Actively Recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE12122 CORI12122 System in Total Knee Arthroplasty Procedure
Led by Smith & Nephew, Inc. · Updated on 2026-03-11
140
Participants Needed
4
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the REAL INTELLIGENCE12122 CORI12122 robotic system in total knee arthroplasty (TKA) procedures. The study aims to compare the CORI system with conventional manual surgical methods to see how well they achieve correct leg alignment after surgery. This research will support the registration of the CORI system in mainland China and involves 140 participants across several countries. Participants will be randomly assigned to one of two groups: one receiving TKA surgery using the CORI Robotics System and the other receiving TKA using conventional manual instruments. Each participant will undergo a cemented TKA procedure with either the CORI system or the conventional approach as decided by their surgeon. The study is conducted at up to eight sites globally, including Australia, China, Hong Kong, and New Zealand. Participants will be followed for up to two years after surgery with assessments including post-operative leg alignment at 6 weeks, component alignment, and radiographic evaluations at 12 and 24 months. Knee function and quality of life will be measured using various scores before surgery and at multiple points after surgery. This includes the Knee Society Score, Oxford Knee Score, Forgotten Joint Score, and EuroQol Five-Dimensional Five-Level questionnaire. The study monitors safety and effectiveness through these clinical and radiographic assessments.
CONDITIONS
Brief 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...
- Subject is a suitable candidate for TKA using CORI and a corresponding Smith & Nephew Knee Implant System.
- Subject requires a cemented total knee arthroplasty for conditions such as osteoarthritis, rheumatoid arthritis, avascular necrosis, functional deformity correction, or fracture treatment.
- Subject is at least 18 years old and skeletally mature.
- Subject agrees to give informed consent and follow the study visit schedule.
- Subject plans to be available for two years of post-operative follow-up.
- Subject can undergo routine radiographic assessments.
You will not qualify if you...
- Subject needs TKA revision surgery, complex implants, or non-standard devices.
- Subject has post-traumatic arthritis.
- Subject receives simultaneous bilateral unicondylar knee arthroplasty or unilateral UKA with contralateral TKA.
- Subject has unhealed or poorly functioning arthroplasties on the other knee.
- Subject does not understand the language of the consent form.
- Subject does not meet TKA indications or has contraindications per the Smith & Nephew Knee System instructions.
- Subject has active infection or sepsis.
- Subject has a body mass index over 40.
- Subject is pregnant or breastfeeding at surgery time.
- Subject is better suited for an alternative procedure due to advanced joint disease.
- Subject is enrolled in another orthopedic clinical trial.
- Subject has conditions that may interfere with TKA outcome such as Paget's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency, neuromuscular disease, or local infection.
- Subject has emotional or neurological conditions affecting participation.
- Subject has neuromuscular disorder preventing control of the joint.
- Subject is a prisoner or classified as a vulnerable subject under ISO standards.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 2 weeks or until discharge
Participants undergo total knee arthroplasty (TKA) either with the CORI Robotics System or a conventional manual instrumentation procedure.
1 surgery visit and several immediate post-operative visits
Duration - 24 months
Participants attend follow-up visits to assess leg and component alignment, radiographic outcomes, and knee function scores over a two-year period.
Visits at 6 weeks, 6 months, 12 months, and 24 months
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
A
Alison Walker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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