Improving Prosthetic Care for Patients With a Lower Limb Amputation

NCT03517774 | Completed

• 1 other identifier: MaRS 3D-Printing
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Time to Complete Prosthetic Process - SCIL Form

  Details the clinical, technical, and offsite time for the production and fitting of sockets for amputee patients. The broad categories of tasks captured include: 1) preparation \& assessment; 2) shape capture; 3) shape capture to rectification; 4) rectification (modifying); and 5) fabrication. Time will be captured in hours.

  Immediately post intervention

• Costs Associated with Prosthetic Process - SCIL Form

  The various costs associated with each task (materials, clinician hourly rate, etc.) will also be recorded.

  Immediately post intervention

Secondary Outcomes (2)

• Satisfaction with Socket Ratings

  Immediately post intervention

• Comfort With Socket Ratings

  Immediately post intervention

Study Arms (1)

3D Printed Socket

EXPERIMENTAL

All participants will received a 3D Printed Prosthetic

Device: 3D Printed Socket

Interventions

3D Printed Socket DEVICE

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.

3D Printed Socket

Eligibility Criteria

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

You may qualify if:

• Current SJR in-patient or out-patient who will be receiving a prosthetic for a LLA;
• Must be medically cleared to participate in the study;
• Fluent in English with no cognitive impairments (ex. clinical depression, brain injury) in order to complete the informed consent process and qualitative interview.

You may not qualify if:

• Those who are not medically cleared to participate in the study
• Have significant cognitive, developmental or language impairments (including a lack of fluency in English)
• Persons who do not have a trans-tibial amputation (i.e., partial foot, transfemoral, etc.).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

St. John's Rehabilitation

North York, Ontario, M2M 2G1, Canada

Location

Related Publications (1)

• Mayo AL, Gould S, Cimino SR, Glasford S, Harvey E, Ratto M, Hitzig SL. A qualitative study on stakeholder perceptions of digital prosthetic socket fabrication for transtibial amputations. Prosthet Orthot Int. 2022 Dec 1;46(6):607-613. doi: 10.1097/PXR.0000000000000157. Epub 2022 Jun 7.

  PMID: 36515905 DERIVED

Study Officials

• Amanda Mayo, MD; MHSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: May 7, 2018
• Study Start: May 1, 2018
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)