Phase
Condition
Osteoarthritis
Knee Injuries
Treatment
Persona Revision Knee System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 andability to understand and follow oral and written post-operative care instructions.
Previous medical diagnosis/ history of at least one of the following conditionsrequiring treatment using the Persona Revision Knee System within a pre-specifiedstudy variant configuration (cohort), in accordance with the instructions for use (IFU):
Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
Collagen disorders, and/or avascular necrosis of the femoral condyle
Post-traumatic loss of joint configuration, particularly when there ispatellofemoral erosion, dysfunction or prior patellectomy
Moderate valgus, varus, or flexion deformities
The salvage of previously failed surgical attempts or for a knee in whichsatisfactory stability in flexion cannot be obtained at the time of surgery
A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.
Exclusion
Exclusion Criteria:
Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure.
Presence of of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint.
Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.
Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.
Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint.
Severe instability of the affected joint secondary to the absence of collateral ligament integrity.
Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening:
An ulcer of the skin
History of recurrent breakdown of the skin
Use of steroids
Patient requires simultaneous bilateral knee surgery for treatment of diagnosedcondition.
Pregnant or women planning to become pregnant during the time they will beparticipating in the study.
Any documented clinically significant degree of cognitive impairment or othercondition, finding, or psychiatric illness at screening which, in the opinion of theInvestigator, could compromise patient safety or interfere with the assessment ofthe safety and treatment effects of the study procedure.
Any patient who is institutionalized, or with a known drug or alcohol dependencecurrently or within the last year.
Study Design
Study Description
Connect with a study center
Advanced Orthopaedic Specialists
Fayetteville, Arkansas 72703
United StatesSite Not Available
Bowen Hefley Orthopedics
Little Rock, Arkansas 72205
United StatesSite Not Available
Advanced Orthopaedic Specialists
Fayetteville 4110486, Arkansas 4099753 72703
United StatesActive - Recruiting
Bowen Hefley Orthopedics
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - Recruiting
Community Foundation Medical Group
Fresno, California 93720
United StatesSite Not Available
Community Foundation Medical Group
Fresno 5350937, California 5332921 93720
United StatesSite Not Available
Cornerstone Orthopaedics & Sports Medicine
Superior, Colorado 80027
United StatesSite Not Available
Cornerstone Orthopaedics & Sports Medicine
Superior 5440838, Colorado 5417618 80027
United StatesCompleted
Orthopaedic Associates, Inc.
Evansville, Indiana 47710
United StatesSite Not Available
Jeff Yergler, LLC
Granger, Indiana 46530
United StatesSite Not Available
Orthopaedic Associates, Inc.
Evansville 4257227, Indiana 4921868 47710
United StatesCompleted
Jeff Yergler, LLC
Granger 4920869, Indiana 4921868 46530
United StatesActive - Recruiting
Arthroplasty Foundation Inc.
Louisville, Kentucky 40220
United StatesSite Not Available
Arthroplasty Foundation Inc.
Louisville 4299276, Kentucky 6254925 40220
United StatesCompleted
Ascension Providence Rochester Hospital
Rochester, Michigan 48307
United StatesSite Not Available
Michigan Orthopaedic Surgeons, PLLC
Southfield, Michigan 48076
United StatesSite Not Available
Ascension Providence Rochester Hospital
Rochester 5007400, Michigan 5001836 48307
United StatesActive - Recruiting
Michigan Orthopaedic Surgeons, PLLC
Southfield 5010636, Michigan 5001836 48076
United StatesSite Not Available
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota 55431
United StatesSite Not Available
TRIA Orthopaedic Center Research Institute
Bloomington 5018739, Minnesota 5037779 55431
United StatesCompleted
Thomas Aleto MD, PC
Columbia, Missouri 65201
United StatesSite Not Available
Thomas Aleto MD, PC
Columbia 4381982, Missouri 4398678 65201
United StatesSite Not Available
Orthopaedic Research Institute of New Jersey
Chester, New Jersey 07390
United StatesSite Not Available
Orthopaedic Research Institute of New Jersey
Chester 5096523, New Jersey 5101760 07390
United StatesActive - Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
ROC Orthopedics
Oregon City, Oregon 97045
United StatesSite Not Available
ROC Orthopedics
Oregon City 5744253, Oregon 5744337 97045
United StatesCompleted
Penn Medicine/ Lancaster General Health
Lancaster, Pennsylvania 17602
United StatesSite Not Available
Penn Medicine/ Lancaster General Health
Lancaster 5197079, Pennsylvania 6254927 17602
United StatesCompleted
Ortopedic Surgeons of Wisconsin, SC
Wauwatosa, Wisconsin 53222
United StatesSite Not Available
Orthopedic Surgeons of Wisconsin, SC
Wauwatosa 5278159, Wisconsin 5279468 53222
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.