Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment (P20-EMBSUBI)

Proteor Group

Status: Completed

Conditions: Lower Limb Amputation Above Knee (Injury)

Treatments: Device: Socket evaluation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04791163

2020-A03303-36

Details and patient eligibility

About

Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.

Full description

Subjects wearing ischail containment sockets will be proposed to enter the research. They will be provided and fitted with a sub-ischial socket. Randomly, they will use one or the other socket for four weeks, then be tested : finctional test and questionnaires. After this testing session, they will use the other socket, and be re-tested accordingly.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• can give informed consent
• aged 18 or more
• above-knee amputee, wearing a definitive ischial containment socket
• stump longer than 16cm
• wearing a liner, whatever the suspension system
• able to walk (d4600, d4601, d4602, d4608 accordinf to IFC)
• unilaterla or bilateral amputee
• able to done the socket standing
• whatever the etiology

Exclusion criteria

• protected person
• pregnant woman or nursing mother
• subject having comorbidities heavily impacting feeling or socket donning
• allergic to silicon
• suffering from big volume variations in a same day
• infecté stump (may lead to lymphatic problems)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

25 participants in 2 patient groups

Sub-ischial socket

Experimental group

Description:

Start using the sub-ischial socket for four weeks and be tested with this socket.

Treatment:

Device: Socket evaluation

Ischial containment socket

Active Comparator group

Description:

Start using the ischial containment socket for four weeks and be tested with this socket.

Treatment:

Device: Socket evaluation