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Persona Revision Knee System Outcomes

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ClinicalTrials.gov Identifier: NCT04821154
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Arthroplasty Complications Infection Knee Disease Knee Osteoarthritis Device: Persona Revision Knee System

Detailed 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 and 2-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.

Study Design
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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1) Revision Splined CCK
Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, constrained condylar knee (CCK) articular surface, Persona Revision femoral component, and splined femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
2) Revision Cemented CCK
Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, CCK articular surface, Persona Revision femoral component, and cemented femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
3) Revision Splined PS/CPS
Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, posterior stabilized/constrained posterior stabilized (PS/CPS) articular surface, Persona Revision femoral component, and splined femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
4) Revision Cemented PS/CPS
Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
5) Revision Splined PS/CPS
Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona primary PS femoral component, with no femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
6) Revision Cemented PS/CPS
Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, PS/CPS articular surface, Persona primary PS femoral component, with no femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
7) Revision Cemented CCK with 5 Degree Primary Tibia
Patients who were implanted with a cemented tibial stem, 5 degree Persona primary tibial component, CCK articular surface, Persona Revision femoral component, and cemented femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
8) Primary Splined CCK/CPS/PS with 0 Degree Tibia
Patients with a primary implant (non-revision case) who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and splined femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
9) Primary Cemented CCK/PS/CPS with 0 Degree Tibia
Patients with a primary implant (non-revision case) who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
10) Primary Cemented CCK/PS/CPS with 5 Degree Primary Tibia
Patients with a primary implant (non-revision case) who were implanted with a cemented tibial stem, 5 degree Persona primary tibial component, CCK/PS/CPS articular surface, Persona Revision femoral component, and cemented femoral stem.
 Device: Persona Revision Knee System
Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.


Outcome Measures
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Primary Outcome Measures :
  1. Knee Society Clinical Rating System objective knee score (KS-KS) [ Time Frame: 2 years ]

    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)

    The Knee Society objective knee score (KS-KS) assesses the knee joint by awarding points for pain, stability, and range of motion, with a minimum possible score of 0 and maximum possible score of 100. As described in Insall et al. (1989), "100 points will be obtained by a well-aligned knee prosthesis with no pain, [at least 121] degrees of motion, and negligible anteroposterior and mediolateral instability."



Secondary Outcome Measures :
  1. Incidence and frequency of adverse events. [ Time Frame: 2 years ]
    Safety of the device will be assessed by evaluating the incidence and frequency of adverse events including (re-)revision of any component during the study in accordance with Regulation (EU) 2017/745 - Medical Device Regulation (MDR) Article 80(2) as well as Medical Devices Coordination Group (MDCG) 2020-10/1.

  2. Numeric Rating Scale (NRS) Pain Score [ Time Frame: 2 years ]

    Performance and clinical benefits will be assessed by evaluating improvements in patient reported outcome measures (PROMs) of the Numeric Rating Scale (NRS) pain scores from baseline to 2 years.

    The Numeric Rating Scale (NRS) pain is scored on a scale of 0 to 10. A score of 0 indicates that the patient is experiencing no pain in their knee joint while a score of 10 indicates that the patient is experiencing the worst possible pain in their knee joint.


  3. Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) [ Time Frame: 2 years ]

    Performance and clinical benefits will be assessed by evaluating improvements in patient reported outcome measures (PROMs) for the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) subscale scores from baseline to 2 years.

    The Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr) is scored on a scale of 0 to 100. A score of 100 indicates that a patient is experiencing perfect knee health while a score of 0 indicates that a patient is experiencing total knee disability.



Other Outcome Measures:
  1. Radiographic Imaging [ Time Frame: 2 years ]
    Exploratory outcomes will include the evaluation of radiographic imaging as required for adverse event/complication reporting purposes with focus on the following parameters: radiolucency lines, component migration/subsidence, osteolysis, and localized osteopenia.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in need of a primary or revision total knee procedure who receive Persona Revision Knee implants who meet all the inclusion criteria and none of the exclusion criteria.
Criteria

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 and ability to understand and follow oral and written post-operative care instructions.

