Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
NCT ID: NCT05787821
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
760 participants
OBSERVATIONAL
2023-06-28
2035-06-30
Brief Summary
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Detailed Description
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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 assessments include:
1. Confirming the safety, performance and clinical benefits of the Persona total knee system and instrumentation in primary and revision TKA.
2. Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Cementless Femur Cementless Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 2
Cementless Femur Cementless Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 3
Cemented Femur Cemented Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 4
Cemented Femur Cemented Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 5
Cementless Femur Cemented Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 6
Cementless Femur Cemented Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 7
Cementless Femur Cemented Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 8
Cementless Femur Cemented Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 9
Cementless Femur Cementless Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 10
Cementless Femur Cementless Tibia
Total Knee Arthroplasty
Total knee replacement.
Cohort 11
Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.
Total Knee Arthroplasty
Total knee replacement.
Cohort 12
Cementless Femur Cementless Tibia Cementless Patella
Total Knee Arthroplasty
Total knee replacement.
Interventions
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Total Knee Arthroplasty
Total knee replacement.
Eligibility Criteria
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Inclusion Criteria
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 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
Exclusion Criteria
2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
3. Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions
4. 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
5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
6. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
7. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
8. Insufficient bone stock on femoral or tibial surfaces
9. Neuropathic arthropathy
10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
11. A stable, painless arthrodesis in a satisfactory functional position
12. Severe instability secondary to the absence of collateral ligament integrity
13. Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
14. Patient has a \> 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Hillary Overholser
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Denver Hip & Knee, Inc.
Parker, Colorado, United States
Foundation for Orthopaedic Research & Education
Tampa, Florida, United States
Northside Hospital, Inc.
Atlanta, Georgia, United States
U of L Health
Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States
New Mexico Orthopaedic Associates
Albuquerque, New Mexico, United States
Syracuse Orthopaedic Specialists
DeWitt, New York, United States
NYU
New York, New York, United States
St. Francis Hospital & Heart Center
Roslyn, New York, United States
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
Duke University
Morrisville, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
UT Health at Houston
Houston, Texas, United States
UVA Health Orthopedic Center
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Amy Gridley
Role: primary
Anne Meredith Baldy
Role: primary
Langan Smith
Role: primary
Jana Robinson
Role: primary
Kimberly Albrecht
Role: primary
Travis Behm
Role: primary
Daniel Waren
Role: primary
Elizabeth Haag
Role: primary
Shannon O'Neal
Role: primary
Jennifer Friend
Role: primary
Karen Schemmel
Role: primary
Layla Haidar
Role: primary
Other Identifiers
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CMU2022-39K
Identifier Type: -
Identifier Source: org_study_id
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