Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
380 participants
OBSERVATIONAL
2021-06-14
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
No interventions assigned to this group
11) Infection Cases
Any configuration of PRK components used for end stage (non-temporary) treatment
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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:
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.
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Charles Jaggard
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Advanced Orthopaedic Specialists
Fayetteville, Arkansas, United States
Bowen Hefley Orthopedics
Little Rock, Arkansas, United States
Community Foundation Medical Group
Fresno, California, United States
Cornerstone Orthopaedics & Sports Medicine
Superior, Colorado, United States
Orthopaedic Associates, Inc.
Evansville, Indiana, United States
Jeff Yergler, LLC
Granger, Indiana, United States
Arthroplasty Foundation Inc.
Louisville, Kentucky, United States
Ascension Providence Rochester Hospital
Rochester, Michigan, United States
Michigan Orthopaedic Surgeons, PLLC
Southfield, Michigan, United States
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota, United States
Thomas Aleto MD, PC
Columbia, Missouri, United States
Orthopaedic Research Institute of New Jersey
Chester, New Jersey, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
ROC Orthopedics
Oregon City, Oregon, United States
Penn Medicine/ Lancaster General Health
Lancaster, Pennsylvania, United States
Orthopedic Surgeons of Wisconsin, SC
Wauwatosa, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMG2019-13K
Identifier Type: -
Identifier Source: org_study_id
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