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COMPLETED
NCT04338893
NA

ROSA Total Knee Post Market Study EMEA

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

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

Interventions

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

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