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
Zimmer Biomet
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
Description
The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Total Knee System. The study will require each site to obtain institutional review board (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 total knee arthroplasty (TKA). Investigators will collect clinical data for a required 5 years. Follow-up clinical visits include 3 months, 1, 2, 5, 7 and 10 years post-operatively. Specific as…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient is of legal age and skeletally mature 2. 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 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol 4. 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 histor…
Interventions
- DeviceTotal Knee Arthroplasty
Total knee replacement.
Locations (16)
- Denver Hip & Knee, Inc.Parker, Colorado
- Foundation for Orthopaedic Research & EducationTampa, Florida
- Northside Hospital, Inc.Atlanta, Georgia
- U of L HealthLouisville, Kentucky
- University of MichiganAnn Arbor, Michigan
- Mayo ClinicRochester, Minnesota