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Clinical Trials in the USA / NCT02255383
Active, not recruiting Not applicable

Persona Total Knee Arthroplasty Outcomes Study

NCT02255383 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2014-07
Last updated
2026-03-10

Condition(s) studied

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)

Trial sites (14)

FacilityCityRegionStatus
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 Knoxville Tennessee
Texas Tech University Health Sciences Center Lubbock Texas
Jordan Young Institute Virginia Beach Virginia

More Zimmer Biomet trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT02255383 on ClinicalTrials.gov ↗ ← All trials in the USA