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Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Sponsor: Smith & Nephew, Inc.
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 in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.
Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2022-02-12
Completion Date
2028-03-31
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
CORI Robotics
Total knee arthroplasty (TKA) treated with CORI Robotics System.
Conventional Procedure
Total knee arthroplasty (TKA) treated with conventional approach with conventional manual instrumentation.
Locations (4)
Northern Hospital
Epping, Australia
Jishuitan Hospital, Beijing
Beijing, China
The Prince of Wales Hospital
Shatin, Hong Kong
North Shore Hospital
Auckland, New Zealand