Global CORI Cohort Study UKA & TKA
Research type
Research Study
Full title
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
IRAS ID
284404
Contact name
Edward Davis
Contact email
Sponsor organisation
Smith + Nephew Orthapaedics AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 29 days
Research 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.
Secondary objectives are to generate safety and performance data supporting the use of CORI Robotics procedures.
Other objectives are to collect Robotics System time and cutting time of the robotic drill from the CORI Robotics Case Report.
Research participants / locations:
140 research participants will be recruited from 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.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0049
Date of REC Opinion
18 Mar 2021
REC opinion
Further Information Favourable Opinion