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ROSA Total Knee Post Market Study EMEA

CompletedNot applicableNCT04338893
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System
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
  • Procedure: Device: NexGen Total Knee
  • Procedure: Device: Vanguard Total Knee
Sponsor
Zimmer Biomet
Start date
2020-12-15
Primary completion
2025-08-22
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Belgium, Germany, Israel, Italy, Switzerland
Total sites listed
6

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion/Exclusion 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04338893