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

40 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

Research Team

Timothy R Dillingham, MS,MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prosthetic management of children with limb deficiencies. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Adjustable-Volume Prosthetic Sockets: Market Overview and Value Propositions. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

COMPARATIVE EFFECTIVENESS OF AN ADJUSTABLE TRANSFEMORAL PROSTHETIC INTERFACE ACCOMMODATING VOLUME FLUCTUATION: CASE STUDY. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Prosthetic Rehabilitation in the Lower Limb. [2020]

5. France pubmed.ncbi.nlm.nih.gov

[Prosthesis for upper extremity congenital deformities]. [2008]

6. France pubmed.ncbi.nlm.nih.gov

[The fitting of prostheses for children with a lower limb amputation]. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Icelandic-Swedish-New York above-knee prosthetic sockets: pediatric experience. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Redefining prosthetic ankle mechanics: non-anthropomorphic ankle design. [2013]