NCT04338893Completed
ROSA Total Knee Post Market Study EMEA
ROSA Total Knee Post Market Study: a Prospective, Multicenter EMEA Post Market Clinical Follow up of the ROSA Knee System
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 252 (actual)
- First submitted
- 24 Jan 2020
- Start date
- 15 Dec 2020
- Primary completion date
- 22 Aug 2025
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04338893
What you commit to
- Study type: Interventional
- Participants enrolled: 252
- From 15 Dec 2020 to the primary completion date, 22 Aug 2025
- 6 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Patient has previously received partial or total knee arthroplasty for the ipsilateral knee
Other
- 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.)
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Hôpitaux universitaires de Genève Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Herzogin Elisabeth Hospital Coordinator of this site? Confirm its status | Braunschweig | Germany | Unknown status |
| Evangelisches Waldkrankenhaus Spandau Coordinator of this site? Confirm its status | Spandau | Germany | Unknown status |
| The Research Fund of Hadassah Medical Organization Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| San Giuseppe Hospital Coordinator of this site? Confirm its status | Arezzo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.