NCT04786119

Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures

A Prospective, Multi-center, Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) and Total Knee Arthroplasty (TKA) Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications. Objectives: The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving post-operative leg alignment to check that the results of the operation are similar to what the surgeon originally planned. Research participants / locations: Research participants will be recruited from up to 8 sites in 4 countries globally (UK, US, Germany and India).

Conditions

• Arthroplasty
• Replacement
• Knee

Interventions

Type	Name	Description
DEVICE	CORI Robotics	Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.

Timeline

• Start date: 2021-02-17
• Primary completion: 2023-10-27
• Completion: 2024-09-10
• First posted: 2021-03-08
• Last updated: 2025-10-31
• Results posted: 2025-01-13

Locations

8 sites across 4 countries: United States, Germany, India, United Kingdom

Regulatory

• FDA-regulated device study