Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Last updated: October 22, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Osteoarthritis

Osteomyelitis

Treatment

Total Knee Arthroplasty

Clinical Study ID

NCT05787821
CMU2022-39K
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient is of legal age and skeletally mature

  2. Patient is willing and able to provide written Informed Consent by signing anddating the Institutional Review Board (IRB) / Ethics Committee (EC) approvedInformed Consent document

  3. Patient is willing and able to complete scheduled follow-up evaluations as definedin the study protocol

  4. Independent of study participation, patient qualifies for either cemented orcementless primary or revision total knee arthroplasty (including salvage ofpreviously failed surgical attempts) based upon physical exam and medical history,and meets the approved indications for use of the commercially available PersonaKnee System with appropriately matched Zimmer Biomet components implanted inaccordance with product labeling

Exclusion

Exclusion Criteria:

  1. Patient is currently participating in any other surgical intervention or painmanagement study

  2. Patient is pregnant or considered a member of a protected (vulnerable) populationwhose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)

  3. Patient has a mental or neurological condition who is unwilling or incapable offollowing postoperative care instructions

  4. Patient has a condition which would, in the judgment of the investigator, place thepatient 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 cannotunderstand 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/systemicinfection 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 compromisesthe 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 ofrecurrent 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 surgicaltechnique

Study Design

Total Participants: 760
Treatment Group(s): 1
Primary Treatment: Total Knee Arthroplasty
Phase:
Study Start date:
June 28, 2023
Estimated Completion Date:
June 30, 2035

Study 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 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).

Connect with a study center

  • Denver Hip & Knee, Inc.

    Parker, Colorado 80138
    United States

    Site Not Available

  • Denver Hip & Knee, Inc.

    Parker 5434006, Colorado 5417618 80138
    United States

    Active - Recruiting

  • Foundation for Orthopaedic Research & Education

    Tampa, Florida 33607
    United States

    Site Not Available

  • Foundation for Orthopaedic Research & Education

    Tampa 4174757, Florida 4155751 33607
    United States

    Active - Recruiting

  • Northside Hospital, Inc.

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Northside Hospital, Inc.

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Active - Recruiting

  • U of L Health

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • U of L Health

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55902
    United States

    Active - Recruiting

  • Mississippi Sports Medicine and Orthopaedic Center

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Mississippi Sports Medicine and Orthopaedic Center

    Jackson 4431410, Mississippi 4436296 39202
    United States

    Active - Recruiting

  • New Mexico Orthopaedic Associates

    Albuquerque, New Mexico 87110
    United States

    Site Not Available

  • New Mexico Orthopaedic Associates

    Albuquerque 5454711, New Mexico 5481136 87110
    United States

    Active - Recruiting

  • Syracuse Orthopaedic Specialists

    DeWitt, New York 13214
    United States

    Site Not Available

  • NYU

    New York, New York 11016
    United States

    Site Not Available

  • St. Francis Hospital & Heart Center

    Roslyn, New York 11576
    United States

    Site Not Available

  • Syracuse Orthopaedic Specialists

    DeWitt 5114617, New York 5128638 13214
    United States

    Active - Recruiting

  • NYU

    New York 5128581, New York 5128638 11016
    United States

    Active - Recruiting

  • St. Francis Hospital & Heart Center

    Roslyn 5134415, New York 5128638 11576
    United States

    Active - Recruiting

  • OrthoCarolina Research Institute, Inc.

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Duke University

    Morrisville, North Carolina 27560
    United States

    Site Not Available

  • OrthoCarolina Research Institute, Inc.

    Charlotte 4460243, North Carolina 4482348 28207
    United States

    Active - Recruiting

  • Duke University

    Morrisville 4480285, North Carolina 4482348 27560
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Southern Joint Replacement Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • UT Health at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • UT Health at Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • UVA Health Orthopedic Center

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • UVA Health Orthopedic Center

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

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