At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System
In Brief
A clinical study evaluating Device: Persona Total Knee, Device: NexGen Total Knee, and 1 other intervention for Knee Pain and 4 related conditions. Completed, enrolled 252 participants across 6 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice
The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice
The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice