Prospective Evaluation Assessing U2 MB™ Total Knee System

NCT06996158 | Not Yet Recruiting

• 1 other identifier: 25/WM/0048
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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. 1.Return for follow-up assessments at Year 1, Year 3, Year 5, and Year 10 after surgery
2. 2.Undergo clinical evaluations including functional outcome scoring, radiographic imaging.

Conditions

Osteoarthritis; Musculoskeletal Abnormalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Knee implant group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MSK Doctors & Associates Ltd: lead
• United Orthopedics Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 17403800 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Musculoskeletal Abnormalities

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Paul Principal Investigator

CONTACT

0330 001 0048; paul.lee@mskdoctors.com

Tanvi Research Associate

CONTACT

0330 001 0048; tanvi@mskdoctors.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): May 27, 2038
• Study Completion (Estimated): November 30, 2038
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share