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

Last updated: January 15, 2025
Sponsor: Smith & Nephew, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedics

Treatment

CORI Robotics

Conventional Procedure

Clinical Study ID

NCT04848896
CORI.2020.08
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Subject is a suitable candidate for a TKA procedure using CORI and a correspondingS+N Knee Implant System.

  2. Subject requires a cemented TKA as a primary indication that meets any of thefollowing 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

  1. Subject is of legal age to consent and considered skeletally mature (≥ 18 years ofage at the time of surgery)

  2. Subject agrees to consent to and to follow the study visit schedule (as defined inthe study protocol and informed consent form), by signing the Ethical Committee (EC)or Institutional Review Board (IRB) approved informed consent form.

  3. Subject plans to be available through two (2) year postoperative follow-up.

  4. Applicable routine radiographic assessment is possible.

Exclusion

Exclusion Criteria:

  1. Subject requires a TKA on the index joint as a revision for a previously failedsurgery, or has the need for complex implants, or any other implant than a standardTKA (e.g. stems, augments, or custom-made devices).

  2. Subject has been diagnosed with post-traumatic arthritis.

  3. Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateralTKA.

  4. Subject has one or more of the following arthroplasties that are not fully healedand well-functioning, as determined by the investigator:-Contralateral primary TKAor UKA, however, the subject can only have one knee enrolled in this study.

  5. Subject does not understand the language used in the Informed Consent Form.

  6. Subject does not meet the indication or is contraindicated for TKA according to thespecific Smith+Nephew Knee System's Instructions For Use (IFU).

  7. Subject has active infection or sepsis (treated or untreated).

  8. Subject is morbidly obese with a body mass index (BMI) greater than 40.

  9. Subject is pregnant or breast feeding at the time of surgery.

  10. Subject, in the opinion of the Investigator, has advanced osteoarthritis or jointdisease at the time of surgery and was better suited for an alternate procedure.

  11. Subject currently enrolled in another orthopedic clinical trial study.

  12. 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 neuromusculardisease, or an active, local infection).

  13. Subject in the opinion of the Investigator has an emotional or neurologicalcondition that would pre-empt their ability or willingness to participate in thestudy including mental illness, intellectual disability, drug or alcohol abuse.

  14. Subject, in the opinion of the Investigator, has a neuromuscular disorder thatprohibited control of the index joint.

  15. Subject is a prisoner or meets the definition of a Vulnerable Subject perInternational Organization for Standardization (ISO) 14155:2020 Section 3.55.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: CORI Robotics
Phase:
Study Start date:
February 12, 2022
Estimated Completion Date:
May 15, 2027

Connect with a study center

  • Northern Hospital

    Epping, 3076
    Australia

    Active - Recruiting

  • Jishuitan Hospital, Beijing

    Beijing, 100035
    China

    Active - Recruiting

  • The Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Active - Recruiting

  • North Shore Hospital

    Auckland, 0620
    New Zealand

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.