Actively Recruiting

Age: 18Years +
All Genders
NCT05787821

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Led by Zimmer Biomet · Updated on 2026-01-20

760

Participants Needed

16

Research Sites

622 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years or older and skeletally mature
  • Patient is willing and able to provide written informed consent
  • Patient is willing and able to complete all scheduled follow-up evaluations
  • Patient qualifies for cemented or cementless primary or revision total knee arthroplasty with the Persona Knee System and compatible Zimmer Biomet components according to product labeling
Not Eligible

You will not qualify if you...

  • Currently participating in another surgical intervention or pain management study
  • Pregnant or a member of a protected vulnerable population (e.g., prisoner, mentally incompetent)
  • Has a mental or neurological condition preventing post-operative care compliance
  • Has any condition placing the patient at undue risk or interfering with the study
  • Institutionalized, known drug abuser, alcoholic, or unable to understand study requirements
  • Scheduled for simultaneous bilateral total knee arthroplasty
  • Previous infection in the affected joint or other local/systemic infections
  • Insufficient bone stock on femoral or tibial surfaces
  • Neuropathic arthropathy
  • Osteoporosis or neuromuscular disease compromising the affected limb
  • Stable, painless arthrodesis in a functional position
  • Severe instability due to absence of collateral ligament integrity
  • Rheumatoid arthritis with skin ulcer or recurrent skin breakdown
  • Valgus deformity over 5° with medial collateral ligament insufficiency and planned personalized alignment surgical technique

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Denver Hip & Knee, Inc.

Parker, Colorado, United States, 80138

Actively Recruiting

2

Foundation for Orthopaedic Research & Education

Tampa, Florida, United States, 33607

Actively Recruiting

3

Northside Hospital, Inc.

Atlanta, Georgia, United States, 30342

Active, Not Recruiting

4

U of L Health

Louisville, Kentucky, United States, 40202

Actively Recruiting

5

University of Michigan

Ann Arbor, Michigan, United States, 48109

Active, Not Recruiting

6

Mayo Clinic

Rochester, Minnesota, United States, 55902

Actively Recruiting

7

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, United States, 39202

Active, Not Recruiting

8

New Mexico Orthopaedic Associates

Albuquerque, New Mexico, United States, 87110

Actively Recruiting

9

Syracuse Orthopaedic Specialists

DeWitt, New York, United States, 13214

Actively Recruiting

10

NYU

New York, New York, United States, 11016

Actively Recruiting

11

St. Francis Hospital & Heart Center

Roslyn, New York, United States, 11576

Actively Recruiting

12

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, United States, 28207

Actively Recruiting

13

Duke University

Morrisville, North Carolina, United States, 27560

Actively Recruiting

14

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

15

UT Health at Houston

Houston, Texas, United States, 77030

Actively Recruiting

16

UVA Health Orthopedic Center

Charlottesville, Virginia, United States, 22903

Active, Not Recruiting

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Research Team

E

Erik Kowalski, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

12

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