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Clinical Investigation (Beta) of a New Developed Prosthetic Knee

NCT06748729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-09-04

Study results available
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Summary

The aim of this investigation is to evaluate the efficacy of the investigational device regarding performance improvements and satisfaction in descending activities for moderate to high active prosthesis users within the intended population for the investigational device. Additionally, the overall satisfaction for activities of daily living will be evaluated after a certain time of use (4 weeks home use).

Conditions

  • Amputation

Interventions

DEVICE

Navii Knee

Microprocessor controlled prosthetic knee (MPK)

Sponsors & Collaborators

  • Össur Iceland ehf

    lead INDUSTRY

Principal Investigators

  • Kurt N. Gruben · Össur Americas

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2024-03-28
Completion
2024-03-28
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 NCT06748729 on ClinicalTrials.gov