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Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

NCT05787821 · Zimmer Biomet
In plain English

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Official title
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
About this study
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 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).
Eligibility criteria
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 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: 1. Patient is currently participating in any other surgical intervention or pain management study 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
Study design
Enrollment target: 760 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-06-28
Estimated completion: 2035-06
Last updated: 2026-01-20
Interventions
Device: Total Knee Arthroplasty
Primary outcomes
  • Oxford Knee Score (OKS) (5 years)
Sponsor
Zimmer Biomet · industry
Contacts & investigators
ContactErik Kowalski, PhD · contact · erik.kowalski@zimmerbiomet.com · 6473316652
InvestigatorHillary Overholser · study_director, Zimmer Biomet
All locations (16)
Denver Hip & Knee, Inc.Recruiting
Parker, Colorado, United States
Foundation for Orthopaedic Research & EducationRecruiting
Tampa, Florida, United States
Northside Hospital, Inc.Active Not Recruiting
Atlanta, Georgia, United States
U of L HealthRecruiting
Louisville, Kentucky, United States
University of MichiganActive Not Recruiting
Ann Arbor, Michigan, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Mississippi Sports Medicine and Orthopaedic CenterActive Not Recruiting
Jackson, Mississippi, United States
New Mexico Orthopaedic AssociatesRecruiting
Albuquerque, New Mexico, United States
Syracuse Orthopaedic SpecialistsRecruiting
DeWitt, New York, United States
NYURecruiting
New York, New York, United States
St. Francis Hospital & Heart CenterRecruiting
Roslyn, New York, United States
OrthoCarolina Research Institute, Inc.Recruiting
Charlotte, North Carolina, United States
Duke UniversityRecruiting
Morrisville, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
UT Health at HoustonRecruiting
Houston, Texas, United States
UVA Health Orthopedic CenterActive Not Recruiting
Charlottesville, Virginia, United States
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty) · TrialPath