NCT03970629

ROSA Total Knee Investigational Testing Authorization Study

ROSA Total Knee Investigational Testing Authorization Study: Prospective Single Center Study of the ROSA Total Knee System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, single-center clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.

Detailed 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 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.

Conditions

• Knee Pain
• Chronic Osteoarthritis
• Avascular Necrosis of Femoral Condyle
• Moderate Varus, Valgus or Flexion Deformities
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	PERSONA Total Knee	Primary Total Knee Arthroplasty

Timeline

• Start date: 2019-06-20
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2019-05-31
• Last updated: 2022-05-19

Locations

1 site across 1 country: Canada