Status:
NOT_YET_RECRUITING
Prospective Evaluation Assessing U2 MB™ Total Knee System
Lead Sponsor:
MSK Doctors & Associates Ltd
Collaborating Sponsors:
United Orthopedics Inc.
Conditions:
Osteoarthritis
Musculoskeletal Abnormalities
Eligibility:
All Genders
21+ years
Brief 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 t...
Detailed Description
Non-interventional prospective follow-up study.
Eligibility Criteria
Inclusion
- All patients suitable for a cemented Total Knee Replacement, MBC design
- All elective pathology (including Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis not requiring stemmed components, Avascular necrosis)
- Willing to voluntarily sign the informed consent form
- Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.
Exclusion
- Skeletally immature (less than 21 years of age) at time of implantation
- Active native knee joint infection
- Post-traumatic arthritis requiring stemmed components
- Malignancy around the knee
- All patients who are personally unable to take part in fully informed consent (dementia, reduced AMTS etc)
- Patients who will not be available to return for the predetermined appointments in order to complete the 10 years follow-up
- Has inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
- Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
Key Trial Info
Start Date :
May 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2038
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06996158
Start Date
May 26 2025
End Date
November 30 2038
Last Update
May 30 2025
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