Knee Pain ChronicOsteoarthritisRheumatoid ArthritisTraumatic ArthritisPolyarthritisModerate Varus, Valgus or Flexion DeformitiesAvascular Necrosis of the Femoral Condyle
Investigational drug(s) / intervention(s)
Zimmer Persona Total Knee System
Zimmer Persona Total Knee System: Primary Total Knee Arthroplasty
Study summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Patient 18-75 years of age, inclusive
* Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following: a) rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; b) collagen disorders and/or avascular necrosis of the femoral condyle; c) post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; d) moderate valgus, varus, or flexion deformities; or e) the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
* Patient has participated in a study-related Informed Consent process
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form
* Patient is willing and able to complete scheduled study procedures and follow-up evaluations
* Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling
Exclusion Criteria:
* Patient is currently participating in any other surgical intervention studies or pain management studies
* Previous history of infection in the affected joint and/or other local/systemic infection 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 compromises the affected limb
* Stable, painless arthrodesis in a satisfactory functional position
* Severe instability secondary to the absence of collateral ligament integrity
* Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
* Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
* Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
* Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Primary outcome measure(s)
Knee Society Score — 10 years Knee Society Score
Trial sites (14)
Facility
City
Region
Status
Colorado Joint Replacement
Denver
Colorado
Orthopaedic & Spine Center of the Rockies
Fort Collins
Colorado
Denver-Vail Orthopedics
Parker
Colorado
Rockford Orthopedic Associates
Rockford
Illinois
Henry County Orthopedics and Sports Medicine
New Castle
Indiana
UNC Department of Orthopaedics
Chapel Hill
North Carolina
OrthoCarolina
Charlotte
North Carolina
Raleigh Orthopaedic Clinic
Raleigh
North Carolina
Lindner Research Center
Cincinnati
Ohio
SportsMedicine Grant & Orthopaedic Associates
Columbus
Ohio
University of Pennsylvania
Philadelphia
Pennsylvania
Tennessee Orthopaedic Foundation for Education and Research
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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