ROSA Robot Used in Total Knee Replacement Post Market Study
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- 240
Summary
- Conditions
- Avascular Necrosis of the Femoral Condyle
- Chronic Osteoarthritis
- Knee Pain
- Moderate Varus, Valgus or Flexion Deformities
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety bas...
The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
Tracking Information
- NCT #
- NCT03969654
- Collaborators
- Not Provided
- Investigators
- Study Director: Kacy Arnold Zimmer Biomet
Get Well Soon