NCT04730271

Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty

Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty: A Prospective, Non-Randomized Multi-Center Post-market Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual instrumentation. The VELYS Robotic-Assisted Solution helps the surgeon to plan bone cuts and then accurately achieve the planned cuts during the total knee replacement surgery. The study aims to compare how well the VELYS Robotic-Assisted system enables the surgeon to position the implants exactly as planned compared to manual instrumentation.

Conditions

• Osteo Arthritis Knee
• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Total Knee Replacement	Subjects will be implanted with an ATTUNE Primary total knee replacement.

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-04-07
• Completion: 2023-09-06
• First posted: 2021-01-29
• Last updated: 2025-04-27
• Results posted: 2024-07-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study