Status:
COMPLETED
Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment
Lead Sponsor:
Proteor Group
Conditions:
Lower Limb Amputation Above Knee (Injury)
Eligibility:
All Genders
18+ years
Phase:
NA
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-evaluat...
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 fou...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04791163
Start Date
April 15 2021
End Date
July 1 2022
Last Update
August 9 2022
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Les Capucins
Angers, France, 49100
2
UGECAM La Tour de Gassies
Bruges, France, 33523
3
Clinique du Cabirol
Colomiers, France, 31771
4
Hôpital Léon Bérard
Hyères, France, 83418