Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
- Conditions
- Knee Osteoarthritis
- Registration Number
- NCT04461626
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Age 18 to 80 years old, inclusive<br><br> - Qualifies for a primary TKA based on physical exam and medical history, including<br> diagnosis of severe knee pain and disability due to at least one of the following:<br><br> 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.<br><br> 2. Collagen disorders and/ or avascular necrosis of femoral condyle.<br><br> 3. Post-traumatic loss of joint configuration, particularly when there is<br> patellofemoral erosion, dysfunction or prior patellectomy.<br><br> 4. Moderate valgus, varus or flexion deformities.<br><br> 5. The salvage of previously failed surgical attempts that did not include partial<br> or total knee arthroplasty of the ipsilateral knee.<br><br> - Participated in a study-related informed consent process.<br><br> - Willing and able to provide written informed consent by signing and dating the<br> IRB/EC approved informed consent form.<br><br> - Willing and able to complete scheduled study procedures and follow-up evaluations.<br><br> - Independent of study participation, patient is a candidate for commercially<br> available Persona fixed bearing knee system implanted in accordance with product<br> labelling.<br><br>Exclusion Criteria:<br><br> - Currently participating in any other surgical intervention studies or pain<br> management studies.<br><br> - Previous history of infection in the affected joint and/or other local/systemic<br> infection that may affect the prosthetic joint.<br><br> - Insufficient bone stock on femoral or tibial surfaces/<br><br> - Skeletal immaturity<br><br> - Neuropathic arthropathy<br><br> - Any loss of musculature or neuromuscular disease that compromises the affected limb.<br><br> - Stable, painless arthrodesis in a satisfactory functional position.<br><br> - Severe instability secondary to the absence of collateral ligament integrity.<br><br> - Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent<br> breakdown of the skin.<br><br> - Known or suspected sensitivity or allergy to one or more of the implant materials.<br><br> - Pregnant or considered a member of a protected population (e.g. prisoner, mentally<br> incompetent, etc.)<br><br> - Previously received partial or total knee arthroplasty for the ipsilateral knee.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Implant Survivorship;Adverse Events (Safety);Clinical Performance;Clinical Performance
- Secondary Outcome Measures
Name Time Method