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

Status: Completed
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is a minimum of 18 years of age

• Independent of study participation, patient is a candidate for commercially available Persona, NexGen, or Vanguard knee components implanted in accordance with product labeling

• Patient has participated in this study-related Informed Consent Process

• Patient is willing and able to provide written Informed Consent by signing and dating the EC approved Informed Consent form

• Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Locations
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
Brussels
Germany
Herzogin Elisabeth Hospital
Braunschweig
Evangelisches Waldkrankenhaus Spandau
Spandau
Israel
The Research Fund of Hadassah Medical Organization
Jerusalem
Italy
San Giuseppe Hospital
Arezzo
Switzerland
Hôpitaux Universitaires de Genève
Geneva
Time Frame
Start Date: 2020-12-15
Completion Date: 2025-08-22
Participants
Target number of participants: 252
Treatments
Active_comparator: ROSA Total Knee Robotic Instrumentation
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
Active_comparator: Conventional TKA Instrumentation
Total knee arthroplasty performed with conventional instrumentation
Sponsors
Leads: Zimmer Biomet

This content was sourced from clinicaltrials.gov