Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

Sponsor

University of Pennsylvania (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02886936

Collaborator

iFIT Prosthetics, LLC (Other), National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Amputation	Device: iFIT Prosthesis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

single-group pre-post intervention studysingle-group pre-post intervention study

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

Actual Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iFIT Group This is a feasibility and effectiveness study to assess the iFIT transtibial and transfemoral prosthesis as a viable alternative to a traditional prosthesis. We also hope to gain information that will influence future design iterations.	Device: iFIT Prosthesis Transtibial and transfemoral amputee volunteers will be fit with the iFIT device and instructed on its use. Patient will wear the iFIT device for a two week time period according to a provided wear schedule. At the end of this time patient will rate it for comfort, stability and ease of use.

Arm

Intervention/Treatment

Experimental: iFIT Group

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

Device: iFIT Prosthesis

Transtibial and transfemoral amputee volunteers will be fit with the iFIT device and instructed on its use. Patient will wear the iFIT device for a two week time period according to a provided wear schedule. At the end of this time patient will rate it for comfort, stability and ease of use.

Outcome Measures

Primary Outcome Measures

Questionnaire [2 weeks]
Participants will fill out an evaluation on their current prosthesis, and the iFIT prosthesis after a two week time interval. The questionnaire intends to compare the immediate fit prosthesis to the conventional prosthetic to determine if it is a feasible alternative for persons with limb loss.

Secondary Outcome Measures

Number of participants with device related adverse events [2 weeks]
We will record any unfavorable events such that occur including: skin irritation, skin breakdown, falls, or mechanical failures.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn Medicine Rittenhouse	Philadelphia	Pennsylvania	United States	19146

Sponsors and Collaborators

University of Pennsylvania
iFIT Prosthetics, LLC
National Institute on Aging (NIA)

Investigators

Principal Investigator: Timothy Dillingham, MD, MS, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT02886936

Other Study ID Numbers:

815654
2R42AG050430
2SB1AG050430-06

First Posted:

Sep 1, 2016

Last Update Posted:

Sep 23, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Pennsylvania

transtibial

transfemoral

Study Results

No Results Posted as of Sep 23, 2021