Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Knee Arthroplasty Procedures

Last updated: January 7, 2025
Sponsor: Smith & Nephew, Inc.
Overall Status: Completed

Phase

N/A

Condition

Orthopedics

Treatment

CORI Robotics

Clinical Study ID

NCT04786119
CORI.2019.07
  • 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. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications.

Objectives:

The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving post-operative leg alignment to check that the results of the operation are similar to what the surgeon originally planned.

Research participants / locations:

Research participants will be recruited from up to 8 sites in 4 countries globally (UK, US, Germany and India).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The subject's treating clinician has decided that REAL INTELLIGENCE™ CORI™ and acompatible Smith+Nephew Knee Implant System is the best treatment for the subject'sunicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subjecthas agreed to the treatment.

  • Subject requires a cemented UKA or TKA as a primary indication that meets eithercriterion A or B.

  • A. Subject requires a cemented UKA as a primary indication due to any of thefollowing conditions:

  1. Non-inflammatory degenerative joint disease, including osteoarthritis
  2. Avascular necrosis
  3. Requires correction of functional deformity
  4. Requires treatment of fractures that were unmanageable using othertechniques
  • B. Subject requires a cemented TKA as a primary indication due to any of thefollowing condition:
  1. Degenerative joint disease, including osteoarthritis
  2. Rheumatoid arthritis
  3. Avascular necrosis
  4. Requires correction of functional deformity
  5. Requires treatment of fractures that were unmanageable using othertechniques
  • Subject is of legal age to consent and considered skeletally mature (≥ 18 years ofage at the time of surgery)

  • 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.

  • Subject plans to be available through one (1) year postoperative follow-up.

  • Routine radiographic assessment is possible.

  • Subject able to follow instructions and deemed capable of completing all studyquestionnaires.

Exclusion

Exclusion Criteria:

  • Subject receives a CORI Robotics UKA or TKA on the index joint as a revision for apreviously failed surgery, or need for complex implants, or any other implant than astandard UKA or TKA (e.g. stems, augments, or custom made devices).

  • Subject has been diagnosed with post-traumatic arthritis

  • Subject receives bilateral UKA or TKA

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

  • Subject does not meet the indication or is contraindicated for UKA or TKA accordingto 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 jointdisease at the time of surgery and was better suited for an alternate procedure.

  • Subject has a condition(s) that may interfere with the TKA or UKA survival oroutcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscularatrophy, uncontrolled diabetes, moderate to severe renal insufficiency orneuromuscular disease, or an active, local infection).

  • 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, mental retardation, drug or alcohol abuse.

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

  • Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155Section 3.55.

Study Design

Total Participants: 126
Treatment Group(s): 1
Primary Treatment: CORI Robotics
Phase:
Study Start date:
February 17, 2021
Estimated Completion Date:
September 10, 2024

Connect with a study center

  • Orthopaedic clinic of the Medical School Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Pius-Hospital Oldenburg

    Oldenburg, 26121
    Germany

    Site Not Available

  • Lokmanya Hospital

    Pune, Maharashtra 411044
    India

    Site Not Available

  • The Royal Orthopaedic Hospital NHS Foundation Trust

    Birmingham, West Midlands B31 2AP
    United Kingdom

    Site Not Available

  • Orthopedic Institute of the West

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Duke Health

    Morrisville, North Carolina 27560
    United States

    Site Not Available

  • OrthoNeuro

    New Albany, Ohio 43054
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

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