Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
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
1 other identifier
observational
760
1 country
16
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 28, 2023
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2035
January 20, 2026
October 1, 2025
2.9 years
March 15, 2023
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxford Knee Score (OKS)
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.
5 years
Secondary Outcomes (2)
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
5 years
Pain and Satisfaction Numeric Rating Scale (NRS)
5 years
Study Arms (12)
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.
Cohort 12
Cementless Femur Cementless Tibia Cementless Patella
Interventions
Total knee replacement.
Eligibility Criteria
The study population will be a subset of the US population electing to proceed with total knee arthroplasty irrespective of participation in the study and: 1) who will be receiving one or more of the components of interest as part of standard clinical care, 2) agree to participate by completing a study-specific informed consent form, and 3) who satisfy the inclusion/exclusion criteria.
You may qualify if:
- 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
You may not qualify if:
- Patient is currently participating in any other surgical intervention or pain management study
- Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions
- Patient has a condition which would, in the judgment of the investigator, place the patient at undue risk or interfere with the conduct of the study
- Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
- Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
- 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
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- Patient has a \> 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (16)
Denver Hip & Knee, Inc.
Parker, Colorado, 80138, United States
Foundation for Orthopaedic Research & Education
Tampa, Florida, 33607, United States
Northside Hospital, Inc.
Atlanta, Georgia, 30342, United States
U of L Health
Louisville, Kentucky, 40202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, 39202, United States
New Mexico Orthopaedic Associates
Albuquerque, New Mexico, 87110, United States
Syracuse Orthopaedic Specialists
DeWitt, New York, 13214, United States
NYU
New York, New York, 11016, United States
St. Francis Hospital & Heart Center
Roslyn, New York, 11576, United States
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207, United States
Duke University
Morrisville, North Carolina, 27560, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
UT Health at Houston
Houston, Texas, 77030, United States
UVA Health Orthopedic Center
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hillary Overholser
Zimmer Biomet
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2023
First Posted
March 28, 2023
Study Start
June 28, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2035
Last Updated
January 20, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share