Low Cost Socket for Lower Limb Amputees

NACompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

July 6, 2018

Primary Completion Date

January 11, 2024

Study Completion Date

January 1, 2025

Conditions
AmputationAmputation; Traumatic, LimbAmputation, Traumatic
Interventions
DEVICE

Low cost lower limb prosthetic socket

"A pre-made 3D printed cylinder used as an outer shell is selected for each subject based on their measurements. The space between the residual limb and the outer shell will be filled with an expanding polyurethane foam (Foam IT 8, Smooth On Inc.) that conforms to the residual limb and bonds with the outer shell to form a strong and lightweight socket. The foam forms a smooth surface against the protective sheath; the socket is fully formed once the foam has hardened to the 3D printed cylinder.~A prefabricated supracondylar suspension cuff made of Dacron or nylon, or a commercially available suspension sleeve may be will be applied to the prosthetic socket to aid in suspension. Commercially available components, including the International Committee of the Red Cross (ICRC) transtibial polypropylene component system will be attached to the bottom of the socket to allow the patient to ambulate in the prosthesis."

Trial Locations (1)

60611

Shirley Ryan AbilityLab, Chicago

All Listed Sponsors
lead

Shirley Ryan AbilityLab

OTHER

NCT04725461 - Low Cost Socket for Lower Limb Amputees | Biotech Hunter | Biotech Hunter