Actively Recruiting
Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System
Led by Zimmer Biomet · Updated on 2025-10-24
380
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Persona Revision Knee System in patients who have undergone primary or revision total knee arthroplasty (TKA). This multicenter, single-arm, retrospective cohort study with prospective follow-up aims to assess the device's performance, clinical benefits, and safety. The study focuses on patients treated with this system, which was commercially available from late 2019, with up to 380 patients across a maximum of 20 sites. The study involves patients implanted with various configurations of the Persona Revision Knee System including different tibial stems, tibial components, articular surfaces, and femoral components. Eligible patients will be identified retrospectively and invited for prospective follow-up visits at 1, 2, 3, 4, 5, 7, and 10 years after surgery. The retrospective portion includes data collected during routine care before the study. Participants will be monitored through regular assessments of knee function and safety outcomes. The primary outcome is the improvement in the Knee Society Clinical Rating System objective knee score at 2 years. Secondary outcomes include pain scores, knee injury and osteoarthritis outcome measures, and tracking of adverse events. Follow-up visits involve clinical evaluations to measure the device's performance and patient recovery over time.
CONDITIONS
Brief Title
Persona Revision Knee System Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at screening
- Signed informed consent approved by an institutional review board
- Willing and able to follow study procedures, visit schedules, and postoperative care instructions
- Previous diagnosis requiring treatment with the Persona Revision Knee System for conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, joint configuration loss, deformities, or failed prior surgeries
- 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 the 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
- Neuropathic arthropathy, osteoporosis, or neuromuscular disease affecting the limb
- Stable, painless arthrodesis in a functional joint position
- Severe joint instability due to absence of collateral ligament integrity
- Rheumatoid arthritis with skin ulcers, recurrent skin breakdown, or steroid use
- Need for simultaneous bilateral knee surgery
- Pregnant or planning pregnancy during study participation
- Significant cognitive impairment or psychiatric illness affecting safety or assessment
- Institutionalized or history of drug or alcohol dependence within the last year
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 - Retrospective plus up to 10 years postoperative follow-up
Participants who have previously received the Persona Revision Knee System implant per routine care are assessed retrospectively and invited for prospective data collection visits.
Visits at 1, 2, 3, 4, 5, 7, and 10 years postoperative
Duration - Up to 10 years postoperative
Participants undergo long-term follow-up assessments to monitor performance, safety, and clinical benefits of the implanted knee system.
Scheduled visits at multiple postoperative years as per study protocol
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
C
Charles Jaggard
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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