Recruiting

Observational Study

Sponsor:

Zimmer Biomet

Code:

NCT04821154

Conditions

Arthroplasty Complications

Infection

Knee Disease

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Persona Revision Knee System

Study Details

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.

Conditions

Arthroplasty Complications

Infection

Knee Disease

Knee Osteoarthritis

Study ID

NCT04821154

Start date

Jun 14, 2021

Status verified date

May, 2026

Completion date

Dec 31, 2033

Anticipated

Primary completion date

Dec 31, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

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.

Study Design

Enrollment

380 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

Interventions

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.

Primary outcome measure

  • Knee Society Clinical Rating System objective knee score (KS-KS) [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Advanced Orthopaedic Specialists

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Principal Investigator:

Christopher Arnold, MD

Bowen Hefley Orthopedics

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Paul Edwards, MD

Jeff Yergler, LLC

Recruiting

Granger, Indiana, United States, 46530

Contacts

Principal Investigator:

Jeffrey Yergler, MD

Ascension Providence Rochester Hospital

Recruiting

Rochester, Michigan, United States, 48307

Contacts

Principal Investigator:

Nicholas Frisch, MD

Michigan Orthopaedic Surgeons, PLLC

Recruiting

Southfield, Michigan, United States, 48076

Contacts

Principal Investigator:

Donald Knapke, MD

Orthopaedic Research Institute of New Jersey

Recruiting

Chester, New Jersey, United States, 07390

Contacts

Principal Investigator:

John Dundon, MD

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Alison Klika

klikaa@ccf.org

Anabelle Visperas

vispera@ccf.org

Principal Investigator:

Michael Bloomfield, MD

More Information

Sponsor

Zimmer Biomet

Last update posted

Jul 10, 2026

Last verified

May, 2026

Keywords

  • Revision
  • Total Knee
  • Medical Device
  • Safety
  • Performance
  • Primary
  • Clinical Benefits

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zimmer Biomet on 2026-07-10.