NCT04461626

Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,017 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)

Timeline

• Start date: 2014-11-19
• Primary completion: 2023-06-30
• Completion: 2024-08-21
• First posted: 2020-07-08
• Last updated: 2024-08-22

Locations

18 sites across 6 countries: Australia, India, Japan, New Zealand, Singapore, South Korea