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Single-Subject Research Design on 3D-Printed Prosthetic Sockets

NCT07329738 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-01-09

No results posted yet for this study

Summary

The goal of this single-subject research design (clinical trial) is to assess the functionality of the 3D printed prostheses and to compare them to the existing prostheses in terms of mobility, balance, utility, and comfort. Participants who have a unilateral or bilateral transtibial amputation wear their existing prosthesis for roughly 3 weeks, followed by 3 weeks wearing a 3D printed prosthesis. The research assistants collect data throughout each period remotely, with the exception of one in-person visit to participants' homes to prepare the setting for the virtual evaluation sessions.

Conditions

  • Transtibial Amputees

Interventions

DEVICE

3D printed prosthetic sockets

The sockets are 3D printed using Polyethylene Terephthalate Glycol (PETG) filament. The printer used for this process is the Fused Deposition Modelling (Creality Ender 6), equipped with a 1.0 mm nozzle diameter, a print speed of 45mm/s, and a layer thickness of 2 mm. To enhance their strength, the sockets are reinforced with Delta-Lite® plus cast tapes and assembled using a distal push-lock mechanism and plate. The number of reinforcement wraps of the Delta-Lite® differs for each region of the socket. Below the sockets, the same prosthetic components from the previous prosthesis are utilized where possible. Participants wear their 3D printed sockets for an adjustment period (3-7 days) and then come in for a follow-up session to ensure the 3D socket still fits well after their limb has settled into the new system. Once both the prosthetist and participant are happy with the fit, Phase B testing is scheduled.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • William C. Miller · University of British Columbia

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2025-01-24
Completion
2026-03-11

Countries

  • Canada

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 NCT07329738 on ClinicalTrials.gov