Arthroplasty ComplicationsNCT04821154
Persona Revision Knee System Outcomes
An observational study of Arthroplasty Complications and Infection, run by Zimmer Biomet at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty Complications, Infection, Knee Disease
- What is being tested?
- Persona Revision Knee System
- Type of treatment
- Medical device
- How many people
- 380 participants
- Where
- 16 sitesUnited States
- Study dates
- 14 Jun 2021to 31 Dec 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Charles Jaggard contact
16 sites in 1 country
United States16 sites, 7 recruiting
- Completed
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota, 55431
- Recruiting
Orthopaedic Research Institute of New Jersey
Chester, New Jersey, 07390
Melissa Hough, 908-684-3005, mhough@orthopedicnj.com
John Dundon, MD
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Alison Klika, klikaa@ccf.org
Anabelle Visperas, vispera@ccf.org
- Withdrawn
Thomas Aleto MD, PC
Columbia, Missouri, 65201
- Completed
Orthopaedic Associates, Inc.
Evansville, Indiana, 47710
- Recruiting
Advanced Orthopaedic Specialists
Fayetteville, Arkansas, 72703
Sydney Dale, 479-316-4785, sdale@arkosm.com
Christopher Arnold, MD
- Withdrawn
Community Foundation Medical Group
Fresno, California, 93720
- Recruiting
Jeff Yergler, LLC
Granger, Indiana, 46530
Derek Yocum, PhD, 865-360-9042, dyocum@sbortho.com
Jeffrey Yergler, MD
- Completed
Penn Medicine/ Lancaster General Health
Lancaster, Pennsylvania, 17602
- Recruiting
Bowen Hefley Orthopedics
Little Rock, Arkansas, 72205
Jackie Ross, 501-663-6455, jackie.ross@bowenhefleyortho.com
Paul Edwards, MD
- Completed
Arthroplasty Foundation Inc.
Louisville, Kentucky, 40220
- Completed
ROC Orthopedics
Oregon City, Oregon, 97045
- Recruiting
Ascension Providence Rochester Hospital
Rochester, Michigan, 48307
Kayla Chattinger, 248-609-9137, kayla.chattinger@ascension.org
Nicholas Frisch, MD
- Recruiting
Michigan Orthopaedic Surgeons, PLLC
Southfield, Michigan, 48076
Randa Hakim, 248-244-9426, rhakim@miorthosurgeons.com
Donald Knapke, MD
- Completed
Cornerstone Orthopaedics & Sports Medicine
Superior, Colorado, 80027
- Withdrawn
Orthopedic Surgeons of Wisconsin, SC
Wauwatosa, Wisconsin, 53222
About this study
Official title: Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System
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.
Read the 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, 5, 7, and 10 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.
- Being tested
- Persona Revision Knee System
- Keywords
- Revision, Total Knee, Medical Device, Safety, Performance, Primary, Clinical Benefits
- Medical subject headings
- Infections, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona Revision Knee SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Persona Revision Knee System | |
| 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. Receives: Device: Persona Revision Knee System | |
| 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. Receives: Device: Persona Revision Knee System | |
| 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. Receives: Device: Persona Revision Knee System | |
| 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. Receives: Device: Persona Revision Knee System | |
| 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. Receives: Device: Persona Revision Knee System | |
| 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. Receives: Device: Persona Revision Knee System | |
| 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. Receives: Device: Persona Revision Knee System | |
| 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. Receives: Device: Persona Revision Knee System | |
| 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. | |
| 11) Infection Cases | Any configuration of PRK components used for end stage (non-temporary) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Clinical Rating System objective knee score (KS-KS)
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."
Measured: 2 years
Secondary outcomes (3)
Incidence and frequency of adverse events.
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.
Measured: 2 years
Numeric Rating Scale (NRS) Pain Score
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.
Measured: 2 years
Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start14 Jun 2021
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Jaggard, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821154
- Sponsor's protocol ID
- CMG2019-13K
- Status last verified
- May 2026
- First submitted
- 23 Mar 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes