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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persona fixed bearing knee system | Persona fixed bearing knee system (All patients will received Persona fixed bearing knee system) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system) | Device |
|
| 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 |
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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:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Myung Chul Lee | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fremantle Hospital | West Perth | 6160 | Australia | |||
| Fortis Health Care, Bangalore |
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| Bangalore |
| 560076, |
| India |
| Sant Parmanand Hospital | Delhi | 110 054 | India |
| All India Institute of Medical Sciences | Delhi | 110029 | India |
| Landmark Hospitals | Hyderabad | 500085 | India |
| Deenanath Mangeshkar Hospital | Pune | 411004 | India |
| Kochi University Hospital | Kochi | 783-8505 | Japan |
| Nihon University Hospital | Tokyo | 101-8309 | Japan |
| Waikato Hospital | Hamilton | Waikato Region | 3204 | New Zealand |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| GangNeung Asan Hospital | Gangneung | 25440 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | 58128 | South Korea |
| Chungang University Hospital | Seoul | 06973 | South Korea |
| Seoul National University Hospital | Seoul | 110-460 | South Korea |
| Seoul St. Mary's Hospital | Seoul | 137-701 | South Korea |
| Samsung Medical Center | Seoul | 138-736 | South Korea |
| Seoul Asan Medical Center | Seoul | 138-736 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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