Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study

Conditions
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Lower Limb Amputation Above Knee (Injury)

Intervention / Treatment
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* Device: Socket evaluation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sub-ischial socket<br>Start using the sub-ischial socket for four weeks and be tested with this socket. | Device: Socket evaluation<br>* The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test<br>|
| Active Comparator: Ischial containment socket<br>Start using the ischial containment socket for four weeks and be tested with this socket. | Device: Socket evaluation<br>* The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort evaluation | Socket Comfort Score (SCS) | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort evaluation in various situations | Same question for four detailed situations | 1 minute | 
| Locomotor capability | PLUS-M questionnaire and 2-minute walking test | 5 minutes |