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Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth

NCT05230004 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-13

No results posted yet for this study

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. 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.

Conditions

  • Limb Deficiencies
  • Pediatric ALL

Interventions

DEVICE

iFIT prosthesis

An adjustable modular prosthesis that can be fit in a single session. Fully adjustable by wearer.

Sponsors & Collaborators

Principal Investigators

  • Timothy R Dillingham, MS,MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-18
Primary Completion
2025-03-07
Completion
2027-01-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230004 on ClinicalTrials.gov