RecruitingNCT05787821

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation


Sponsor

Zimmer Biomet

Enrollment

760 participants

Start Date

Jun 28, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a specific knee implant component — the Persona OsseoTi Keel — used in total knee replacement surgery. Researchers want to confirm that this implant works safely and effectively across a wide range of patients, including those having their first or revision knee replacement. **You may be eligible if...** - You are an adult of legal age with fully developed bones - Your doctor has determined you need a total knee replacement (or revision of a prior knee replacement) - You are willing to attend follow-up appointments as required by the study - You are able to provide written consent **You may NOT be eligible if...** - You are currently participating in another surgical or pain management study - You are pregnant - You have a mental or neurological condition that prevents you from following post-operative instructions - You are institutionalized, have significant drug or alcohol dependence, or cannot understand study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETotal Knee Arthroplasty

Total knee replacement.


Locations(16)

Denver Hip & Knee, Inc.

Parker, Colorado, United States

Foundation for Orthopaedic Research & Education

Tampa, Florida, United States

Northside Hospital, Inc.

Atlanta, Georgia, United States

U of L Health

Louisville, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, United States

New Mexico Orthopaedic Associates

Albuquerque, New Mexico, United States

Syracuse Orthopaedic Specialists

DeWitt, New York, United States

NYU

New York, New York, United States

St. Francis Hospital & Heart Center

Roslyn, New York, United States

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, United States

Duke University

Morrisville, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

UT Health at Houston

Houston, Texas, United States

UVA Health Orthopedic Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05787821


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