Actively Recruiting
Persona Revision Knee System Outcomes
Led by Zimmer Biomet · Updated on 2025-10-24
380
Participants Needed
16
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.
CONDITIONS
Official Title
Persona Revision Knee System Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female of at least 18 years of age at the time of screening.
- Signed an institutional review board approved informed consent.
- Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions.
- Previous medical diagnosis or history of at least one of the following conditions treated with the Persona Revision Knee System according to instructions for use: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, post-traumatic joint configuration loss with patellofemoral erosion or dysfunction, prior patellectomy, moderate valgus, varus, or flexion deformities, salvage of failed surgical attempts, or knee instability in flexion at surgery.
- A pre-operative Knee Society Knee Score (objective assessment) of 80 or less.
You will not qualify if you...
- Active or suspected latent infection in the affected joint at the time of procedure.
- Local, systemic, or distant infection that may affect or spread to the prosthetic joint.
- Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces preventing adequate prosthesis support or fixation.
- Diagnosis of neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease affecting the limb.
- Presence of a stable, painless arthrodesis in a functional position in the affected joint.
- Severe joint instability due to absence of collateral ligament integrity.
- Rheumatoid arthritis patients with skin ulcer, history of recurrent skin breakdown, or steroid use at screening.
- Requirement for simultaneous bilateral knee surgery.
- Pregnant or planning pregnancy during study participation.
- Clinically significant cognitive impairment, psychiatric illness, or other condition compromising safety or study assessment.
- Institutionalized patients or those with known drug or alcohol dependence currently or within the last year.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Advanced Orthopaedic Specialists
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
2
Bowen Hefley Orthopedics
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Community Foundation Medical Group
Fresno, California, United States, 93720
Withdrawn
4
Cornerstone Orthopaedics & Sports Medicine
Superior, Colorado, United States, 80027
Completed
5
Orthopaedic Associates, Inc.
Evansville, Indiana, United States, 47710
Completed
6
Jeff Yergler, LLC
Granger, Indiana, United States, 46530
Actively Recruiting
7
Arthroplasty Foundation Inc.
Louisville, Kentucky, United States, 40220
Completed
8
Ascension Providence Rochester Hospital
Rochester, Michigan, United States, 48307
Actively Recruiting
9
Michigan Orthopaedic Surgeons, PLLC
Southfield, Michigan, United States, 48076
Active, Not Recruiting
10
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota, United States, 55431
Completed
11
Thomas Aleto MD, PC
Columbia, Missouri, United States, 65201
Withdrawn
12
Orthopaedic Research Institute of New Jersey
Chester, New Jersey, United States, 07390
Actively Recruiting
13
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
ROC Orthopedics
Oregon City, Oregon, United States, 97045
Completed
15
Penn Medicine/ Lancaster General Health
Lancaster, Pennsylvania, United States, 17602
Completed
16
Orthopedic Surgeons of Wisconsin, SC
Wauwatosa, Wisconsin, United States, 53222
Withdrawn
Research Team
C
Chelsea Smith
CONTACT
C
Charles Jaggard
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
11
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