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.
Study Type
OBSERVATIONAL
Enrollment
1,017
Fremantle Hospital
West Perth, Australia
Fortis Health Care, Bangalore
Bangalore, India
Implant Survivorship
Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis
Time frame: Up to 5 years post surgery
Adverse Events (Safety)
Safety based on incidence and frequency of adverse events
Time frame: 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
Time frame: 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
Time frame: Up to 5 years post surgery
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Delhi, India
All India Institute of Medical Sciences
Delhi, India
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Hyderabad, India
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Kochi, Japan
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Tokyo, Japan
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Hamilton, Waikato Region, New Zealand
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Singapore, Singapore
...and 8 more locations