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Persona Revision Knee System in people who had knee replacement surgery

Looks at how the Persona Revision Knee System works and its safety after knee replacement.

Key facts

Who runs it
Zimmer Biomet
Where
Bloomington, Chester, Cleveland, Columbia, Evansville, Fayetteville, Fresno, Granger, Lancaster, Little Rock, Louisville, Oregon City, Rochester, Southfield, Superior, and Wauwatosa, United StatesSee the 16 sites
Trial code
Registry title
Persona Revision Knee System Outcomes
Status
Recruiting
People taking part
380 people, planned
Started
14 Jun 2021
Expected to end
31 Dec 2033
Type of study
Observational, 11 groups
Treatments tested
  • Persona Revision Knee System
Record updated
10 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a first or repeat knee replacement with the Persona Revision Knee System. It studies how well the implant works and how safe it is.

Age
18 years and older
Sex
All sexes
Disease stage
Knee problems such as arthritis, joint damage after injury, moderate knee deformity, or a failed earlier knee surgery. Knee Society Knee Score before surgery of 80 or lower.
Earlier treatment
Must have received the Persona Revision Knee System in a first or repeat total knee replacement.

Main reasons for not taking part

  • Active or suspected infection in the knee, or an infection elsewhere that could spread to the implant
  • Too little or immature bone to hold the implant, osteoporosis, or nerve or muscle disease affecting the leg
  • Rheumatoid arthritis together with skin ulcers, repeated skin breakdown, or steroid use
  • Needing surgery on both knees at the same time
  • Pregnant or planning pregnancy, or drug or alcohol dependence within the last year

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure
  • Presence of of local/systemic/distant focal infection that may affect or hematogenously spread to the prosthetic joint
  • Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb
  • An ulcer of the skin
  • History of recurrent breakdown of the skin
  • Use of steroids; Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition; Pregnant or women planning to become pregnant during the time they will be participating in the study; 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; Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year
  • Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis
  • Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint
  • Severe instability of the affected joint secondary to the absence of collateral ligament integrity
  • Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening:

Where in United States

  • TRIA Orthopaedic Center Research InstituteBloomington, United StatesContact: Chelsea SmithNo longer taking part
  • Orthopaedic Research Institute of New JerseyChester, United StatesContact: Melissa HoughTaking people
  • The Cleveland Clinic FoundationCleveland, United StatesContact: Alison KlikaTaking people
  • Thomas Aleto MD, PCColumbia, United StatesContact: Chelsea SmithNo longer taking part
  • Orthopaedic Associates, Inc.Evansville, United StatesContact: Chelsea SmithNo longer taking part
  • Advanced Orthopaedic SpecialistsFayetteville, United StatesContact: Sydney DaleTaking people
  • Community Foundation Medical GroupFresno, United StatesContact: Chelsea SmithNo longer taking part
  • Jeff Yergler, LLCGranger, United StatesContact: Derek Yocum, PhDTaking people
  • Penn Medicine Lancaster General HealthLancaster, United StatesContact: Chelsea SmithNo longer taking part
  • Bowen Hefley OrthopedicsLittle Rock, United StatesContact: Jackie RossTaking people
  • Arthroplasty Foundation Inc.Louisville, United StatesContact: Chelsea SmithNo longer taking part
  • ROC OrthopedicsOregon City, United StatesContact: Chelsea SmithNo longer taking part
  • Ascension Providence Rochester HospitalRochester, United StatesContact: Kayla ChattingerTaking people
  • Michigan Orthopaedic Surgeons, PLLCSouthfield, United StatesContact: Randa HakimTaking people
  • Cornerstone Orthopaedics & Sports MedicineSuperior, United StatesContact: Chelsea SmithNo longer taking part
  • Orthopedic Surgeons of Wisconsin, SCWauwatosa, United StatesContact: Chelsea SmithNo longer taking part

About the trial

What the trial wants to find out

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.

The 11 groups in the trial

  • 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: 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.

    Treatment: 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System
Plain-language title
Persona Revision Knee System in people who had knee replacement surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
10 July 2026