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NCT Number: NCT06996158

Prospective Evaluation Assessing U2 MB™ Total Knee System

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Non-interventional prospective follow-up study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Time frame: 10 years

Secondary outcomes

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

Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Principal Investigator

CONTACT

[email protected]

0330 001 0048

Tanvi Research Associate

CONTACT

[email protected]

0330 001 0048

Sponsors and collaborators

Lead sponsor

MSK Doctors & Associates Ltd

Industry

Collaborators

United Orthopedics Inc.

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2038
Study completion: 2038
First posted: May 30, 2025
Registry last updated: May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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