Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

University of Pennsylvania

Status: Completed

Conditions: Amputation

Treatments: Device: iFIT Transtibial Prosthesis; Device: iFIT Transfemoral Prosthesis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02886936

815654

2R42AG050430 (U.S. NIH Grant/Contract)

2SB1AG050430-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

iFIT Prosthetics, LLC® created and commercialized a modular, immediate fit, fully adjustable, prosthetic system suitable for mass production using high strength injection molded polymer materials. The aim of this project is to assess the design, user satisfaction and feasibility of this device. The investigators will be fitting transtibial and transfemoral amputees with the iFIT prosthetic system. Patients will wear the device for 2 weeks in order to compare the device to their own prosthetic (if they currently have one). They will report any device breakages or adverse events. They will also fill out a questionnaire to determine if the iFIT prosthetic is a feasible option for treating patients with limb loss.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• transtibial or transfemoral level of amputation
• functional ambulator with or without a cane
• six months or more since amputation.

Exclusion criteria

• patient have skin ulcerations on the residual limb
• have other central nervous system disorders such as strokes and brain injuries that interfere with safe ambulation and gait testing
• severe phantom or limb pain
• weight over 260 lbs

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Transtibial Testing

Experimental group

Description:

This is a feasibility and effectiveness study to assess the iFIT transtibial prosthesis as a viable alternative to a traditional prosthesis. We also hope to gain information that will influence future design iterations.

Treatment:

Device: iFIT Transtibial Prosthesis

Transfemoral Testing

Experimental group

Description:

This is a feasibility and effectiveness study to assess the iFIT transfemoral prosthesis as a viable alternative to a traditional prosthesis. We also hope to gain information that will influence future design iterations.

Treatment:

Device: iFIT Transfemoral Prosthesis