iFIT Prosthesis for Pediatric Limb Loss

Overseen By Jessica L Kenia, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Open skin lesions, excessive pain, neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new adjustable prosthetic system designed specifically for children who have lost a limb. The goal is to assess the comfort and usefulness of this immediate fit prosthesis, known as the iFIT Prosthesis, both in the lab and at home. Children aged 3 to 18 who had a limb amputated at least four months ago and have no open wounds or severe pain may qualify. The trial involves using the new prosthesis at home for two months to gather feedback on its comfort and usability. As an unphased trial, this study offers a unique opportunity for children to experience innovative prosthetic technology and contribute to its development.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the iFIT Prosthesis is safe for children?

Research has shown that the iFIT prosthesis is generally safe for users. Its adjustable design has allowed people with limb loss to move safely and comfortably, as past studies have indicated. For instance, one study found that the iFIT prosthesis enabled people to walk without major issues.

The prosthesis is easy to adjust and fit, enhancing comfort and usability. Although safety data for children is limited, positive results in other groups suggest that the iFIT prosthesis is well-tolerated. Like any medical device, minor discomfort or need for adjustments might occur, but no serious problems have been reported with the iFIT system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iFIT Prosthesis for pediatric limb loss because it offers a customizable and immediate-fit solution, which is different from traditional prosthetics that often require multiple fittings and adjustments. The iFIT system is designed to be adjustable, allowing children to continue using the same prosthetic as they grow, which reduces the need for frequent replacements. Additionally, this prosthesis aims to improve comfort and functionality, with features like internal socket pressure monitoring and gait analysis to optimize fit and performance. These innovations could significantly enhance the quality of life for children with limb loss by providing a more adaptable and user-friendly prosthetic option.

What evidence suggests that the iFIT Prosthesis is effective for pediatric limb loss?

Research has shown that the iFIT Prosthesis could benefit children who have lost a limb. In this trial, participants will test the adjustable design, which studies have found helps prevent skin problems and pain, common with traditional prosthetics. Feedback from users has shown that it is comfortable, stable, and fits well. The prosthesis can be adjusted immediately, allowing it to fit better as a child grows or becomes more active. Overall, these features aim to improve life for children using the prosthesis. ^{2 6 7 8 9}

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

I can feel sensations in my amputated limb area.

I have lost a limb due to injury, birth condition, poor blood flow, diabetes, or cancer.

It has been at least 4 months since my amputation.

Exclusion Criteria

I have open skin wounds.

Inability to follow instructions for trial

I experience severe pain in the part of my limb that was amputated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

4-8 weeks

Multiple visits (in-person)

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.

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the home trial. Outcome measures are repeated.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iFIT Prosthesis

Trial Overview The study is testing the iFIT prosthesis—an adjustable prosthetic designed for kids' growth. It includes lab tests to finalize the prototype and a two-month home trial assessing comfort and function through questionnaires, pressure measurements inside the socket, and walking analysis.

How Is the Trial Designed?

Group I: Phase II Experimental Treatment 1 Intervention

Phase II involves a two month home trial to determine the comfort and utility of an adjustable prosthetic system for children. Children will be fit at several different locations by their prosthetist with the adjustable socket. They will complete several questionnaires on their current device, as well as have internal socket pressures and a gait analysis completed. They will return one month later to complete the same outcome measures on their conventional device. They will also be given activity monitors to track their activity through the duration of the project.

Group II: Phase I Experimental Treatment 1 Intervention

Phase I involves developing a final design for an adjustable, immediate fit prosthesis. We will recruit 5-10 participants age 3-12 to complete in-lab testing and evaluation of several designs. This testing will lead to the final product design to be tested in Phase II.

iFIT Prosthesis is already approved in United States for the following indications:

Approved in United States as iFIT Prosthetics for:

• Pediatric limb loss
• Lower limb amputation
• Transtibial amputation
• Transfemoral amputation
• Congenital limb loss

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

Prosthetic fitting for child and adolescent amputees allows them to regain nearly normal functional abilities, significantly enhancing their quality of life.

The process includes comprehensive support from pre-operative consultations to long-term monitoring, ensuring that young patients receive continuous care throughout their prosthetic journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The fitting of prostheses for children with a lower limb amputation]. Chiesa, G., Arfaoui, M., Fontugne, MJ.[2022]

Surgical management and prosthetic options for children with amputations have significantly improved, highlighting the importance of clinicians being knowledgeable about the latest technologies to provide optimal care.

An interdisciplinary approach is essential for managing juvenile patients, as it allows for personalized prosthetic solutions that align with the child's specific needs and developmental changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prosthetic management of children with limb deficiencies. Krebs, DE., Edelstein, JE., Thornby, MA.[2022]

Early fitting of prosthetics for children with upper extremity congenital deformities can help them integrate the device into their daily lives and social interactions, potentially enhancing their future choices regarding prosthesis use.

