NCT04338893

ROSA Total Knee Post Market Study EMEA

ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main purpose of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation. This will be achieved by assessing: planned vs actual component positioning, operative workflow efficiency, patient safety based on incidence and frequency of adverse events, clinical performance measured by overall pain and function, health-related quality of life data and radiographic parameters. The primary endpoint will report on the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional and the secondary endpoints will record surgery time points and evaluate the change of clinical outcomes scores between baseline and post operative follow up for performance and clinical benefits

Conditions

• Knee Pain
• Chronic Osteoarthritis
• Avascular Necrosis of the Femoral Condyle
• Moderate Varus, Valgus or Flexion Deformities
• Rheumatoid Arthritis

Interventions

Type	Name	Description
PROCEDURE	Device: Persona Total Knee	The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice
PROCEDURE	Device: NexGen Total Knee	The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice
PROCEDURE	Device: Vanguard Total Knee	The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice

Timeline

• Start date: 2020-12-15
• Primary completion: 2025-08-22
• Completion: 2025-08-22
• First posted: 2020-04-08
• Last updated: 2026-01-21
• Results posted: 2026-01-21

Locations

6 sites across 5 countries: Belgium, Germany, Israel, Italy, Switzerland