NCT02886936

Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2018-05-01
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2016-09-01
• Last updated: 2023-06-26
• Results posted: 2023-06-26

Locations

1 site across 1 country: United States