Phase
Condition
Orthopedics
Treatment
CORI Robotics
Conventional Procedure
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is a suitable candidate for a TKA procedure using CORI and a correspondingS+N Knee Implant System.
Subject requires a cemented TKA as a primary indication that meets any of thefollowing 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 ofage at the time of surgery)
Subject agrees to consent to and to follow the study visit schedule (as defined inthe 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
Exclusion Criteria:
Subject requires a TKA on the index joint as a revision for a previously failedsurgery, or has the need for complex implants, or any other implant than a standardTKA (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 contralateralTKA.
Subject has one or more of the following arthroplasties that are not fully healedand well-functioning, as determined by the investigator:-Contralateral primary TKAor 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 thespecific 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 jointdisease 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 neuromusculardisease, or an active, local infection).
Subject in the opinion of the Investigator has an emotional or neurologicalcondition that would pre-empt their ability or willingness to participate in thestudy including mental illness, intellectual disability, drug or alcohol abuse.
Subject, in the opinion of the Investigator, has a neuromuscular disorder thatprohibited control of the index joint.
Subject is a prisoner or meets the definition of a Vulnerable Subject perInternational Organization for Standardization (ISO) 14155:2020 Section 3.55.
Study Design
Connect with a study center
Northern Hospital
Epping, 3076
AustraliaActive - Recruiting
Jishuitan Hospital, Beijing
Beijing, 100035
ChinaActive - Recruiting
The Prince of Wales Hospital
Sha Tin,
Hong KongActive - Recruiting
North Shore Hospital
Auckland, 0620
New ZealandActive - Recruiting
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