Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

Completed · Not applicable

Conditions studied: Amputation

In brief

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.

Key facts

Study ID

NCT02886936

Run by

University of Pennsylvania

People needed

71

Starts

2018-05-01

Expected to finish

2022-05-31

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Penn Medicine Rittenhouse — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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