Prospective Evaluation Assessing U2 MB™ Total Knee System

Prospective Evaluation Assessing Performance, Survivorship and Patient Reported Outcome Measures of Mobile Bearing Total Knee System (U2 MB™ Knee).

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06996158

Enrollment

150

Registered

2025-05-30

Start date

2025-05-26

Completion date

2038-11-30

Last updated

2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Abnormalities, Osteoarthritis

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	10 years

Secondary

Measure	Time frame
Two standardized scores will grade the functional score of the knee joint over time: Knee Society Score (KSS) and Oxford Knee Score (OKS)	10 years

Contacts

Primary ContactPaul Principal Investigator

paul.lee@mskdoctors.com0330 001 0048

Backup ContactTanvi Research Associate

tanvi@mskdoctors.com0330 001 0048

Outcome results