Persona Revision Knee System Outcomes

NCT04821154 | Recruiting FDA Device

• 1 other identifier: CMG2019-13K
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 16

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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."

  2 years

Secondary Outcomes (3)

• Incidence and frequency of adverse events.

  2 years

• Numeric Rating Scale (NRS) Pain Score

  2 years

• Knee Injury and Osteoarthritis Outcome Score Junior (KOOS-Jr)

  2 years

Other Outcomes (1)

• Radiographic Imaging

  2 years

Study Arms (11)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

Interventions

Persona Revision Knee System DEVICE

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.

1) Revision Splined CCK; 2) Revision Cemented CCK; 3) Revision Splined PS/CPS; 4) Revision Cemented PS/CPS; 5) Revision Splined PS/CPS; 6) Revision Cemented PS/CPS; 7) Revision Cemented CCK with 5 Degree Primary Tibia; 8) Primary Splined CCK/CPS/PS with 0 Degree Tibia; 9) Primary Cemented CCK/PS/CPS with 0 Degree Tibia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \) 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.
• \) Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and/or fixation to the prosthesis.
• \) Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.
• \) 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:
• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (16)

Advanced Orthopaedic Specialists

Fayetteville, Arkansas, 72703, United States

RECRUITING

Bowen Hefley Orthopedics

Little Rock, Arkansas, 72205, United States

RECRUITING

Community Foundation Medical Group

Fresno, California, 93720, United States

WITHDRAWN

Cornerstone Orthopaedics & Sports Medicine

Superior, Colorado, 80027, United States

COMPLETED

Orthopaedic Associates, Inc.

Evansville, Indiana, 47710, United States

COMPLETED

Jeff Yergler, LLC

Granger, Indiana, 46530, United States

RECRUITING

Arthroplasty Foundation Inc.

Louisville, Kentucky, 40220, United States

COMPLETED

Ascension Providence Rochester Hospital

Rochester, Michigan, 48307, United States

RECRUITING

Michigan Orthopaedic Surgeons, PLLC

Southfield, Michigan, 48076, United States

ACTIVE NOT RECRUITING

TRIA Orthopaedic Center Research Institute

Bloomington, Minnesota, 55431, United States

COMPLETED

Thomas Aleto MD, PC

Columbia, Missouri, 65201, United States

WITHDRAWN

Orthopaedic Research Institute of New Jersey

Chester, New Jersey, 07390, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

ROC Orthopedics

Oregon City, Oregon, 97045, United States

COMPLETED

Penn Medicine/ Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

COMPLETED

Orthopedic Surgeons of Wisconsin, SC

Wauwatosa, Wisconsin, 53222, United States

WITHDRAWN

MeSH Terms

Conditions

Infections; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Charles Jaggard

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Chelsea Smith

CONTACT

714-740-9438; chelsea.smith2@zimmerbiomet.com

Charles Jaggard

CONTACT

charles.jaggard@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 29, 2021
• Study Start: June 14, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 24, 2025

Record last verified: 2024-12

Locations

US (16)