Clinical Trial

Prospective Evaluation Assessing U2 MB™ Total Knee System

Not Yet Recruiting
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Summary
The goal of this study is to evaluate the safety and effectiveness of the United Orthopaedics Mobile Bearing Total Knee System (U2 MB™ Knee) in patients undergoing total knee replacement surgery due to end-stage knee osteoarthritis. The main questions it aims to answer are: 1\. What is the component survivorship of the U2 MB™ Knee system at 1, 3, 5, and 10 years? Participants will: 1. Return for follow-up assessments at Year 1, Year 3, Year 5, and Year 10 after surgery 2. Undergo clinical evaluations including functional outcome scoring, radiographic imaging. This study will take place across three investigational sites and will involve 150 knee replacements using U2 MB™ components. The study's objectives include assessing early to long-term outcomes in terms of implant survivorship, clinical function, patient satisfaction, radiological findings, and overall safety of the device over a 10-year period.
Trial Details
NCT Number NCT06996158
Lead Sponsor MSK Doctors & Associates Ltd
Collaborators: United Orthopedics Inc.
Conditions Osteoarthritis, Musculoskeletal Abnormalities
Enrollment 150 participants
Start Date 2025-05-26
Primary Completion 2038-05-27 (estimated)
Study Completion 2038-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-30