Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Osseointegrated Transtibial Prosthesis With Neural Interface

NCT05249049

Amputation

UNKNOWN NA

In Vivo Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant

NCT01882751

Complications; Arthroplasty

COMPLETED

Air Barrier System for the Prevention of Prosthesis-related Infections

NCT02376153

Prosthesis-Related Infections

UNKNOWN NA

Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees

NCT06391697

Amputation

ACTIVE_NOT_RECRUITING NA

Active Knee Prosthesis Study

NCT06700668

Transfemoral Amputation

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amputation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

single-group pre-post intervention study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transtibial Testing

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.

Group Type EXPERIMENTAL

iFIT Transtibial Prosthesis

Intervention Type DEVICE

Transtibial 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.

Transfemoral Testing

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.

Group Type EXPERIMENTAL

iFIT Transfemoral Prosthesis

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iFIT Transtibial Prosthesis

Transtibial 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.

Intervention Type DEVICE

iFIT Transfemoral Prosthesis

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No