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Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot

NCT04239222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-09-23

Study results available
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Summary

A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.

Conditions

  • Lower Limb Amputation Below Knee (Injury)
  • Lower Limb Amputation Above Knee (Injury)
  • Lower Limb Amputation Knee

Interventions

DEVICE

Revo-M

Investigational energy storage and return prosthetic foot with using novel elastic elements.

DEVICE

Taleo

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects

DEVICE

Proflex XC

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects

Sponsors & Collaborators

  • Otto Bock Healthcare Products GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2022-03-11
Completion
2022-03-11

Countries

  • United States

Study Locations

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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 NCT04239222 on ClinicalTrials.gov