Persona Revision Knee System Outcomes
Start Date
6/14/2021
Completion Date
12/31/2033
Summary
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.
Detailed Description
Under study are the Persona® Revision Knee System (K181947 and K191625) implants and instrumentation, and any compatible devices being used in conjunction according to the Instructions for Use. This will be accomplished by retrospectively identifying patients who underwent primary or revision TKA with this system and inviting them to participate in prospective data collection at 1, 2, 3, 4, 5, 7, and 10 years postoperative follow-up. As the device was not available for commercial use until late 2019, the retrospective portion will involve those activities that occurred per standard of care for participants. The primary endpoint for this study will be performance assessed by improvement in the 1989 Knee Society Clinical Rating System (KS) objective knee score (KS-KS) from baseline to 2 years (as evaluated using the overall group mean showing at least the Minimal Clinically Important Difference (MCID) of 5.4 points). A maximum of 20 sites will contribute to this study. There will be a maximum of 380 patients enrolled in the study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Persona Revision Knee System
Conditions
Locations
Advanced Orthopaedic Specialists
Fayetteville, Arkansas 72703
United States
Bowen Hefley Orthopedics
Little Rock, Arkansas 72205
United States
Community Foundation Medical Group
Fresno, California 93720
United States
Cornerstone Orthopaedics & Sports Medicine
Superior, Colorado 80027
United States
Orthopaedic Associates, Inc.
Evansville, Indiana 47710
United States
Jeff Yergler, LLC
Granger, Indiana 46530
United States
Arthroplasty Foundation Inc.
Louisville, Kentucky 40220
United States
Ascension Providence Rochester Hospital
Rochester, Michigan 48307
United States
Michigan Orthopaedic Surgeons, PLLC
Southfield, Michigan 48076
United States
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota 55431
United States
Thomas Aleto MD, PC
Columbia, Missouri 65201
United States
Orthopaedic Research Institute of New Jersey
Chester, New Jersey 07390
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
ROC Orthopedics
Oregon City, Oregon 97045
United States
Penn Medicine/ Lancaster General Health
Lancaster, Pennsylvania 17602
United States
Orthopedic Surgeons of Wisconsin, SC
Wauwatosa, Wisconsin 53222
United States