Persona Revision Knee System Outcomes

Last updated: January 29, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

Persona Revision Knee System

Clinical Study ID

NCT04821154
CMG2019-13K
  • Ages > 18
  • All Genders

Study Summary

The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female of at least 18 years of age at the time of screening.

  2. Signed an institutional review board approved informed consent.

  3. Willingness and ability to comply with the study procedures and visit schedules andability to understand and follow oral and written post-operative care instructions.

  4. Previous medical diagnosis/ history of at least one of the following conditionsrequiring treatment using the Persona Revision Knee System within a pre-specifiedstudy variant configuration (cohort), in accordance with the instructions for use (IFU):

  5. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis

  6. Collagen disorders, and/or avascular necrosis of the femoral condyle

  7. Post-traumatic loss of joint configuration, particularly when there ispatellofemoral erosion, dysfunction or prior patellectomy

  8. Moderate valgus, varus, or flexion deformities

  9. The salvage of previously failed surgical attempts or for a knee in whichsatisfactory stability in flexion cannot be obtained at the time of surgery

  10. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.

Exclusion

Exclusion Criteria:

  1. Presence of clinically observed active or suspected latent infection in the affectedjoint at the time of procedure.

  2. Presence of of local/systemic/distant focal infection that may affect orhematogenously spread to the prosthetic joint.

  3. Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces whichcannot provide adequate support and/or fixation to the prosthesis.

  4. Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature orneuromuscular disease that compromises the affected limb.

  5. Presence of a stable, painless arthrodesis in a satisfactory functional position inthe affected joint.

  6. Severe instability of the affected joint secondary to the absence of collateralligament integrity.

  7. Diagnosis of rheumatoid arthritis in conjunction with any of the following at thetime of screening:

  1. An ulcer of the skin

  2. History of recurrent breakdown of the skin

  3. Use of steroids

  1. Patient requires simultaneous bilateral knee surgery for treatment of diagnosedcondition.

  2. Pregnant or women planning to become pregnant during the time they will beparticipating in the study.

  3. Any documented clinically significant degree of cognitive impairment or othercondition, finding, or psychiatric illness at screening which, in the opinionof the Investigator, could compromise patient safety or interfere with theassessment of the safety and treatment effects of the study procedure.

  4. Any patient who is institutionalized, or with a known drug or alcoholdependence currently or within the last year.

Study Design

Total Participants: 380
Treatment Group(s): 1
Primary Treatment: Persona Revision Knee System
Phase:
Study Start date:
June 14, 2021
Estimated Completion Date:
December 31, 2027

Study Description

Under study are the Persona® Revision Knee System (K181947 and K191625) implants and instrumentation, and any compatible devices being used in conjunction according to the Instructions for Use. This will be accomplished by retrospectively identifying patients who underwent primary or revision TKA with this system and inviting them to participate in prospective data collection at 1, 2, 3, 4, and 5-years postoperative follow-up. As the device was not available for commercial use until late 2019, the retrospective portion will involve those activities that occurred per standard of care for participants.

The primary endpoint for this study will be performance assessed by improvement in the 1989 Knee Society Clinical Rating System (KS) objective knee score (KS-KS) from baseline to 2 years (as evaluated using the overall group mean showing at least the Minimal Clinically Important Difference (MCID) of 5.4 points).

A maximum of 20 sites will contribute to this study. There will be a maximum of 380 patients enrolled in the study.

Connect with a study center

  • Advanced Orthopaedic Specialists

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Bowen Hefley Orthopedics

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Community Foundation Medical Group

    Fresno, California 93720
    United States

    Site Not Available

  • Cornerstone Orthopaedics & Sports Medicine

    Superior, Colorado 80027
    United States

    Completed

  • Orthopaedic Associates, Inc.

    Evansville, Indiana 47710
    United States

    Completed

  • Jeff Yergler, LLC

    Granger, Indiana 46530
    United States

    Active - Recruiting

  • Arthroplasty Foundation Inc.

    Louisville, Kentucky 40220
    United States

    Completed

  • Ascension Providence Rochester Hospital

    Rochester, Michigan 48307
    United States

    Active - Recruiting

  • Michigan Orthopaedic Surgeons, PLLC

    Southfield, Michigan 48076
    United States

    Site Not Available

  • TRIA Orthopaedic Center Research Institute

    Bloomington, Minnesota 55431
    United States

    Completed

  • Thomas Aleto MD, PC

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Orthopaedic Research Institute of New Jersey

    Chester, New Jersey 07390
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • ROC Orthopedics

    Oregon City, Oregon 97045
    United States

    Active - Recruiting

  • Penn Medicine/ Lancaster General Health

    Lancaster, Pennsylvania 17602
    United States

    Completed

  • Ortopedic Surgeons of Wisconsin, SC

    Wauwatosa, Wisconsin 53222
    United States

    Site Not Available

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