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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.
Full 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.
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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
1,017 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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