The decision to fit a prosthesis should involve a multidisciplinary team and consider both aesthetic and functional aspects, ensuring that the process is not seen as a constraint by the child or parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prosthesis for upper extremity congenital deformities]. Corti, J.[2008]

The ISNY above-knee prosthetic socket significantly enhances comfort, function, and appearance for juvenile amputees, thanks to its flexible polyethylene design that adapts to limb growth.

In a review of 10 subjects, all participants who previously used rigid sockets with pelvic band suspension were able to effectively use total or partial suction for the ISNY sockets, indicating good compatibility and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Icelandic-Swedish-New York above-knee prosthetic sockets: pediatric experience. Fishman, S., Edelstein, JE., Krebs, DE.[2019]

Altering the ankle mechanism of prosthetics can significantly reduce the moments transferred at the socket interface for transtibial amputees by up to 50%, which may alleviate pain and prevent deep tissue damage.

The development of an active non-anthropomorphic ankle prosthesis can maintain high power levels during walking while minimizing harmful pressures, potentially improving comfort and reducing the risk of osteoarthritis in sound limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redefining prosthetic ankle mechanics: non-anthropomorphic ankle design. LaPrè, AK., Sup, F.[2013]

The adjustable transfemoral prosthetic socket significantly outperformed the standard ischial ramus containment socket in accommodating volume fluctuations, showing improvements in subjective and performance measures by 19% to 93% depending on the volume condition.

In cases of simulated volume gain, the standard socket failed to function properly, while the adjustable socket allowed the subject to complete the walking protocol, highlighting its superior adaptability and potential for better user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COMPARATIVE EFFECTIVENESS OF AN ADJUSTABLE TRANSFEMORAL PROSTHETIC INTERFACE ACCOMMODATING VOLUME FLUCTUATION: CASE STUDY. Kahle, JT., Klenow, TD., Highsmith, MJ.[2020]

In India, there are 5,436,000 individuals with locomotor disabilities due to lower limb amputations, primarily caused by trauma, highlighting the urgent need for effective rehabilitation strategies for this young and active population.

The article outlines best practices and modern technologies for treating amputees, emphasizing the importance of optimal amputation level selection, preamputation preparation, and comprehensive rehabilitation to achieve the best outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prosthetic Rehabilitation in the Lower Limb. O'Keeffe, B., Rout, S.[2020]

Adjustable-volume prosthetic sockets can significantly improve fit and comfort for amputees by allowing micro-adjustments throughout the day, which helps prevent skin breakdown and enhances overall activity levels.

These innovative sockets also streamline the fitting process for prosthetists, reducing the need for extensive modifications and potentially leading to better patient outcomes, but their market adoption is hindered by reimbursement challenges that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable-Volume Prosthetic Sockets: Market Overview and Value Propositions. Klenow, TD., Schulz, J.[2023]

Citations

1. withpower.com withpower.com/trial/phase-limb-deficiencies-8-2021-11d67

iFIT Prosthesis for Pediatric Limb Loss Participants wear the adjustable prosthesis at home for 2 months to evaluate comfort and usability. Outcome measures include questionnaires, pressure data, and ...

2. reporter.nih.gov reporter.nih.gov/search/uJl3ibFI-0-6Q3zkvNtx-A/project-details/10382682

Project Details - NIH RePORTER Pediatric limb loss, although less common than in adults is associated with frequent skin breakdown and pain in the child's limb due to ill-fitting prostheses ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307020/

Clinical outcomes measurement in pediatric lower limb ... This study aimed to identify clinical measures that have been used to evaluate function, health related quality of life (HRQoL), and/or satisfaction in ...

4. ifitprosthetics.com ifitprosthetics.com/research-publications.html

Research Publications Self-reported outcome measures for comfort, stability and fit were similar in a new group of 21 subjects with transtibial limb loss with the iFIT prosthesis ...

5. smartpatients.com smartpatients.com/trials/NCT05230004

Innovative Prosthetic Systems for Pediatric Limb Loss to ... Summary. 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.

6. ifitprosthetics.com ifitprosthetics.com/

iFIT Prosthetics - Home iFIT Prosthetics provides high quality, patient-centered, affordable prosthetics to alleviate disparities in access to healthcare and prosthetic services.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590109521000240

An Immediate Fit, Adjustable, Modular Prosthetic System ... The iFIT prosthesis can be fit in 1 session. •. iFIT prostheses are modular and easily transported in bulk. •. Only a few hand tools are necessary to fit ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9482040/

A Prospective Assessment of an Adjustable, Immediate Fit ... The adjustable, immediate fit, subischial prosthesis provided safe, comfortable, and functional ambulation for persons with transfemoral limb loss.

9. allardusa.com allardusa.com/Allard%20USA/Prosthetics/iFIT/PDF%20Files/iFIT%20FINAL%20PUBLISHED%20TRANSTIBIAL%20PROSTHESIS%20Study.pdf

A PROSPECTIVE ASSESSMENT OF AN ADJUSTABLE, ... The purpose of this single-group pre-post study was to assess the use, satisfaction, safety, and ambulatory func- tion of the iFIT prosthetic device in a group ...