Status:
COMPLETED
ROSA Total Knee Post Market Study EMEA
Lead Sponsor:
Zimmer Biomet
Conditions:
Knee Pain
Chronic Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2025
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT04338893
Start Date
December 15 2020
End Date
August 22 2025
Last Update
September 17 2025
Active Locations (6)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium
2
Herzogin Elisabeth Hospital
Braunschweig, Germany
3
Evangelisches Waldkrankenhaus Spandau
Spandau, Germany
4
The Research Fund of Hadassah Medical Organization
Jerusalem, Israel