Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

July 9, 2026 updated by: Zimmer Biomet

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Estimated)

760

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Parker, Colorado, United States, 80138
        • Denver Hip & Knee, Inc.
    • Florida
      • Tampa, Florida, United States, 33607
        • Foundation for Orthopaedic Research & Education
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • U of L Health
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Mississippi Sports Medicine and Orthopaedic Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • New Mexico Orthopaedic Associates
    • New York
      • DeWitt, New York, United States, 13214
        • Syracuse Orthopaedic Specialists
      • New York, New York, United States, 11016
        • NYU
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital & Heart Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute, Inc.
      • Morrisville, North Carolina, United States, 27560
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • UT Health at Houston
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Health Orthopedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be a subset of the US population electing to proceed with total knee arthroplasty irrespective of participation in the study and: 1) who will be receiving one or more of the components of interest as part of standard clinical care, 2) agree to participate by completing a study-specific informed consent form, and 3) who satisfy the inclusion/exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Cementless Femur Cementless Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 2
Cementless Femur Cementless Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 3
Cemented Femur Cemented Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 4
Cemented Femur Cemented Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 5
Cementless Femur Cemented Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 6
Cementless Femur Cemented Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 7
Cementless Femur Cemented Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 8
Cementless Femur Cemented Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 9
Cementless Femur Cementless Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 10
Cementless Femur Cementless Tibia
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 11
Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.
Device: Total Knee Arthroplasty
Total knee replacement.
Cohort 12
Cementless Femur Cementless Tibia Cementless Patella
Device: Total Knee Arthroplasty
Total knee replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Knee Score (OKS)
Time Frame: 5 years
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
Time Frame: 5 years
A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health.
5 years
Pain and Satisfaction Numeric Rating Scale (NRS)
Time Frame: 5 years
Patients will rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). Along with their pain rating, subjects will be asked to rate their current satisfaction with their surgery from "Very Dissatisfied" to "Very Satisfied".
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Actual)

June 30, 2026

Study Completion (Estimated)

June 1, 2035

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMU2022-39K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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