ROSA Total Knee Investigational Testing Authorization Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Avascular Necrosis of 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 70 years
- Gender
- Both males and females
Description
The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty. The assessments will include: Planned vs actual component positioning; Workflow eff...
The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty. The assessments will include: Planned vs actual component positioning; Workflow efficiency; Patient safety based on incidence and frequency of adverse events; Clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
Tracking Information
- NCT #
- NCT03970629
- Collaborators
- Not Provided
- Investigators
- Study Director: Kacy Arnold Zimmer Biomet
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