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Improving Prosthetic Care for Patients With a Lower Limb Amputation

NCT03517774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-07-09

No results posted yet for this study

Summary

Adults with lower limb amputation undergo rehabilitation in order to learn how to effectively use a lower limb prosthesis. Unfortunately, the process of being fitted a prosthesis can be delayed due to resource constraints and manufacturing times, which delays the rehabilitation process and puts patients at higher risk for functional decline. Preliminary work by our team have shown that our 3D printing system, 3DPrintAbility Devices by NIA (http://niatech.org/), perform at the same level of efficacy as traditionally manufactured prosthetics, which suggests that a digital manufacturing tool-chain is a viable alternative and may be desirable given the time savings involved. In order to lead to improved processes related to prosthesis fitting for adult transtibial amputees, we want to assess the feasibility and acceptability of using 3DPrintAbility sockets in this population. Specifically, we want to determine if: 1) the 3D printing of transtibial prosthetic sockets can provide better quality prosthetic care in regards to cost, timeliness, and accessibility; 2) 3D printed sockets are equivalent in quality to standard thermoplastic preparatory sockets in regards to safety, fit, durability and comfort; and 3) whether a 3D scanning, design and printing process can be integrated into the workflow of current rehab centres. If successful, the findings from this work can provide an innovative approach for facilitating the fitting of a socket for adults with amputation might provide significant savings to the healthcare system by making the process more efficient while optimizing clinical outcomes by allowing patients to begin their rehabilitation sooner

Conditions

  • Amputation

Interventions

DEVICE

3D Printed Socket

Twenty participants will be fitted with a 3D Printed socket created using 3DPrintAbility hardware and software. To do this, a 3D model of the participants residual limb will be generated which will be used to create the 3D printed sockets. These 20 participants will also receive standard care for prosthetic fitting at SJR. The fittings will be done by one prosthetist. Our team will compare the feasibility, function, quality and stability of the prosthetics through quantitative, economic and qualitative analyses. All fittings will be done under the supervision of a qualified Sunnybrook prosthetist who has previous experience with using 3D printed technologies for creation of prosthetics.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Amanda Mayo, MD; MHSc · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-03-04
Completion
2021-03-04

Countries

  • Canada

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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 NCT03517774 on ClinicalTrials.gov