Clinical Investigation (Beta) of a New Developed Prosthetic Knee

NCT ID: NCT06748729

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2024-03-28

Brief 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).

Detailed Description

This investigation is a non-randomized single group repeated measures open label prospective design with observational and self-report measures.

Two scheduled study events are planned for amputee subjects, with 4 weeks between visits.

Conditions

Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Exploratory testing of a new prosthetic knee

The investigational device is provided to subjects, who then use it as their main prosthesis for a period of 4 weeks prior to returning for data collection on the device.

Group Type: EXPERIMENTAL

Navii Knee

Intervention Type: DEVICE

Microprocessor controlled prosthetic knee (MPK)

Interventions

Navii Knee

Microprocessor controlled prosthetic knee (MPK)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 45Kg< body weight < 136Kg
• Cognitive ability to understand all instructions and questionnaires in the study;
• Unilateral TF/KD amputees that are regular prosthesis users for at least 3 months
• Current MPK users (passive MPKs only) regularly performing descent activities (stairs/ramps)
• Age ≥ 18 years
• Willing and able to participate in the study and follow the protocol

Exclusion Criteria

• Users with stump pain
• Users with socket problems
• Pregnant Users
• Users using Power Knee, Kenevo or mechanical knees as their prescribed prosthesis
• Alignment that cannot be matched with the Navii setup, as described in Instructions for use.
• Osseointegration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Össur Iceland ehf

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt N. Gruben

Role: PRINCIPAL_INVESTIGATOR

Össur Americas

Locations

Össur Orlando

Orlando, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CIP2023120529

Identifier Type: -

Identifier Source: org_study_id