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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    140
  • sponsor
    Smith & Nephew, Inc.
Updated on 17 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. 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:

140 research participants will be recruited from up to 6 sites in 4 countries globally (UK, US, Germany and India). There will be 70 patients having UKA surgery and 70 patients having TKA surgery.

Details
Condition Arthroplasty, Replacement, Knee
Treatment CORI Robotics
Clinical Study IdentifierNCT04786119
SponsorSmith & Nephew, Inc.
Last Modified on17 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject's treating clinician has decided that REAL INTELLIGENCE™ CORI™ and a compatible Smith+Nephew Knee Implant System is the best treatment for the subject's unicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subject has agreed to the treatment
Subject requires a cemented UKA or TKA as a primary indication that meets either criterion A or B
A. Subject requires a cemented UKA as a primary indication due to any of the following conditions
Non-inflammatory degenerative joint disease, including osteoarthritis
Avascular necrosis
Requires correction of functional deformity
Requires treatment of fractures that were unmanageable using other techniques
B. Subject requires a cemented TKA as a primary indication due to any of the
Degenerative joint disease, including osteoarthritis
following condition
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
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
at the time of surgery)
Subject plans to be available through one (1) year postoperative follow-up
Routine radiographic assessment is possible

Exclusion Criteria

Subject receives a CORI Robotics UKA or TKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard 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 according to 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 or UKA 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, mental retardation, 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 ISO 14155:2011 Section 3.44
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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