NCT06996158

Prospective Evaluation Assessing U2 MB™ Total Knee System

Prospective Evaluation Assessing Performance, Survivorship and Patient Reported Outcome Measures of Mobile Bearing Total Knee System (U2 MB™ Knee).

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: MSK Doctors & Associates Ltd · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Non-interventional prospective follow-up study.

Conditions

• Osteoarthritis
• Musculoskeletal Abnormalities

Timeline

• Start date: 2025-05-26
• Primary completion: 2038-05-27
• Completion: 2038-11-30
• First posted: 2025-05-30
• Last updated: 2025-05-30