Prospective Evaluation assessing U2 MB™ Total Knee System
Research type
Research Study
Full title
Prospective Evaluation assessing Performance, Survivorship and Patient Reported Outcome Measures of Mobile Bearing Total Knee System (U2 MB™ Knee).
IRAS ID
345483
Contact name
Paul Lee
Contact email
Sponsor organisation
United Orthopedics
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Joint replacement surgery is the definitive treatment option for end stage knee osteoarthritis. The study is conducted to evaluate the safety and effectiveness of United Orthopedics Mobile Bearing Total Knee System (U2 MB™ Knee). The study will be conducted in 3 investigational sites, newly or previously implanted subjects will be prospectively followed up. The U2 MB™ Knee system consists of three components and each of these components will be assessed for component survivorship at 1,3,5 and 10 years. A total of 150 total knee replacements with U2 MB™ components will be performed. Subjects will have to visit during screening, Year 1, Year 3, Year 5 and Year 10, hence a total of 5 visits depending on the time of enrollment. The objectives of this study are to estimate the component survivorship, functional outcome scores, subject satisfaction at early, midterm, and long-term follow-up, radiography images and safety and tolerability of the system. The total study duration will be 10 years.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
25/WM/0048
Date of REC Opinion
12 May 2025
REC opinion
Further Information Favourable Opinion