Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System. 2. Subject requires a cemented TKA as a primary indication that meets any of the following condition: * Non-inflammatory degenerative joint disease, including osteoarthritis * Rheumatoid arthritis * Avascular necrosis * Requires correction of functional deformity * Requires treatment of fractures that were unmanageable using other techniques 3. Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery) 4. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form. 5. Subject plans to be available through two (2) year postoperative follow-up. 6. Applicable routine radiographic assessment is possible. Exclusion Criteria: 1. Subject req