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

Not Applicable

Completed

• Conditions: Lower Limb Amputation Above Knee (Injury)
• Interventions: Device: Socket evaluation

• Registration Number: NCT04791163
• Lead Sponsor: Proteor Group

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.

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Study Start: 2021-04-15
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ischial containment socket	Socket evaluation	Start using the ischial containment socket for four weeks and be tested with this socket.
Sub-ischial socket	Socket evaluation	Start using the sub-ischial socket for four weeks and be tested with this socket.

Primary Outcome Measures

Name	Time	Method
Comfort evaluation	1 minute	Socket Comfort Score (SCS)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Centre Mutualiste de Kerpape; 🇫🇷 Ploemeur, France

UGECAM - IRR Nancy; 🇫🇷 Nancy, France

Institution Nationale des Invalides; 🇫🇷 Paris, France

Clinique du Cabirol; 🇫🇷 Colomiers, France

UGECAM La Tourmaline; 🇫🇷 Saint-Herblain, France

Les Capucins; 🇫🇷 Angers, France

UGECAM La Tour de Gassies; 🇫🇷 Bruges, France

Hôpital Léon Bérard; 🇫🇷 Hyères, France

CHBA Vannes; 🇫🇷 Vannes, France