hydroalcoholic solution (HAS) for socket donning * Currently fitted with a provisional socket * Neurological pathology limiting capacity to participate in activities * Orthopedic pathology limiting capacity to participate in activities * Pregnant or breastfeeding women * Minors * Persons not under legal protection or unable to express consent * Persons under guardianship or curatorship * Persons under judicial protection
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What it tests

  • Access Socket (AS)
  • Rigid Socket (RS)
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Where

5 sites
Hôpital National d'Instruction des Armées (HNIA) Percy
Clamart, France
Hôpital Filieris de Freyming-Merlebach
Freyming-Merlebach, France
CHU Grenoble Alpes - Hôpital Sud
Grenoble, France
Institut Régional de Médecine Physique et de Réadaptation (IRR) - Filière Locomoteur
Nancy, France
Insititution Nationale des Invalides
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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