Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Ar… (NCT04797897) | Clinical Trial Compass
TerminatedNot Applicable
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
Stopped: The Study terminated prematurely due to very low patient enrollment in the study.
Australia, Hong Kong, New Zealand4 participantsStarted 2022-02-12
Plain-language summary
This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is a suitable candidate for a UKA procedure using CORI and a compatible S+N Knee implant system.
. Subject requires a cemented UKA as a primary indication that meets any of the following conditions:
. Non-inflammatory degenerative joint disease, including osteoarthritis
. Avascular necrosis
. Requires correction of functional deformity
. Requires treatment of fractures that were unmanageable using other techniques
. Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethics Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
Exclusion criteria
. Subject receives a UKA on the index joint as a revision for a previously failed surgery, or need for complex implants, or any other implant than a standard UKA (e.g. stems, augments, or custom made devices).
. Subject has been diagnosed with post-traumatic arthritis
. Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA.
. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:-Contralateral primary TKA or UKA, however, the subject can only have one knee enrolled in this study.
. Subject does not understand the language used in the Informed Consent Form.
. Subject does not meet the indication or is contraindicated for UKA according to specific S+N knee system's Instructions For Use (IFU).
. Subject has active infection or sepsis (treated or untreated).
. Subject is morbidly obese with a body mass index (BMI) greater than 40.