An Investigation on Function and Performance of a New Microprocessor Controlled Prosthetic Knee

Completed · Not applicable

Conditions studied: Prosthesis User, Amputation

In brief

This investigation aims to compare the functional performance of a new passive microprocessor-controlled Prosthetic Knee to subjects usual microprocessor-controlled prosthetic knee.

Key facts

Study ID

NCT05523349

Run by

Össur Iceland ehf

People needed

14

Starts

2022-08-15

Expected to finish

2022-09-30

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Age ≥ 18 years
• Willing and able to participate in the study and follow the protocol
• Moderate to high active users (PLUS M T-score>4021)

You may not qualify if…

• 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 Rheo Knee 4 setup, as described in Instructions for use.
• Osseointegration

Where it is running

• Bionic P & O — Merrillville, Indiana, United States
• Oakland Orthopedic appliances — Bay City, Michigan, United States
• Perry Prosthetics — Perrysburg, Ohio, United States
• Ossur Motionlab — Reykjavik, Iceland

Full record on ClinicalTrials.gov

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