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

NCT06361966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-04-12

No results posted yet for this study

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.

Conditions

  • Amputation
  • Prosthesis User

Interventions

DEVICE

3d printed prosthetic socket

3d printed prosthetic socket produced through multi-jet fusion (MJF)

Sponsors & Collaborators

  • Prosfit Technologies JSC

    collaborator UNKNOWN

  • Centre for Allied Health and Pharmacy Excellence (CAPE)

    collaborator UNKNOWN

  • Tan Tock Seng Hospital

    lead OTHER

Principal Investigators

  • Tabitha Quake · Tan Tock Seng Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2023-01-09
Completion
2023-01-09

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06361966 on ClinicalTrials.gov