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

    1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
    2. Collagen disorders, and/or avascular necrosis of the femoral condyle
    3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
    4. Moderate valgus, varus, or flexion deformities
    5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery
  5. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.

Exclusion Criteria:

  1. Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure.
  2. Previous history of infection in the affected joint that may affect the prosthetic joint.
  3. Presence of or history of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint.
  4. Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.
  5. Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.
  6. Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint.
  7. Severe instability of the affected joint secondary to the absence of collateral ligament integrity.

  8. Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening:

    1. An ulcer of the skin
    2. History of recurrent breakdown of the skin
    3. Use of steroids
  9. Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.
  10. Pregnant or women planning to become pregnant during the time they will be participating in the study.
  11. Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the Investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study procedure.
  12. Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821154


Contacts
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Contact: Ann Blanton 574-253-5556 Ann.Blanton@zimmerbiomet.com
Contact: Charles Jaggard charles.jaggard@zimmerbiomet.com

Locations
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United States, Arkansas
Advanced Orthopaedic Specialists Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Natalie Jobe, PA       nhopkins@arkosm.com   
Principal Investigator: Christopher Arnold, MD         
Bowen Hefley Orthopedics Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Lindsey Reynolds    501-663-6455    lindsey.reynolds@bowenhefleyortho.com   
Principal Investigator: Paul Edwards, MD         
United States, California
Community Foundation Medical Group Recruiting
Fresno, California, United States, 93720
Contact: Jennfier Steger    559-256-5396    jsteger@spoc-ortho.com   
Principal Investigator: Matthew Simons, MD         
United States, Colorado
Cornerstone Orthopaedics & Sports Medicine Active, not recruiting
Superior, Colorado, United States, 80027
United States, Indiana
Orthopaedic Associates, Inc. Recruiting
Evansville, Indiana, United States, 47710
Contact: Teresa Schoultz    812-424-9291    teresa.schoultz@oaevansville.com   
Principal Investigator: Anthony Czaplicki, MD         
Jeff Yergler, LLC Recruiting
Granger, Indiana, United States, 46530
Contact: Derek Yocum, PhD    865-360-9042    dyocum@sbortho.com   
Principal Investigator: Jeffrey Yergler, MD         
United States, Kentucky
Arthroplasty Foundation Inc. Recruiting
Louisville, Kentucky, United States, 40220
Contact: Jan Empson    502-364-0902    jempson@prortho.net   
Principal Investigator: Tyler Keller, MD         
United States, Michigan
Ascension Providence Rochester Hospital Recruiting
Rochester, Michigan, United States, 48307
Contact: Kathryn Mabee    248-609-9137    Kathryn.mabee@ascension.org   
Principal Investigator: Nicholas Frisch, MD         
United States, Missouri
Thomas Aleto MD, PC Recruiting
Columbia, Missouri, United States, 65201
Contact: Rachel Winingear    573-876-8400    r.winingear@columbiaorthogroup.com   
Principal Investigator: Thomas Aleto, MD         
United States, New Jersey
Orthopaedic Research Institute of New Jersey Recruiting
Chester, New Jersey, United States, 07390
Contact: Melissa Hough    908-684-3005    mhough@orthopedicnj.com   
Principal Investigator: John Dundon, MD         
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alison Klika       klikaa@ccf.org   
Principal Investigator: Michael Bloomfield, MD         
United States, Oregon
ROC Orthopedics Recruiting
Oregon City, Oregon, United States, 97045
Contact: Annette Tieu    503-213-1658    avotr@rocpdx.com   
Principal Investigator: James Ballard, MD         
United States, Pennsylvania
Penn Medicine/ Lancaster General Health Active, not recruiting
Lancaster, Pennsylvania, United States, 17602
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Charles Jaggard Zimmer Biomet
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT04821154    
Other Study ID Numbers: CMG2019-13K
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Zimmer Biomet:
Revision
Total Knee
Medical Device
Safety
 Performance
Primary
Clinical Benefits
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases