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RECRUITING
NCT04848896
NA

Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

Sponsor: Smith & Nephew, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

CORI Robotics

Total knee arthroplasty (TKA) treated with CORI Robotics System.

PROCEDURE

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