Status:
RECRUITING
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Arthroplasty
Replacement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ce...
Eligibility Criteria
Inclusion
- Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
- Subject requires a cemented TKA as a primary indication that meets any of the following condition:
- Non-inflammatory degenerative joint disease, including osteoarthritis
- Rheumatoid arthritis
- 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 Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
- Subject plans to be available through two (2) year postoperative follow-up.
- Applicable routine radiographic assessment is possible.
Exclusion
- Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (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 TKA according to the specific Smith+Nephew 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.
- Subject is pregnant or breast feeding at the time of surgery.
- Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure.
- Subject currently enrolled in another orthopedic clinical trial study.
- Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection).
- Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.
- Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint.
- Subject is a prisoner or meets the definition of a Vulnerable Subject per International Organization for Standardization (ISO) 14155:2020 Section 3.55.
Key Trial Info
Start Date :
February 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04848896
Start Date
February 12 2022
End Date
May 15 2027
Last Update
January 17 2025
Active Locations (4)
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1
Northern Hospital
Epping, Australia, 3076
2
Jishuitan Hospital, Beijing
Beijing, China, 100035
3
The Prince of Wales Hospital
Shatin, Hong Kong
4
North Shore Hospital
Auckland, New Zealand, 0620