N/A
N=71
Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
Amputation
Bottom Line
View on ClinicalTrials.gov: NCT02886936 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Prosthetic Comfort and Utility Questionnaire (Version 1) — 25.52; 29.33 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iFIT Transtibial Prosthesis (Device); iFIT Transfemoral Prosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prosthetic Comfort and Utility Questionnaire (Version 1) |
25.52; 29.33 | — |
| PRIMARY Prosthetic Comfort and Utility Questionnaire (Version 2) |
29; 25.4 | — |
| PRIMARY Prosthetic Comfort and Utility Evaluation (Version 3) |
40.9; 32.8 | — |
| SECONDARY Number of Participants With Device Related Adverse Events |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Gait Analysis- Walking Speed |
.98; .98; .98; .98 | — |
| SECONDARY Internal Socket Pressure |
17.3; 19.3; 18; 22; 15.5; 16.3 | — |
| SECONDARY Gait Analysis - Double Support |
.37; .36; .37; .35 | — |
| SECONDARY Gait Analysis - Limp Index |
.99; .97; 1.01; 1.03 | — |
| SECONDARY Gait Analysis - Stride Length |
1.22; 1.22; 1.22; 1.21 | — |
| SECONDARY Gait Analysis Stance Phase |
64.3; 63.4; 65.2; 65 | — |
| SECONDARY Residual Limb Circumference Measurements to Internal Socket Diameter |
51.7; 47.2; 40.6; 53.6; 47.7; 41.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02886936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.