Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient is of legal age and skeletally mature
• Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document
• Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
• Independent of study participation, patient qualifies for either cemented or cementless primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling
Locations
United States
Colorado
Denver Hip & Knee, Inc.
RECRUITING
Parker
Florida
Foundation for Orthopaedic Research & Education
RECRUITING
Tampa
Georgia
Northside Hospital, Inc.
RECRUITING
Atlanta
Kentucky
U of L Health
RECRUITING
Louisville
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
RECRUITING
Rochester
Mississippi
Mississippi Sports Medicine and Orthopaedic Center
RECRUITING
Jackson
North Carolina
OrthoCarolina Research Institute, Inc.
RECRUITING
Charlotte
Duke University
RECRUITING
Morrisville
New Mexico
New Mexico Orthopaedic Associates
RECRUITING
Albuquerque
New York
Syracuse Orthopaedic Specialists
RECRUITING
Dewitt
NYU
RECRUITING
New York
St. Francis Hospital & Heart Center
RECRUITING
Roslyn
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Texas
UT Health at Houston
RECRUITING
Houston
Virginia
UVA Health Orthopedic Center
RECRUITING
Charlottesville
Contact Information
Primary
Erik Kowalski, PhD
erik.kowalski@zimmerbiomet.com
6473316652
Time Frame
Start Date:2023-06-28
Estimated Completion Date:2035-06
Participants
Target number of participants:760
Treatments
Cohort 1
Cementless Femur Cementless Tibia
Cohort 2
Cementless Femur Cementless Tibia
Cohort 3
Cemented Femur Cemented Tibia
Cohort 4
Cemented Femur Cemented Tibia
Cohort 5
Cementless Femur Cemented Tibia
Cohort 6
Cementless Femur Cemented Tibia
Cohort 7
Cementless Femur Cemented Tibia
Cohort 8
Cementless Femur Cemented Tibia
Cohort 9
Cementless Femur Cementless Tibia
Cohort 10
Cementless Femur Cementless Tibia
Cohort 11
Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.