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

Study acronym: CORI RCT TKA
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 11, 2026 (before its estimated April 17, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jul 31, 2025 to Apr 17, 2026
    • Study completion date: May 15, 2027 to Mar 31, 2028
    v8
  2. Primary completion date: Aug 31, 2026 to Jul 31, 2025
    • Study completion date: Oct 30, 2026 to May 15, 2027
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Site details revised at 1 of 4 sitesv5
  5. Primary completion date: Dec 30, 2025 to Aug 31, 2026
    • Study completion date: Dec 30, 2025 to Oct 30, 2026
    • Eligibility criteria expanded, about 55 words
    • Site details revised at 2 of 4 sites
    v4
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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Aug 30, 2022 to Dec 30, 2025
    • Study completion date: Jul 30, 2024 to Dec 30, 2025
    • Start date changed from estimate of Jan 30, 2022 to Feb 12, 2022
    • Site details revised at 4 of 4 sites
  2. Start date: Apr 30, 2021 to Jan 30, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04848896
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Arthroplasty, Replacement, Knee
Related terms Osteoarthritis
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov