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EmPOWERing Active Seniors With Energy

NCT02958553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-04-24

Study results available
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Summary

A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.

Conditions

  • Amputation

Interventions

DEVICE

emPOWER Ankle

The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.

DEVICE

Subject's own passive prosthesis

Devices will vary. Data gathered will form a baseline.

Sponsors & Collaborators

  • BionX Medical Technologies, Inc.

    collaborator INDUSTRY

  • Otto Bock Healthcare Products GmbH

    lead INDUSTRY

Principal Investigators

  • Danielle Melton, M.D. · Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2018-07-31
Completion
2018-07-31
FDA Device
Yes

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 NCT02958553 on ClinicalTrials.gov