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NCT04848896: CORI RCT TKA

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

Recruiting now NA Last updated 11 March 2026
What this trial tests

NA trial testing CORI Robotics in Arthroplasty in 140 participants. Currently enrolling.

Timeline
12 February 2022
Primary endpoint
17 April 2026
31 March 2028

Quick facts

Lead sponsorSmith & Nephew, Inc.
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment140
Start date12 February 2022
Primary completion17 April 2026
Estimated completion31 March 2028
Sites4 locations across China, Hong Kong, New Zealand, Australia

Drugs / interventions tested

Conditions studied

Sponsor

Smith & Nephew, Inc. — full company profile →

Who can join

18 and older, any sex, with Arthroplasty or Replacement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of CORI Robotics

Trials testing the same drug.

Other recruiting trials for Arthroplasty

Currently open trials in the same condition.

Other Smith & Nephew, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04848896.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing