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NCT02886936 · ClinicalTrials.gov registry record · NA
Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 71
- Enrollment target
NCT02886936: Completed NA study, sponsored by University of Pennsylvania.
NCT02886936 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 71 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02886936, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
Study 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.
Primary Outcome
This questionnaire is based off of the Prosthetic Evaluation Questionnaire; it involves questions taken from the original that focus on comfort, satisfaction and utility of a prosthetic socket. We used numeric values from 1 (Poor) through 5 (Excellent) for evaluation. This version featured seven questions for a total of 35 points possible and the lowest score being 7 (higher scores are better). Scores are reported as total with standard deviations.
Interventions
- DEVICE iFIT Transtibial Prosthesis
- DEVICE iFIT Transfemoral Prosthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2022-05-31 |
| Phase | NA |
What the finished NCT02886936 record still lists
NCT02886936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which iFIT Transtibial Prosthesis is the first listed.
NCT02886936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02886936 about?
NCT02886936 is a clinical study titled "Immediate Fit Using Innovative Technology Transtibial & Transfemoral Prosthesis". 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 ...
What is the current status of trial NCT02886936?
This trial is currently completed. It is a NA study. The enrollment target is 71 participants. The study started on 2018-05-01. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT02886936?
The interventions under investigation include: iFIT Transtibial Prosthesis (DEVICE), iFIT Transfemoral Prosthesis (DEVICE).
Who is sponsoring clinical trial NCT02886936?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02886936's enrollment target sits among peer trials
71 1102nd of 2000 higher than 898 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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