Prospective Evaluation Assessing U2 MB™ Total Knee System

Sponsor
MSK Doctors & Associates Ltd
Study ID
NCT06996158
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 30, 2025
Start date
May 26, 2025
Status verified
May 2025
Primary completion
May 27, 2038
Completion
Nov 30, 2038

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Knee implant group

Primary Outcome Measure

Study of the survivorship of the U2 MB™ Knee system and its components, defined as no removal or revision of any components during a 10-year interval after implantation. [ Time Frame: 10 years ]

Central Contacts

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