Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 1:27 AM
Study NCT ID:
NCT06361966
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets
Sponsor:
Tan Tock Seng Hospital
Organization:
Study Overview
Official Title:
Evaluating User Satisfaction and Feasibility of a Remote-digital Model for 3d Scanning and Printing of Prosthetic Sockets for Patients With Transtibial Amputation: A Preliminary Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
The visit schedule for the study is as follows:
* Visit 1 (Week 0): Attain consent and initiate casting and scanning process for 1 laminate and 1 3D printed transtibial socket
* Visit 2 (Week 3): Fitting and adjustment of first prosthetic socket (either 3D printed or laminate socket). Subjects to rate comfort of first socket.
* Visit 3 (Week 5): Follow-up on any required device adjustments/ troubleshooting to first socket.
* Visit 4 (Week 7): Evaluation of user satisfaction with first socket. Subjects to fill up survey on first socket. Fitting of other socket design (second socket). Subjects to rate comfort of second socket.
* Visit 5 (Week 9): Follow-up on any required device adjustments/ troubleshooting to second socket.
* Visit 6 (Week 11): Evaluation of user satisfaction with second socket. Subjects to fill up survey on second socket and select their preferred socket. Fitting of patient's preferred socket to prosthesis.
* Visit 1 (Week 0): Attain consent and initiate casting and scanning process for 1 laminate and 1 3D printed transtibial socket
* Visit 2 (Week 3): Fitting and adjustment of first prosthetic socket (either 3D printed or laminate socket). Subjects to rate comfort of first socket.
* Visit 3 (Week 5): Follow-up on any required device adjustments/ troubleshooting to first socket.
* Visit 4 (Week 7): Evaluation of user satisfaction with first socket. Subjects to fill up survey on first socket. Fitting of other socket design (second socket). Subjects to rate comfort of second socket.
* Visit 5 (Week 9): Follow-up on any required device adjustments/ troubleshooting to second socket.
* Visit 6 (Week 11): Evaluation of user satisfaction with second socket. Subjects to fill up survey on second socket and select their preferred socket. Fitting of patient's preferred socket to prosthesis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: