NCT06361966

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

Completed NA Last updated 12 April 2024

What this trial tests

NA trial testing 3d printed prosthetic socket in Amputation in 16 participants. Completed in 9 January 2023.

Timeline

11 January 2022

Primary endpoint
9 January 2023

9 January 2023

Quick facts

Lead sponsor	Tan Tock Seng Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	11 January 2022
Primary completion	9 January 2023
Estimated completion	9 January 2023
Sites	1 location across Singapore

Drugs / interventions tested

• 3d printed prosthetic socket

Conditions studied

• Amputation — all drugs for Amputation →
• Prosthesis User — all drugs for Prosthesis User →

Sponsor

Tan Tock Seng Hospital

Who can join

Adults 21 to 99, any sex, with Amputation or Prosthesis User. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.