Actively Recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Led by Smith & Nephew, Inc. · Updated on 2026-03-11
140
Participants Needed
4
Research Sites
319 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suitable candidate for a total knee arthroplasty (TKA) using CORI and a Smith+Nephew Knee Implant System
- Requires a primary cemented TKA for conditions such as osteoarthritis, rheumatoid arthritis, avascular necrosis, functional deformity correction, or treatment of unmanageable fractures
- At least 18 years old and skeletally mature at the time of surgery
- Willing to provide informed consent and follow the study visit schedule
- Plans to be available for two years of postoperative follow-up
- Able to undergo routine radiographic assessments
You will not qualify if you...
- Requires revision TKA or complex implants other than standard TKA
- Diagnosed with post-traumatic arthritis
- Receiving simultaneous bilateral unicondylar knee arthroplasty (UKA) or unilateral UKA with contralateral TKA
- Has unhealed or poorly functioning arthroplasties on the opposite knee
- Does not understand the language of the informed consent form
- Does not meet the specific indications or has contraindications for TKA according to the Smith+Nephew Knee System instructions
- Has active infection or sepsis
- Morbidly obese with BMI greater than 40
- Pregnant or breastfeeding at time of surgery
- Has advanced osteoarthritis or joint disease better treated by another procedure
- Currently enrolled in another orthopedic clinical trial
- Has conditions that may interfere with TKA survival or outcomes, such as Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency, neuromuscular disease, or active local infection
- Has emotional, neurological, or mental conditions that affect ability or willingness to participate
- Has neuromuscular disorder preventing control of the index joint
- Is a prisoner or classified as a Vulnerable Subject per ISO 14155:2020 Section 3.55
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Northern Hospital
Epping, Australia, 3076
Actively Recruiting
2
Jishuitan Hospital, Beijing
Beijing, China, 100035
Actively Recruiting
3
The Prince of Wales Hospital
Shatin, Hong Kong
Actively Recruiting
4
North Shore Hospital
Auckland, New Zealand, 0620
Actively Recruiting
Research Team
J
Jack Cramer
CONTACT
A
Alison Walker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here