Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis

Recruiting now · Not applicable

Conditions studied: Transtibial Amputation, Lower Limb Amputation Below Knee

In brief

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 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.

Key facts

Study ID

NCT07592325

Run by

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

People needed

25

Starts

2026-04-27

Expected to finish

2027-10-30

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hôpital National d'Instruction des Armées (HNIA) Percy — Clamart, France (enrolling)
• Hôpital Filieris de Freyming-Merlebach — Freyming-Merlebach, France (enrolling)
• CHU Grenoble Alpes - Hôpital Sud — Grenoble, France (enrolling)
• Institut Régional de Médecine Physique et de Réadaptation (IRR) - Filière Locomoteur — Nancy, France (enrolling)
• Insititution Nationale des Invalides — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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