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 INTELLIGENCEâ„¢ CORIâ„¢ 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 range18 Years
SexALL
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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).
✓. 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.