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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    140
  • sponsor
    Smith & Nephew, Inc.
Updated on 26 May 2022

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.

Details
Condition Arthroplasty, Replacement, Knee
Treatment Conventional procedure, CORI Robotics
Clinical Study IdentifierNCT04848896
SponsorSmith & Nephew, Inc.
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System
Subject requires a cemented TKA as a primary indication that meets any of the following condition
Degenerative joint disease, including osteoarthritis
Rheumatoid arthritis
Avascular necrosis
Requires correction of functional deformity
Requires treatment of fractures that were unmanageable using other techniques
Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age
at the time of surgery)
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
Subject plans to be available through two (2) year postoperative follow-up
Applicable routine radiographic assessment is possible

Exclusion Criteria

Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom-made devices)
Subject has been diagnosed with post-traumatic arthritis
Subject requires bilateral TKA
Subject does not understand the language used in the Informed Consent Form
Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU)
Subject has active infection or sepsis (treated or untreated)
Subject is morbidly obese with a body mass index (BMI) greater than 40
Subject is pregnant or breast feeding at the time of surgery
Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure
Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection)
Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse
Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint
Subject is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2011 Section 3.44
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