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NCT04461626 | COMPLETED | Knee Osteoarthritis

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

Condition or disease

Knee Osteoarthritis

Intervention/treatment

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
Estimated Enrollment : 1017 participants
Official Title : Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
Actual Study Start Date : 2014-11-19
Estimated Primary Completion Date : 2023-06-30
Estimated Study Completion Date : 2024-08-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Criteria
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.
Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty

Location Details

NCT04461626

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Australia,

Fremantle Hospital

West Perth, Australia, 6160

Not yet recruiting

India,

Fortis Health Care, Bangalore

Bangalore, India, 560076,

Not yet recruiting

India,

Sant Parmanand Hospital

Delhi, India, 110 054

Not yet recruiting

India,

All India Institute of Medical Sciences

Delhi, India, 110029

Not yet recruiting

India,

Landmark Hospitals

Hyderabad, India, 500085

Not yet recruiting

India,

Dinanath Mangeshkar Hospital

Pune, India, 411004

Not yet recruiting

Japan,

Kochi University Hospital

Kochi, Japan, 783-8505

Not yet recruiting

Japan,

Nihon University Hospital

Tokyo, Japan, 101-8309

Not yet recruiting

Korea, Republic of,

GangNeung Asan Hospital

Gangneung, Korea, Republic of, 25440

Not yet recruiting

Korea, Republic of,

Chonnam National University Hwasun Hospital

Hwasun, Korea, Republic of, 58128

Not yet recruiting

Korea, Republic of,

Chungang University Hospital

Seoul, Korea, Republic of, 06973

Not yet recruiting

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of, 110-460

Not yet recruiting

Korea, Republic of,

Seoul St. Mary's Hospital

Seoul, Korea, Republic of, 137-701

Not yet recruiting

Korea, Republic of,

Samsung Medical Center

Seoul, Korea, Republic of, 138-736

Not yet recruiting

Korea, Republic of,

Seoul Asan Medical Center

Seoul, Korea, Republic of, 138-736

Not yet recruiting

Korea, Republic of,

Pusan ​​National University Yangsan Hospital

Yangsan, Korea, Republic of, 50612

Not yet recruiting

New Zealand, Waikato

Waikato Hospital

Hamilton, Waikato, New Zealand, 3204

Not yet recruiting

Singapore,

Singapore General Hospital

Singapore, Singapore, 169608