Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Part of paid clinical trials in Parker, Colorado.

Sponsor
Zimmer Biomet
Study ID
NCT05787821
Status
Recruiting
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Conditions

  • Avascular Necrosis
  • Flexion Deformity of Knee
  • Knee Pain Chronic
  • Osteoarthritis, Knee
  • Polyarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Valgus Deformity
  • Varus Deformity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total Knee Arthroplasty — DEVICE
    Total knee replacement.

Study Details

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

Key Dates

Start date
Jun 28, 2023
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2035

Study Design

Enrollment
760 participants (estimated)

Arms

  • Arm: Cohort 1
    Cementless Femur Cementless Tibia
  • Arm: Cohort 2
    Cementless Femur Cementless Tibia
  • Arm: Cohort 3
    Cemented Femur Cemented Tibia
  • Arm: Cohort 4
    Cemented Femur Cemented Tibia
  • Arm: Cohort 5
    Cementless Femur Cemented Tibia
  • Arm: Cohort 6
    Cementless Femur Cemented Tibia
  • Arm: Cohort 7
    Cementless Femur Cemented Tibia
  • Arm: Cohort 8
    Cementless Femur Cemented Tibia
  • Arm: Cohort 9
    Cementless Femur Cementless Tibia
  • Arm: Cohort 10
    Cementless Femur Cementless Tibia
  • Arm: Cohort 11
    Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.
  • Arm: Cohort 12
    Cementless Femur Cementless Tibia Cementless Patella

Primary Outcome Measure

Oxford Knee Score (OKS) [ Time Frame: 5 years ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Denver Hip & Knee, Inc.ParkerColorado80138
Amy Gridley
Derek Johnson, MD (PRINCIPAL_INVESTIGATOR)
Foundation for Orthopaedic Research & EducationTampaFlorida33607
Anne Meredith Baldy
Brian Palumbo, MD (PRINCIPAL_INVESTIGATOR)
Steven Lyons, MD (SUB_INVESTIGATOR)
Spencer Smith, DO (SUB_INVESTIGATOR)
Northside Hospital, Inc.AtlantaGeorgia30342-
U of L HealthLouisvilleKentucky40202
Langan Smith
James Baker, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55902
Jana Robinson
Rafael Sierra, MD (PRINCIPAL_INVESTIGATOR)
Tad Mabry, MD (SUB_INVESTIGATOR)
Mississippi Sports Medicine and Orthopaedic CenterJacksonMississippi39202-
New Mexico Orthopaedic AssociatesAlbuquerqueNew Mexico87110
Kimberly Albrecht
Krishna Tripuraneni, MD (PRINCIPAL_INVESTIGATOR)
Syracuse Orthopaedic SpecialistsDeWittNew York13214
Travis Behm
Seth Greenky, MD (PRINCIPAL_INVESTIGATOR)
Anthony Orio, MD (SUB_INVESTIGATOR)
Max Greenky, MD (SUB_INVESTIGATOR)
Kevin Kopko, MD (SUB_INVESTIGATOR)
NYUNew YorkNew York11016
Daniel Waren
Vinay Aggarwal, MD (PRINCIPAL_INVESTIGATOR)
Diren Arsoy, MD (SUB_INVESTIGATOR)
Eric Grossman, MD (SUB_INVESTIGATOR)
Morteza Meftah, MD (SUB_INVESTIGATOR)
Ivan Fernandez-Madrid, MD (SUB_INVESTIGATOR)
Claudette Lajam, MD (SUB_INVESTIGATOR)
St. Francis Hospital & Heart CenterRoslynNew York11576
Elizabeth Haag
Frank DiMaio, MD (PRINCIPAL_INVESTIGATOR)
OrthoCarolina Research Institute, Inc.CharlotteNorth Carolina28207
Shannon O'Neal
Jesse Otero, MD (PRINCIPAL_INVESTIGATOR)
John Masonis, MD (SUB_INVESTIGATOR)
Keith Fehring, MD (SUB_INVESTIGATOR)
Duke UniversityMorrisvilleNorth Carolina27560
Jennifer Friend
Sean Ryan, MD (PRINCIPAL_INVESTIGATOR)
Michael Bolognesi, MD (SUB_INVESTIGATOR)
Samuel Wellman, MD (SUB_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Karen Schemmel
Nicolas Piuzzi, MD (PRINCIPAL_INVESTIGATOR)
UT Health at HoustonHoustonTexas77030
Layla Haidar
David Rodriguez-Quintana, MD (PRINCIPAL_INVESTIGATOR)
Adam Freedhand, MD (SUB_INVESTIGATOR)
UVA Health Orthopedic CenterCharlottesvilleVirginia22903-

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By research site
Denver Hip & Knee, Inc.· Parker, COFoundation for Orthopaedic Research & Education· Tampa, FLNorthside Hospital, Inc.· Atlanta, GAU of L Health· Louisville, KYUniversity of Michigan· Ann Arbor, MIMayo Clinic· Rochester, MN

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