Actively Recruiting
Persona OsseoTi Keel Compatibility Study A Multicenter Cohort Study to Demonstrate Safety, Performance, and Clinical Benefits of the Persona Knee System and Instrumentation
Led by Zimmer Biomet · Updated on 2026-01-20
760
Participants Needed
16
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, performance, and clinical benefits of the Persona knee implant and its instruments in people undergoing primary or revision total knee arthroplasty. This prospective, multicenter study collects data on patients receiving the Persona Total Knee System, which has been cleared by regulatory authorities. The study involves patients with various knee conditions including osteoarthritis, rheumatoid arthritis, and deformities. Participants will undergo total knee replacement using different implant configurations, including cemented or cementless femur and tibia components. The study captures data from multiple cohorts reflecting various implant combinations. The design includes preoperative clinical evaluations and systematic follow-up visits at 3 months, 1, 2, 5, 7, and 10 years after surgery to monitor outcomes. During the study, patients will have clinical assessments to record patient-reported outcomes such as the Oxford Knee Score and quality of life measures like the EQ-5D-5L. Pain and satisfaction levels will also be tracked. Researchers will observe implant performance and safety over a five-year period, with extended follow-up up to 10 years. Participants are expected to attend scheduled evaluations to provide data for these measures.
CONDITIONS
Brief Title
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is legally an adult and has mature bones
- Patient can provide written informed consent by signing the approved consent form
- Patient agrees to complete all scheduled follow-up visits as outlined in the study
- Patient qualifies for cemented or cementless primary or revision total knee arthroplasty using the Persona Knee System as labeled
You will not qualify if you...
- Patient is currently participating in another surgical or pain management study
- Patient is pregnant or part of a protected vulnerable group (e.g., prisoner, mentally incompetent)
- Patient has mental or neurological conditions that prevent following postoperative care
- Patient has conditions that increase risk or interfere with study conduct as judged by the investigator
- Patient is institutionalized, a known drug abuser or alcoholic, or cannot understand study requirements
- Patient is scheduled for simultaneous bilateral total knee arthroplasty
- Patient has a history of infection in the affected joint or other infections affecting the prosthesis
- Patient has insufficient bone stock on femoral or tibial surfaces
- Patient has neuropathic arthropathy
- Patient has osteoporosis, muscle loss, or neuromuscular disease affecting the limb
- Patient has a stable, painless arthrodesis with good function
- Patient has severe instability due to missing collateral ligament integrity
- Patient has rheumatoid arthritis with skin ulcers or recurrent skin breakdown
- Patient has more than 5° valgus deformity with medial collateral ligament insufficiency and plans personalized alignment surgery technique
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo total knee arthroplasty using the Persona Knee System.
1 visit (in-person)
Duration - Up to 10 years post-operatively
Participants attend clinical follow-up visits to collect data on safety, performance, and clinical outcomes after their knee replacement surgery.
Follow-up visits at 3 months, 1 year, 2 years, 5 years, 7 years, and 10 years (in-person)
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
Research Team
E
Erik Kowalski, PhD
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here