Zimmer Biomet, a global leader in orthopedics, has initiated a Post-Market Clinical Follow-up (PMCF) study for its Persona Solution PPS Femur device. Scheduled to begin recruitment shortly, the study assesses the device’s safety and performance for patients undergoing total knee arthroplasty.
In this article:
What is the study about?
The PMCF study focuses on the Persona Solution PPS Femur, a device intended for total knee arthroplasty. According to ClinicalTrials.gov, this study will evaluate the device’s long-term performance and safety for a specific group of knee arthritis patients.
Conditions being studied
The study targets patients with the following conditions:
- Rheumatoid arthritis
- Osteoarthritis of the knee
- Traumatic arthritis of the knee
- Polyarthritis
- Collagen disorders
- Avascular necrosis of the femoral condyle
- Valgus or varus deformities
- Flexion deformities of the knee
The medical device under investigation is designed to improve mobility and reduce pain for individuals who undergo total knee arthroplasty.
Who is affected?
This study is relevant to clinical, quality, and regulatory professionals and healthcare providers specializing in knee joint reconstruction. Patients who fit the specified conditions may also benefit directly from the study’s findings.
Not yet recruiting, the research will later target eligible candidates globally. If you are a healthcare provider, it may help inform treatment options and device selection.
Sponsor details and next steps
The study is sponsored by Zimmer Biomet, a company renowned for innovative solutions in orthopedics. Their commitment to PMCF studies is aligned with European Union Medical Devices Regulation (MDR) requirements, ensuring continued compliance and data-driven device advancements.
Recruitment for the study is expected soon, and interested investigators or institutions can monitor updates via the ClinicalTrials.gov listing. For full technical specifications and eligibility criteria, the listing page provides more details.
FAQ
- What is the primary goal of this study?
The study aims to collect real-world data on the safety and effectiveness of the Persona Solution PPS Femur device in total knee arthroplasty. - Is the study actively recruiting?
Not yet. Recruitment updates will be published on ClinicalTrials.gov. - Who can participate?
Patients with conditions like rheumatoid arthritis or osteoarthritis of the knee and healthcare providers involved in such treatments will be eligible or interested.
Conclusion
The Persona Solution PPS Femur PMCF study represents a step forward in the validation of knee arthroplasty solutions under real-world conditions. Regulatory teams, clinicians, and device specialists should monitor the study closely as details unfold.
Disclaimer
This content is intended for informational purposes only. It does not constitute legal or clinical advice. Please consult official sources or qualified professionals for specific guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07286513?term=medical+device