Socket Geometry and Clinical Outcomes of Manual vs Digital Sockets for Lower-limb Amputees

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 10, 2021

Primary Completion Date

November 30, 2023

Study Completion Date

November 30, 2023

Conditions
Amputation
Interventions
DEVICE

3D-printed socket

During the shape-capturing in-patient appointment, participants will be measured for the prosthetic device through (1) manual casting using Plaster of Paris bandages and (2) scanning using a 3D scanner. The clinician will manually modify the positive plaster cast and digitally modify the scanned impression using OMEGA software. The manually-modified positive cast will be digitized by scanning the cast, then 3D-printed. The digitally-modified socket file will also be 3D printed. The research investigator will make a de-identified mark on each socket to differentiate between the two sockets after 3D printing, and will record the order in which the sockets are fit to the patient.

Trial Locations (1)

M6M 2J5

West Park Healthcare Centre, Toronto

All Listed Sponsors
lead

West Park Healthcare Centre

OTHER

NCT06504303 - Socket Geometry and Clinical Outcomes of Manual vs Digital Sockets for Lower-limb Amputees | Biotech Hunter | Biotech Hunter