Phase
Condition
Rheumatoid Arthritis
Osteoarthritis
Osteomyelitis
Treatment
Total Knee Arthroplasty
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is of legal age and skeletally mature
Patient is willing and able to provide written Informed Consent by signing anddating the Institutional Review Board (IRB) / Ethics Committee (EC) approvedInformed Consent document
Patient is willing and able to complete scheduled follow-up evaluations as definedin the study protocol
Independent of study participation, patient qualifies for either cemented orcementless primary or revision total knee arthroplasty (including salvage ofpreviously failed surgical attempts) based upon physical exam and medical history,and meets the approved indications for use of the commercially available PersonaKnee System with appropriately matched Zimmer Biomet components implanted inaccordance with product labeling
Exclusion
Exclusion Criteria:
Patient is currently participating in any other surgical intervention or painmanagement study
Patient is pregnant or considered a member of a protected (vulnerable) populationwhose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
Patient has a mental or neurological condition who is unwilling or incapable offollowing postoperative care instructions
Patient has a condition which would, in the judgment of the investigator, place thepatient at undue risk or interfere with the conduct of the study
Patient is institutionalized or is a known drug abuser, a known alcoholic or cannotunderstand the requirements of study participation
Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
Previous history of infection in the affected joint and/or other local/systemicinfection that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
Neuropathic arthropathy
Osteoporosis or any loss of musculature or neuromuscular disease that compromisesthe affected limb
A stable, painless arthrodesis in a satisfactory functional position
Severe instability secondary to the absence of collateral ligament integrity
Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history ofrecurrent breakdown of the skin
Patient has a > 5˚ valgus deformity with a medial collateral ligament (MCL)insufficiency, and the surgeon intends to use the personalized alignment surgicaltechnique
Study Design
Study Description
Connect with a study center
Denver Hip & Knee, Inc.
Parker, Colorado 80138
United StatesSite Not Available
Denver Hip & Knee, Inc.
Parker 5434006, Colorado 5417618 80138
United StatesActive - Recruiting
Foundation for Orthopaedic Research & Education
Tampa, Florida 33607
United StatesSite Not Available
Foundation for Orthopaedic Research & Education
Tampa 4174757, Florida 4155751 33607
United StatesActive - Recruiting
Northside Hospital, Inc.
Atlanta, Georgia 30342
United StatesSite Not Available
Northside Hospital, Inc.
Atlanta 4180439, Georgia 4197000 30342
United StatesActive - Recruiting
U of L Health
Louisville, Kentucky 40202
United StatesSite Not Available
U of L Health
Louisville 4299276, Kentucky 6254925 40202
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55902
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55902
United StatesActive - Recruiting
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi 39202
United StatesSite Not Available
Mississippi Sports Medicine and Orthopaedic Center
Jackson 4431410, Mississippi 4436296 39202
United StatesActive - Recruiting
New Mexico Orthopaedic Associates
Albuquerque, New Mexico 87110
United StatesSite Not Available
New Mexico Orthopaedic Associates
Albuquerque 5454711, New Mexico 5481136 87110
United StatesActive - Recruiting
Syracuse Orthopaedic Specialists
DeWitt, New York 13214
United StatesSite Not Available
NYU
New York, New York 11016
United StatesSite Not Available
St. Francis Hospital & Heart Center
Roslyn, New York 11576
United StatesSite Not Available
Syracuse Orthopaedic Specialists
DeWitt 5114617, New York 5128638 13214
United StatesActive - Recruiting
NYU
New York 5128581, New York 5128638 11016
United StatesActive - Recruiting
St. Francis Hospital & Heart Center
Roslyn 5134415, New York 5128638 11576
United StatesActive - Recruiting
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina 28207
United StatesSite Not Available
Duke University
Morrisville, North Carolina 27560
United StatesSite Not Available
OrthoCarolina Research Institute, Inc.
Charlotte 4460243, North Carolina 4482348 28207
United StatesActive - Recruiting
Duke University
Morrisville 4480285, North Carolina 4482348 27560
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
Southern Joint Replacement Institute
Nashville, Tennessee 37203
United StatesSite Not Available
UT Health at Houston
Houston, Texas 77030
United StatesSite Not Available
UT Health at Houston
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
UVA Health Orthopedic Center
Charlottesville, Virginia 22903
United StatesSite Not Available
UVA Health Orthopedic Center
Charlottesville 4752031, Virginia 6254928 22903
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.