Clinical trial NCT06996158: Prospective Evaluation Assessing U2 MB™ Total Knee System
Official title: Prospective Evaluation Assessing Performance, Survivorship and Patient Reported Outcome Measures of Mobile Bearing Total Knee System (U2 MB™ Knee).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis
Musculoskeletal Abnormalities
Lead sponsor: MSK Doctors & Associates Ltd
Sponsor class: INDUSTRY
Collaborators: name: United Orthopedics Inc.
First posted: 2025-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic

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 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.

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

Primary outcomes:
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.
timeFrame: 10 years
Secondary outcomes:
measure: Two standardized scores will grade the functional score of the knee joint over time: Knee Society Score (KSS) and Oxford Knee Score (OKS)
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
citation: Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.