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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-07-01

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.

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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.

Conditions

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Lower Limb Amputation Above Knee (Injury)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sub-ischial socket

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

Group Type EXPERIMENTAL

Socket evaluation

Intervention Type DEVICE

The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test

Ischial containment socket

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

Group Type ACTIVE_COMPARATOR

Socket evaluation

Intervention Type DEVICE

The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test

Interventions

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Socket evaluation

The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No