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NCT Number: NCT06361966

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

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.

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Key information

Conditions

Amputation Prosthesis User

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore, 308433

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral transtibial amputation, current transtibial prosthetic users minimally capable of community ambulation (mobility grades K2 - K4) who have completed gait training, current users of a roll on elastomeric or silicone liner system, and aged 21 years old and above to be able to provide informed consent.

Exclusion criteria

  • Functional status: patients with severe aphasia or neglect (inability to obey 1 step commands), communication disorders precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
  • Mobility status: patients who are non-community ambulators (mobility grade K1) or who have not completed gait training
  • Active limb conditions: uncontrolled lower limb volume fluctuations, severe stump varus or valgus deformities and/or lower limb contractures of over 10 degrees, or with local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas, active arthritis or joint or limb pain.
  • Reproductive age females should not be pregnant during the study.

Treatment and study plan

3d printed prosthetic socket

Device

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

Primary outcomes

  1. Prosthesis Evaluation Questionnaire

    Time frame: after 4 weeks of socket use

    Subscales of Utility, Appearance, Sounds and Residual Limb Health, and an individual satisfaction question

  2. Socket Comfort Score

    Time frame: at initial socket fitting and 4 weeks post-fitting

    Self-reported socket comfort is rated from 0 - 10, where 0 is the most uncomfortable socket imaginable and 10 the most comfortable.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • Centre for Allied Health and Pharmacy Excellence (CAPE)
  • Prosfit Technologies JSC

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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