NCT03969654

ROSA Robot Used in Total Knee Replacement Post Market Study

ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multicenter 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, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

Detailed 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 based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Conditions

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

Interventions

Type	Name	Description
DEVICE	PERSONA Total Knee	Primary Total Knee Arthroplasty
DEVICE	Vanguard Total Knee	Primary Total Knee Arthroplasty
DEVICE	NexGen Total Knee	Primary Total Knee Arthroplasty

Timeline

• Start date: 2020-05-01
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2019-05-31
• Last updated: 2024-05-03
• Results posted: 2024-05-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study