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Active, not recruiting Observational

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

NCT05787821 · tracked via the Priya Life Science Mexico tracker
Phase
Observational
Started
2023-06-28
Last updated
2026-07-10

Condition(s) studied

Knee Pain ChronicOsteoarthritis, KneeRheumatoid ArthritisTraumatic ArthritisPolyarthritisVarus DeformityValgus DeformityFlexion Deformity of KneeAvascular Necrosis

Investigational drug(s) / intervention(s)

Total Knee Arthroplasty

Total Knee Arthroplasty: Total knee replacement.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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 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

Primary outcome measure(s)

  • Oxford Knee Score (OKS) — 5 years
    A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.

Trial sites (16)

FacilityCityRegionStatus
Denver Hip & Knee, Inc. Parker Colorado
Foundation for Orthopaedic Research & Education Tampa Florida
Northside Hospital, Inc. Atlanta Georgia
U of L Health Louisville Kentucky
University of Michigan Ann Arbor Michigan
Mayo Clinic Rochester Minnesota
Mississippi Sports Medicine and Orthopaedic Center Jackson Mississippi
New Mexico Orthopaedic Associates Albuquerque New Mexico
Syracuse Orthopaedic Specialists DeWitt New York
NYU New York New York
St. Francis Hospital & Heart Center Roslyn New York
OrthoCarolina Research Institute, Inc. Charlotte North Carolina
Duke University Morrisville North Carolina
Cleveland Clinic Cleveland Ohio
UT Health at Houston Houston Texas
UVA Health Orthopedic Center Charlottesville Virginia

More Zimmer Biomet trials in Mexico

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05787821 on ClinicalTrials.gov ↗ ← All trials in Mexico