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ROSA Total Knee Post Market Study EMEA

NCT04338893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2026-05-12

Study results available
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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.

Conditions

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

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

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Emilie Rohmer · Zimmer Biomet

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2025-08-22
Completion
2025-08-22

Countries

  • Belgium
  • Germany
  • Israel
  • Italy
  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338893 on ClinicalTrials.gov