Immediate Fit Using Innovative Technology Transtibial Prosthesis
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | May 1, 2019 |
| End Date: | May 31, 2020 |
| Contact: | Timothy R Dillingham, MD, MS |
| Email: | timothy.dillingham@uphs.upenn.edu |
| Phone: | 414-333-1658 |
The goal of iFIT Prosthetics, LLC® was to create and commercialize a modular, immediate fit,
fully adjustable, transtibial prosthesis system suitable for mass production using high
strength injection molded polymer materials. This goal was achieved and the aim of this
project is now to conduct a feasibility and effectiveness study and to assess the design of
the device. The investigators will be fitting up to 50 transtibial amputees that are current
prosthesis users with the iFIT device. Patients will wear the device for 1 month and evaluate
for comfort, stability and ease of use as compared to their conventional device.
fully adjustable, transtibial prosthesis system suitable for mass production using high
strength injection molded polymer materials. This goal was achieved and the aim of this
project is now to conduct a feasibility and effectiveness study and to assess the design of
the device. The investigators will be fitting up to 50 transtibial amputees that are current
prosthesis users with the iFIT device. Patients will wear the device for 1 month and evaluate
for comfort, stability and ease of use as compared to their conventional device.
Inclusion Criteria:
- transtibial level of amputation
- functional ambulator with or without a cane with a well-fitting standard prosthesis on
one or both limbs
- 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 250 lbs
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