ROSA Total Knee Investigational Testing Authorization Study

Rheumatoid Arthritis Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03970629
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Terminated
• Phase: N/A
• Start date: June 20, 2019
• Completion date: November 23, 2021