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The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively. The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters, and survivorship.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Sah Orthopaedic Associates
Fremont, California, United States
Panorama Orthopedics & Spine Center
Golden, Colorado, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
Henry County Orthopedics and Sports Medicine
New Castle, Indiana, United States
Sports Medicine North
Beverly, Massachusetts, United States
Troy Orthopaedic Associates
Troy, Michigan, United States
New Mexico Orthopaedics
Albuquerque, New Mexico, United States
Midlands Orthopaedics & Neurosurgery
Columbia, South Carolina, United States
Skagit Regional Clinics-Riverbend
Mount Vernon, Washington, United States
Orthopädisches Spital Speising
Vienna, Austria
Start Date
February 8, 2017
Primary Completion Date
September 1, 2027
Completion Date
July 1, 2029
Last Updated
February 24, 2025
643
ACTUAL participants
Persona Partial Knee system
DEVICE
Lead Sponsor
Zimmer Biomet
NCT07153471
NCT07351968
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06747494