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Prospective Evaluation Assessing U2 MB™ Total Knee System

NCT06996158 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • United Orthopedics Inc.

    collaborator UNKNOWN

  • MSK Doctors & Associates Ltd

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-26
Primary Completion
2038-05-27
Completion
2038-11-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06996158 on ClinicalTrials.gov