RecruitingNot ApplicableNCT04848896

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

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


Sponsor

Smith & Nephew, Inc.

Enrollment

140 participants

Start Date

Feb 12, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CORI Robotics and Conventional Procedure for people with knee, replacement, and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECORI Robotics

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

PROCEDUREConventional 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

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NCT04848896


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