- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821154
Persona Revision Knee System Outcomes
Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System
Study Overview
Status
Intervention / Treatment
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, 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ann Blanton
- Phone Number: 574-253-5556
- Email: Ann.Blanton@zimmerbiomet.com
Study Contact Backup
- Name: Charles Jaggard
- Email: charles.jaggard@zimmerbiomet.com
Study Locations
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72703
- Recruiting
- Advanced Orthopaedic Specialists
-
Principal Investigator:
- Christopher Arnold, MD
-
Contact:
- Sydney Dale
- Phone Number: 479-316-4785
- Email: sdale@arkosm.com
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- Bowen Hefley Orthopedics
-
Principal Investigator:
- Paul Edwards, MD
-
Contact:
- Jackie Ross
- Phone Number: 501-663-6455
- Email: jackie.ross@bowenhefleyortho.com
-
-
California
-
Fresno, California, United States, 93720
- Completed
- Community Foundation Medical Group
-
-
Colorado
-
Superior, Colorado, United States, 80027
- Completed
- Cornerstone Orthopaedics & Sports Medicine
-
-
Indiana
-
Evansville, Indiana, United States, 47710
- Recruiting
- Orthopaedic Associates, Inc.
-
Contact:
- Teresa Schoultz
- Phone Number: 812-424-9291
- Email: teresa.schoultz@oaevansville.com
-
Principal Investigator:
- Anthony Czaplicki, MD
-
Granger, Indiana, United States, 46530
- Recruiting
- Jeff Yergler, LLC
-
Principal Investigator:
- Jeffrey Yergler, MD
-
Contact:
- Derek Yocum, PhD
- Phone Number: 865-360-9042
- Email: dyocum@sbortho.com
-
Contact:
- Emma Housholder
- Phone Number: 574-222-1822
- Email: ehousholder@sbortho.com
-
-
Kentucky
-
Louisville, Kentucky, United States, 40220
- Recruiting
- Arthroplasty Foundation Inc.
-
Contact:
- Jan Empson
- Phone Number: 502-364-0902
- Email: jempson@prortho.net
-
Principal Investigator:
- Tyler Keller, MD
-
-
Michigan
-
Rochester, Michigan, United States, 48307
- Recruiting
- Ascension Providence Rochester Hospital
-
Principal Investigator:
- Nicholas Frisch, MD
-
Contact:
- Kayla Chattinger
- Phone Number: 248-609-9137
- Email: kayla.chattinger@ascension.org
-
Southfield, Michigan, United States, 48076
- Active, not recruiting
- Michigan Orthopaedic Surgeons, PLLC
-
-
Minnesota
-
Bloomington, Minnesota, United States, 55431
- Completed
- TRIA Orthopaedic Center Research Institute
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Recruiting
- Thomas Aleto MD, PC
-
Contact:
- Rachel Winingear
- Phone Number: 573-876-8400
- Email: r.winingear@columbiaorthogroup.com
-
Principal Investigator:
- Thomas Aleto, MD
-
-
New Jersey
-
Chester, New Jersey, United States, 07390
- Recruiting
- Orthopaedic Research Institute of New Jersey
-
Principal Investigator:
- John Dundon, MD
-
Contact:
- Melissa Hough
- Phone Number: 908-684-3005
- Email: mhough@orthopedicnj.com
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- The Cleveland Clinic Foundation
-
Contact:
- Alison Klika
- Email: klikaa@ccf.org
-
Principal Investigator:
- Michael Bloomfield, MD
-
Contact:
- Anabelle Visperas
- Email: vispera@ccf.org
-
-
Oregon
-
Oregon City, Oregon, United States, 97045
- Recruiting
- ROC Orthopedics
-
Contact:
- Annette Tieu
- Phone Number: 503-213-1658
- Email: avotr@rocpdx.com
-
Principal Investigator:
- James Ballard, MD
-
-
Pennsylvania
-
Lancaster, Pennsylvania, United States, 17602
- Active, not recruiting
- Penn Medicine/ Lancaster General Health
-
-
Wisconsin
-
Wauwatosa, Wisconsin, United States, 53222
- Recruiting
- Ortopedic Surgeons of Wisconsin, SC
-
Contact:
- Melissa Ferguson
- Email: mferguson@theorthoinstitute.com
-
Principal Investigator:
- Thomas Parisi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female of at least 18 years of age at the time of screening.
- Signed an institutional review board approved informed consent.
- 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.
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):
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis
- Collagen disorders, and/or avascular necrosis of the femoral condyle
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus, or flexion deformities
- 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
- 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.
3) Presence of 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:
- An ulcer of the skin
- History of recurrent breakdown of the skin
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
11) Infection Cases
Any configuration of PRK components used for end stage (non-temporary) treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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." |
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
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. |
2 years
|
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. |
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Charles Jaggard, Zimmer Biomet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMG2019-13K
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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