ROSA Total Knee Post Market Study EMEA

NCT ID: NCT04338893

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2025-08-22

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ROSA Total Knee Robotic Instrumentation

Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation

Group Type: ACTIVE_COMPARATOR

Device: Persona Total Knee

Intervention Type: PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice

Device: NexGen Total Knee

Intervention Type: PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice

Device: Vanguard Total Knee

Intervention Type: PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice

Conventional TKA Instrumentation

Total knee arthroplasty performed with conventional instrumentation

Group Type: ACTIVE_COMPARATOR

Device: Persona Total Knee

Intervention Type: PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice

Device: NexGen Total Knee

Intervention Type: PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice

Device: Vanguard Total Knee

Intervention Type: PROCEDURE

The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice

Interventions

Device: Persona Total Knee

The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice

Intervention Type: PROCEDURE

Device: NexGen Total Knee

The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice

Intervention Type: PROCEDURE

Device: Vanguard Total Knee

The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patient is currently participating in any other surgical intervention studies or pain management studies
• Patient has underwent contralateral UKA or TKA within the last 18 months
• Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
• Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation)
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Rohmer

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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

Countries

Belgium; Germany; Israel; Italy; Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CME2019-24K

Identifier Type: -

Identifier Source: org_study_id