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

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)

• Registration Number: NCT04461626
• Lead Sponsor: Zimmer Biomet

Brief Summary

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.

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 Timeline

• Study Start: 2014-11-19
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-08
• Status Verified: 2022-08
• Primary Completion: 2023-06-30
• Last Update Submitted: 2024-08-20
• Study Completion: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1017

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persona fixed bearing knee system	Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)	Persona fixed bearing knee system (All patients will received Persona fixed bearing knee system)

Primary Outcome Measures

Name	Time	Method
Adverse Events (Safety)	Up to 5 years post surgery	Safety based on incidence and frequency of adverse events
Clinical Performance	Up to 5 years post surgery	Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee
Implant Survivorship	Up to 5 years post surgery	Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis

Trial Locations

Locations (18)

Fremantle Hospital; 🇦🇺 West Perth, Australia

All India Institute of Medical Sciences; 🇮🇳 Delhi, India

Landmark Hospitals; 🇮🇳 Hyderabad, India

Deenanath Mangeshkar Hospital; 🇮🇳 Pune, India

Kochi University Hospital; 🇯🇵 Kochi, Japan

GangNeung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Chungang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of

Waikato Hospital; 🇳🇿 Hamilton, Waikato, New Zealand

Singapore General Hospital; 🇸🇬 Singapore, Singapore

Nihon University Hospital; 🇯🇵 Tokyo, Japan

Fortis Health Care, Bangalore; 🇮🇳 Bangalore, India

Sant Parmanand Hospital; 🇮🇳 Delhi, India