Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis

ConditionsTranstibial Amputation Lower Limb Amputation Below Knee

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unilateral or bilateral transtibial amputation

Currently fitted with a definitive carbon rigid socket

Any residual-limb shape

Any etiology

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Access Socket (AS)
Device
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.
Rigid Socket (RS)
Device
Conventional definitive carbon-fiber rigid socket, currently the only socket type reimbursed in France for transtibial amputation (LPPR-listed). Standard of care comparator.

Treatment groups

25 Participants

are divided into 2 treatment groups

Group A: Group 1 (RS -> AS)Active comparator 2 interventions

Group B: Group 2 (AS -> RS)Active comparator 2 interventions

Trial outcomes

Primary outcomes

Patient Specific Functional Scale (PSFS) score

Patient-centered self-report tool. The patient identifies 3-5 specific activities they have difficulty performing, then rates their ability on a 0-10 scale (0 = unable to perform, 10 = able to perform at pre-injury level). The final score is the mean of the ratings

Time frame