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

RECRUITINGNA

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

A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

NCT04848896•Smith & Nephew, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
•2. Subject requires a cemented TKA as a primary indication that meets any of the following 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
•3. Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery)
•4. 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.
•5. Subject plans to be available through two (2) year postoperative follow-up.
+1 more criteria

Exclusion Criteria

•1. 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).
•2. Subject has been diagnosed with post-traumatic arthritis.
•3. Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
•4. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or 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 the specific 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 joint disease at the time of surgery and was better suited for an alternate procedure.
+5 more criteria

Locations (4)

Northern Hospital

Epping, Australia

Jishuitan Hospital, Beijing

Beijing, China

The Prince of Wales Hospital

Shatin, Hong Kong

North Shore Hospital

Auckland, New Zealand

Key Dates

Start Date

February 12, 2022

Primary Completion Date

April 17, 2026

Completion Date

March 31, 2028

Last Updated

March 11, 2026

Enrollment

140

ESTIMATED participants

Conditions

ArthroplastyReplacementKnee

Interventions

CORI Robotics

DEVICE

Conventional Procedure

PROCEDURE

Contacts

Jack Cramer

CONTACT

+61 460 727 771 Jack.Cramer@Smith-Nephew.com

Alison Walker

CONTACT

+61 466 322 200 Alison.Walker@Smith-Nephew.Com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

To Compare Post-Extraction Use of a Novel Ethylenediaminetetraacetic Acid (EDTA) Post-operative Mouth Rinse and Daily Use EDTA Mouth Rinse and Standard 0.12% Chlorhexidine (CHX) Post-operative Mouth Rinse and Daily Use Essential Oil (EO) Mouth Rinse.

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