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Not yet recruiting NCT06996158

Prospective Evaluation Assessing U2 MB™ Total Knee System

— Observational Osteoarthritis Musculoskeletal Abnormalities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Osteoarthritis, Musculoskeletal Abnormalities. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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 outcome measures (1)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT06996158 · 25/WM/0048

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