Prospective Evaluation Assessing U2 MB™ Total Knee System

NCT ID: NCT06996158

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2038-11-30

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.

Conditions

Osteoarthritis; Musculoskeletal Abnormalities

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Knee implant group

No interventions assigned to this group

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United Orthopedics Inc.

UNKNOWN

Sponsor Role: collaborator

MSK Doctors & Associates Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Paul Principal Investigator

Role: CONTACT

paul.lee@mskdoctors.com

0330 001 0048

Tanvi Research Associate

Role: CONTACT

tanvi@mskdoctors.com

0330 001 0048

References

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.

Reference Type: BACKGROUND

PMID: 17403800 (View on PubMed)

Other Identifiers

25/WM/0048

Identifier Type: -

Identifier Source: org_study_id