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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04791163

Acronym

P20-EMBSUBI

Enrollment

Registered

2021-03-10

Start date

2021-04-15

Completion date

2022-07-01

Last updated

2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Amputation Above Knee (Injury)

Brief summary

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

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.

Interventions

DEVICESocket evaluation

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Comfort evaluation	1 minute	Socket Comfort Score (SCS)

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026