Phase
Condition
Osteoarthritis
Joint Injuries
Dermatomyositis (Connective Tissue Disease)
Treatment
Zimmer Biomet Persona Ti-Nidium Total Knee System
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 IRB-approved Informed Consent document
Patient is willing and able to complete scheduled follow-up evaluations as definedin the study protocol
Patient qualifies for total knee arthroplasty based upon physical exam and medicalhistory, and meets the approved indications for use of the Persona Ti-Nidium KneeSystem and Vivacit-E polyethylene articulating surface
Independent of study participation, patient is a candidate for the commerciallyavailable Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface,implanted in accordance with product labeling
Study Device Inclusion Criteria:
The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, 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.
Exclusion
Exclusion Criteria:
Patient is unwilling to sign the Informed Consent
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 neurologic condition who is unwilling or incapable offollowing postoperative care instructions
Patient has a condition which would, in the judgement 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
Study Device Exclusion Criteria
Previous history of infection in the affected joint and/or other local/systematicinfection that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
Skeletal immaturity
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
The kinematic alignment surgical technique is contraindicated for patients withgreater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency
Study Design
Study Description
Connect with a study center
Denver Hip & Knee, Inc.
Parker, Colorado 80134
United StatesSite Not Available
MedStar Health Research Institute
Hyattsville, Maryland 20782
United StatesSite Not Available
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi 39202
United StatesSite Not Available
New Mexico Orthopaedic Associates
Albuquerque, New Mexico 87110
United StatesSite Not Available
Duke University
Durham, North Carolina 27708
United StatesSite Not Available
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota 57701
United StatesSite Not Available
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