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

Lower Limb Amputation Above Knee (Injury) Clinical Trial

— P20-EMBSUBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791163
• Other study ID #: 2020-A03303-36
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: Proteor Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lower Limb Amputation Above Knee (Injury)

Intervention

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

Locations

Country	Name	City	State
France	Les Capucins	Angers
France	UGECAM La Tour de Gassies	Bruges
France	Clinique du Cabirol	Colomiers
France	Hôpital Léon Bérard	Hyères
France	UGECAM - IRR Nancy	Nancy
France	Institution Nationale des Invalides	Paris
France	Centre Mutualiste de Kerpape	Ploemeur
France	UGECAM La Tourmaline	Saint-Herblain
France	CHBA Vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Proteor Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort evaluation	Socket Comfort Score (SCS)	1 minute
Secondary	Comfort evaluation in various situations	Same question for four detailed situations	1 minute
Secondary	Locomotor capability	PLUS-M questionnaire and 2-minute walking test	5 minutes