Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"

Status unconfirmed

Conditions studied: Osteo Arthritis Knee

In brief

The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.

Key facts

Study ID

NCT03060057

Run by

United Orthopedic Corporation

People needed

200

Starts

2017-03-30

Expected to finish

2026-03-30

Last updated by the study team

2023-06-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is between 18 and 75 years of age
• Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device
• Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee
• Subject is willing and able to provide informed consent to participate in the study;
• Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;

You may not qualify if…

• Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.

Where it is running

• Coastal Orthopedics — Bradenton, Florida, United States
• Jacksonville Orthopaedic Institute — Jacksonville, Florida, United States
• Orthopedic Center of Vero Beach — Vero Beach, Florida, United States
• Rubin Institute for Advanced Orthopedics — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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