Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
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Trial details
- Who runs it
- Zimmer Biomet
- Trial code
- NCT04461626
- Record updated
- 22 August 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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:; Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders and/ or avascular necrosis of femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus or flexion deformities; 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: 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; Previously received partial or total knee arthroplasty for the ipsilateral knee; Any loss of musculature or neuromuscular disease that compromises the affected limb; 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; Insufficient bone stock on femoral or tibial surfaces/; Skeletal immaturity; Neuropathic arthropathy; Stable, painless arthrodesis in a satisfactory functional position; Severe instability secondary to the absence of collateral ligament integrity; Pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.).