Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty

This is a prospective, multi-centre, non comparative, post market clinical follow-up study involving orthopaedic surgeons skilled in TKA and experienced implanting the devices included in this study.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)

Detailed Description

The objectives of the study are to document the implant survivorship and clinical outcomes data for the Persona fixed bearing implants used in primary total knee arthroplasty (TKA). The study will include a maximum of 20 centres and up to 1000 implanted knees. Each centre may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of outcomes across a variety of investigators and clinical settings.

• Study Type: Observational
• Enrollment (Actual): 1017

Contacts and Locations

Study Locations

• Australia
  • West Perth, Australia, 6160
    • Fremantle Hospital
• India
  • Bangalore, India, 560076,
    • Fortis Health Care, Bangalore
  • Delhi, India, 110029
    • All India Institute of Medical Sciences
  • Delhi, India, 110 054
    • Sant Parmanand Hospital
  • Hyderabad, India, 500085
    • Landmark Hospitals
  • Pune, India, 411004
    • Deenanath Mangeshkar Hospital
• Japan
  • Kochi, Japan, 783-8505
    • Kochi University Hospital
  • Tokyo, Japan, 101-8309
    • Nihon University Hospital
• Korea, Republic of
  • Gangneung, Korea, Republic of, 25440
    • GangNeung Asan Hospital
  • Hwasun, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 137-701
    • Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 110-460
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06973
    • Chungang University Hospital
  • Seoul, Korea, Republic of, 138-736
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Seoul Asan Medical Center
  • Yangsan, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
• New Zealand
  • Waikato
    • Hamilton, Waikato, New Zealand, 3204
      • Waikato Hospital
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study population will consist of patients who require primary TKA and satisfy eligible criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary TKA using the Persona fixed bearing knee system.

Description

Inclusion Criteria:

• Age 18 to 80 years old, inclusive

• Qualifies for a primary TKA based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

  1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
  2. Collagen disorders and/ or avascular necrosis of 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 that did not include partial or total knee arthroplasty of the ipsilateral knee.
• Participated in a study-related informed consent process.
• Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form.
• Willing and able to complete scheduled study procedures and follow-up evaluations.
• Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee system implanted in accordance with product labelling.

Exclusion Criteria:

• Currently participating in any other surgical intervention studies or pain management studies.
• Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
• Insufficient bone stock on femoral or tibial surfaces/
• Skeletal immaturity
• Neuropathic arthropathy
• Any loss of musculature or neuromuscular disease that compromises the affected limb.
• Stable, painless arthrodesis in a satisfactory functional position.
• Severe instability secondary to the absence of collateral ligament integrity.
• Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
• Known or suspected sensitivity or allergy to one or more of the implant materials.
• Pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)
• Previously received partial or total knee arthroplasty for the ipsilateral knee.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persona fixed bearing knee system; Persona fixed bearing knee system (All patients will received Persona fixed bearing knee system)	Device: Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survivorship	Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis	Up to 5 years post surgery
Adverse Events (Safety)	Safety based on incidence and frequency of adverse events	Up to 5 years post surgery
Clinical Performance	Clinical Performance measured by overall pain and function and qualify of life Measured using EQ5D questionnaire and Knee Society Score	Up to 5 years post surgery
Clinical Performance	Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee	Up to 5 years post surgery

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Myung Chul Lee, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2014
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 21, 2024

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CSA2014-02K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No