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ROSA Total Knee Post Market Study EMEA
Sponsor: Zimmer Biomet
Summary
This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data. This study might include Persona, Nexgen and Vanguard product families using the ROSA Total Knee Robotic system or conventional instrumentation. The primary objective is to evaluate the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation.
Official title: ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2020-12-15
Completion Date
2025-08-22
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Device: Persona Total Knee
The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice
Device: NexGen Total Knee
The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice
Device: Vanguard Total Knee
The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice
Locations (6)
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Herzogin Elisabeth Hospital
Braunschweig, Germany
Evangelisches Waldkrankenhaus Spandau
Spandau, Germany
The Research Fund of Hadassah Medical Organization
Jerusalem, Israel
San Giuseppe Hospital
Arezzo, Italy
Hôpitaux Universitaires de Genève
Geneva, Switzerland