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

NCT06361966 | Completed

• 1 other identifier: 2021/00638
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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. 1.To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods.
2. 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. 3.To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket.

Conditions

Amputation; Prosthesis User

Keywords

transtibial amputation; transtibial prosthesis

Outcome Measures

Primary Outcomes (2)

• Prosthesis Evaluation Questionnaire

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

  after 4 weeks of socket use

• Socket Comfort Score

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

  at initial socket fitting and 4 weeks post-fitting

Study Arms (2)

Laminate socket

ACTIVE COMPARATOR

control intervention as standard treatment for transtibial amputees requiring a lower limb prosthesis

Device: 3d printed prosthetic socket

3d printed socket

EXPERIMENTAL

trial intervention for transtibial amputees requiring a lower limb prosthesis

Device: 3d printed prosthetic socket

Interventions

3d printed prosthetic socket DEVICE

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

3d printed socket; Laminate socket

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Prosfit Technologies JSC: collaborator
• Centre for Allied Health and Pharmacy Excellence (CAPE): collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Study Officials

• Tabitha Quake

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Prosthetist/Orthotist

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: January 11, 2022
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)