Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets - Trial NCT06361966

Timeline & Enrollment

Primary Outcome

Prosthesis Evaluation Questionnaire,Socket Comfort Score

Summary

The goal of this clinical trial is to investigate the repeatability of application of a fully
 remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees,
 and determine user satisfaction of sockets produced through these methods. The study also
 aims to evaluate the time and cost effectiveness of this production model.
 
 The main question[s] it aims to answer are:
 
 1. To determine the repeatability and user satisfaction with transtibial sockets produced
 using a remote-digital method as compared to conventional manufacturing methods.
 
 2. To determine if transtibial prosthetic users have greater prosthetic satisfaction scores
 across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT),
 Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket
 fabricated through the remote-digital method compared to the laminate socket made using
 the conventional method.
 
 3. To determine if transtibial prosthetic users experience greater socket comfort with the
 3D printed socket compared to the laminate socket.
 
 Participants will receive a 3D printed socket (trial intervention) and a laminate socket
 (control intervention) and will use each socket for a period of 4 weeks.The order of socket
 use will be randomised. At the end of each 4 week period, participants will rate their
 comfort and satisfaction with the socket. At the end of the trial, participants will indicate
 their preferred socket, which will be fitted to their prosthesis.
 
 Participants will attend 6 visits across a total duration of 11 weeks during the course of
 the study.

ICD-10 Classifications