







































 

 

Dillingham T.R, Kenia J, Shofer F.S, Marschalek J. AN IMMEDIATE FIT AND ADJUSTABLE TRANSTIBIAL PROSTHETIC SYSTEM; A PROSPECTIVE FEASIBILITY AND EFFICACY STUDY. 
CANADIAN PROSTHETICS & ORTHOTICS JOURNAL, VOLUME 1, ISSUE 2, 2018; ABSTRACT, POSTER PRESENTATION AT THE AOPA’S 101ST NATIONAL ASSEMBLY, SEPT. 26-29, 
VANCOUVER, CANADA, 2018.DOI: https://doi.org/10.33137/cpoj.v1i2.32025                                                                           

 

1 

 
OPEN  ACCESS 

 

AOPA’S 101 ST NATIONAL ASSEMBLY ABSTRACTS, SEPTEMBER 26-29, VANCOUVER, CANADA, 2018 
 

ABSTRACT (POSTER PRESENTATION) 

AN IMMEDIATE FIT AND ADJUSTABLE TRANSTIBIAL PROSTHETIC SYSTEM; A 

PROSPECTIVE FEASIBILITY AND EFFICACY STUDY 

Timothy R. Dillingham1, Jessica Kenia1*, Frances S. Shofer2, Jim Marschalek3 

 
1Department of Physical Medicine and Rehabilitation, University of Pennsylvania School of Medicine; Philadelphia, PA, USA. 
2Department of Emergency Medicine, University of Pennsylvania School of Medicine; Philadelphia, PA, USA. 
3Advanced Design Concepts, Pewaukee, WI, USA. 

* Email: Jessica.Kenia@uphs.upenn.edu 

DOI: https://doi.org/10.33137/cpoj.v1i2.32025  

 

INTRODUCTION 

Limb loss rates globally are rising and there is a large 

unmet need for an affordable and accessible prosthetic 

system for this growing US and International population.  

The purpose of this prospective cohort study was to 

assess the feasibility and utility of a novel immediate fit 

modular prosthetic system (IFIT Prosthetics, LLC™ 

prosthesis) for transtibial amputees. 

METHODS 

Transtibial amputees at least 6 months post amputation 

currently using a conventional prosthesis were enrolled 

after full consent under an IRB approved protocol. They 

were excluded if they had skin wounds, excessive limb 

or phantom pain, and a neurological disorder that 

interfered with gait. The PI fit and aligned all devices. 

The participants were instructed to wear the prosthesis 

for a two-week evaluation period in order to compare it 

to their own device.  A questionnaire based off the 

Prosthetic Evaluation Questionnaire (PEQ) was given on 

their current device during their first visit and they 

evaluated the IFIT prosthesis during the follow up visit.  

A gait biomechanical analysis and pressure evaluations 

(Fujifilm Prescale®) were conducted.  All adverse events 

or mechanical issues were recorded.   

RESULTS 

Twenty-six participants agreed to participate in the trial.  

Twenty-two amputees completed the study, with four not 

willing to travel for follow up.    Mean age for subjects 

completing the study was 51.1, SD ±11.3 years, with 3 

females and 19 males enrolled. Fourteen were 

dysvascular amputees and eight had traumatic etiologies. 

A significant difference in self-reported satisfaction was 

found for the IFIT device 29.33, SD ± 4.51 versus mean 

score for own device = 25.52, SD ± 6.8 (p= 0.0323) 

(Table 1).  No falls or limb ischemia were reported.  Two 

people had minor skin breakdown that resolved with 

realigning and altering socket liner. Gait biomechanics 

revealed no differences in any temporal values.  

Pressures were significantly lower in the iFIT prosthesis 

versus a conventional prosthesis p = .0014 and at anterior 

tibia p=.0002, and lateral side p=.013 (Figure 1). 

 

 

DISCUSSION 

The IFIT prosthesis compared favorably to subjects’ 

conventional prostheses in terms of self-reported 

satisfaction and gait.   Intra-Socket pressures were lower 

than in conventional devices.  The IFIT device 

demonstrated safety and efficacy in this prospective trial.   

mailto:Jessica.Kenia@uphs.upenn.edu
https://doi.org/10.33137/cpoj.v1i2.32025


 

 

Dillingham T.R, Kenia J, Shofer F.S, Marschalek J. AN IMMEDIATE FIT AND ADJUSTABLE TRANSTIBIAL PROSTHETIC SYSTEM; A PROSPECTIVE FEASIBILITY AND EFFICACY STUDY. 
CANADIAN PROSTHETICS & ORTHOTICS JOURNAL, VOLUME 1, ISSUE 2, 2018; ABSTRACT, POSTER PRESENTATION AT THE AOPA’S 101ST NATIONAL ASSEMBLY, SEPT. 26-29, 
VANCOUVER, CANADA, 2018.DOI: https://doi.org/10.33137/cpoj.v1i2.32025                                                                           

 

2 

 
OPEN  ACCESS 

 

AOPA’S 101 ST NATIONAL ASSEMBLY ABSTRACTS, SEPTEMBER 26-29, VANCOUVER, CANADA, 2018 
 

ABSTRACT (POSTER PRESENTATION) 

With its potential cost and accessibility advantages, the 

IFIT prosthetic system holds promise to enhance access 

for transtibial amputees. 

 

 
Figure 1. Average Peak Pressure: iFIT versus Conventional 

Prosthesis. An estimated pressure in pounds/square inch (psi) 

is indicated next to the mean values and reflects an estimated 

pressure as determined through nomographic scoring  

(Fujifilm ). These are peak pressures that occurred with 

ambulation. 

 

CONCLUSION 

The iFIT transtibial prosthetic system is safe and 

effective in this short term trial. A larger multicenter 

comparative effectiveness study is needed to confirm 

these findings. 

ACKNOWLEDGMENT 

This study was funded by the National Institutes of Health, 

National Institute on Aging (Grants: 2SB1AG050430-06 and 

2R42AG050430-04) and the NICHD and NCMRR (Grants 

2R42 HD 069067-02 and 1R41HD069067 – 01). Dr. 

Dillingham founded the company IFIT Prosthetics, LLC® and 

is the major owner and director. Patient testing occurred at the 

University of Pennsylvania under sub-contact and included a 

Provost conflict of interest management plan for the PI. 

DISCLAIMER AND CONFLICT OF INTEREST 

STATEMENT 

The PI founded the company IFIT Prosthetics, LLC and is the 

major owner and director.  He has financial interest in the 

prosthetic system being presented in this article.  He signed 

NIH compliant conflict of interest management agreements 

with the University where research was conducted. 

 

 


