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 affectedjoint at the time of procedure.
Presence of of local/systemic/distant focal infection that may affect orhematogenously spread to the prosthetic joint.
Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces whichcannot provide adequate support and/or fixation to the prosthesis.
Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature orneuromuscular disease that compromises the affected limb.
Presence of a stable, painless arthrodesis in a satisfactory functional position inthe affected joint.
Severe instability of the affected joint secondary to the absence of collateralligament integrity.
Diagnosis of rheumatoid arthritis in conjunction with any of the following at thetime 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 opinionof the Investigator, could compromise patient safety or interfere with theassessment of the safety and treatment effects of the study procedure.
Any patient who is institutionalized, or with a known drug or alcoholdependence currently or within the last year.
Study Design
Study Description
Connect with a study center
Advanced Orthopaedic Specialists
Fayetteville, Arkansas 72703
United StatesActive - Recruiting
Bowen Hefley Orthopedics
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Community Foundation Medical Group
Fresno, California 93720
United StatesSite Not Available
Cornerstone Orthopaedics & Sports Medicine
Superior, Colorado 80027
United StatesCompleted
Orthopaedic Associates, Inc.
Evansville, Indiana 47710
United StatesCompleted
Jeff Yergler, LLC
Granger, Indiana 46530
United StatesActive - Recruiting
Arthroplasty Foundation Inc.
Louisville, Kentucky 40220
United StatesCompleted
Ascension Providence Rochester Hospital
Rochester, Michigan 48307
United StatesActive - Recruiting
Michigan Orthopaedic Surgeons, PLLC
Southfield, Michigan 48076
United StatesSite Not Available
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota 55431
United StatesCompleted
Thomas Aleto MD, PC
Columbia, Missouri 65201
United StatesSite Not Available
Orthopaedic Research Institute of New Jersey
Chester, New Jersey 07390
United StatesActive - Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesActive - Recruiting
ROC Orthopedics
Oregon City, Oregon 97045
United StatesActive - Recruiting
Penn Medicine/ Lancaster General Health
Lancaster, Pennsylvania 17602
United StatesCompleted
Ortopedic Surgeons of Wisconsin, SC
Wauwatosa, Wisconsin 53222
United StatesSite Not Available
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