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Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic

NCT04787627 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-09-22

Study results available
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Summary

Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK).

The primary objective was to evaluate the efficacy of the investigational device in reducing exertion during walking compared to passive MPKs. Additionally to evaluate the efficacy of the investigational device in the short and long term compared to passive MPKs and previous versions of the Power Knee, during daily living activities i.e. walking on level ground, in stairs and inclines, rising from and sitting down to a chair as well as performance of gait functions and ease of set up for average to highly active transfemoral/knee disarticulation amputees and Certified Prosthetists/Orthotists (CPOs).

Conditions

  • Prosthesis User
  • Amputation

Interventions

DEVICE

Power Knee

Powered microprocessor controlled prosthetic knee

Sponsors & Collaborators

  • Medical Center Orthotics and Prosthetics

    collaborator UNKNOWN

  • Össur Iceland ehf

    lead INDUSTRY

Principal Investigators

  • Ian Fothergill, CPO · Medical Center Orthotics and Prosthetics (MCOP) Silver Spring

  • John Warren, CPO · Medical Center Orthotics and Prosthetics (MCOP) Boston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2020-07-06
Completion
2020-07-06
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 NCT04787627 on ClinicalTrials.gov