CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 126 enrolled
Drug / intervention
CORI Roboticsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04786119
NCT04786119N/ACompleted

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

Smith & Nephew, Inc.·interventional·Posted Mar 8, 2021·Updated Oct 31, 2025

In Brief

A clinical study evaluating CORI Robotics for Arthroplasty and 2 related conditions. Completed, enrolled 126 participants across 8 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, India, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 8, 2021
Enrollment StartFeb 17, 2021
Primary CompletionOct 27, 2023
Study CompletionSep 10, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.3 years ago

Interventions

CORI Roboticsdevice

Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.