iFIT Prosthesis for Pediatric Limb Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
An immediate fit adjustable prosthetic system is being investigated for children. The age range being recruited is from 3 years up to 18 years old. Phase I of this study will involve developing a final prototype by conducting in-lab testing on children with limb loss. Phase II will involve a two month home trial to further evaluate the comfort and usability of the socket. Outcome measures include a PEQ-based questionnaire, socket pressure measures and gait analysis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
How does the iFIT Prosthesis treatment differ from other treatments for pediatric limb loss?
The iFIT Prosthesis is unique because it offers a mechanical volume management system that can be adjusted to accommodate a child's growth, providing a more personalized and comfortable fit compared to traditional prosthetic options. This flexibility is particularly beneficial for children, as it allows the prosthesis to adapt as they grow, potentially reducing the need for frequent replacements.12345
What data supports the effectiveness of the iFIT Prosthesis treatment for pediatric limb loss?
The adjustable-volume prosthetic sockets, like those used in the iFIT Prosthesis, have shown to improve fit and comfort by accommodating volume fluctuations, which can enhance function and mobility for users. A case study demonstrated that adjustable sockets improved subjective and performance measures by 16% to 50% compared to standard sockets, indicating potential benefits for children with limb loss.13678
Who Is on the Research Team?
Timothy R Dillingham, MS,MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for children aged 3-18 who have lost a limb due to trauma, birth defects, poor blood flow/diabetes, or cancer. They must be at least four months post-amputation with no open skin wounds, able to follow instructions and without severe pain or neurological issues affecting their other leg.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I: In-lab Testing
Participants undergo in-lab testing to evaluate and refine the prosthetic design. Feedback is collected to influence the final design.
Phase II: Home Trial
Participants wear the adjustable prosthesis at home for 2 months to evaluate comfort and usability. Outcome measures include questionnaires, pressure data, and gait analysis.
Follow-up
Participants are monitored for safety and effectiveness after the home trial. Outcome measures are repeated.
What Are the Treatments Tested in This Trial?
Interventions
- iFIT Prosthesis
iFIT Prosthesis is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Children's Hospital of Philadelphia
Collaborator