Prospective Evaluation Assessing U2 MB™ Total Knee System

Launched by MSK DOCTORS & ASSOCIATES LTD · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the United Orthopaedics Mobile Bearing Total Knee System (U2 MB™ Knee) to see how safe and effective it is for patients who need total knee replacement surgery due to severe knee arthritis. The main goal is to find out how long the knee implants last and how well they work for patients over a period of 10 years. Participants will need to come back for check-ups at 1, 3, 5, and 10 years after their surgery, during which they will have tests to evaluate their knee function and take images to assess the implant.

To be eligible for this trial, patients should be planning to have a knee replacement and be suitable for a specific type of implant. They should be at least 21 years old and able to understand and sign the consent form, meaning they can agree to participate in the study. However, patients with certain conditions, like active infections in the knee or those who can't follow the study's guidelines, won't be able to join. Overall, the trial aims to gather important information about how the U2 MB™ Knee performs and how it affects patients' quality of life over the long term.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. All patients suitable for a cemented Total Knee Replacement, MBC design
• • 2. All elective pathology (including Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis not requiring stemmed components, Avascular necrosis)
• • 3. Willing to voluntarily sign the informed consent form
• • 4. 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 Criteria:
• • 1. Skeletally immature (less than 21 years of age) at time of implantation
• • 2. Active native knee joint infection
• • 3. Post-traumatic arthritis requiring stemmed components
• • 4. Malignancy around the knee
• • 5. All patients who are personally unable to take part in fully informed consent (dementia, reduced AMTS etc)
• • 6. Patients who will not be available to return for the predetermined appointments in order to complete the 10 years follow-up
• • 7. 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
• • 8. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol