None listed
Conditions
Sponsors
Smith & Nephew
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Subject is a suitable candidate for a UKA procedure using CORI and a compatible S+N Knee Implant System. 2 Subject requires a cemented UKA as a primary indication that meets any of the following conditions: a) Non-inflammatory degenerative joint disease, including osteoarthritis b) Avascular necrosis c) Requires correction of functional deformity d) Requires treatment of fractures that were unmanageable using other techniques 3 Subject is of legal age to consent and considered skeletally mature (= 18 years of age at the time of surgery) 4 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. 5 Subject plans to be available through one (1) year postoperative follow-up. 6 Applicable routine radiographic assessment is possible.
Exclusion criteria
Exclusion criteria: 1 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). 2 Subject has been diagnosed with post-traumatic arthritis 3 Subject receives simultaneous bilateral UKA OR a unilateral UKA with contralateral TKA. 4 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 the study. 5 Subject does not understand the language used in the Informed Consent Form. 6 Subject does not meet the indication or is contraindicated for UKA according to specific S+N knee system’s Instructions for Use (IFU). 7 Subject has active infection or sepsis (treated or untreated). 8 Subject is morbidly obese with a body mass index (BMI) greater than 40. 9 Subject is pregnant or breast feeding at the time of surgery. 10 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. 11 Subject currently enrolled in another orthopedic clinical trial study. 12 Subject has a condition(s) that may interfere with the UKA 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). 13 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. 14 Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint. 15 Subject is a prisoner or meets the definition of a Vulnerable Subject per ISO 14155:2020 Section 3.55.1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving post-operative leg alignment 6 weeks after surgery, defined as ± 3° from target as measured by radiographic assessment.;• Component alignment ;• Radiographic assessment (presence of radiolucent lines, osteolysis & implant migration); • 2011 Knee Society Score (2011 KSS) • Oxford Knee Score (OKS) • Forgotten Joint Score (FJS) • Five-level EuroQol five-dimensional (EQ-5D-5L) Visual Analogue Scale (VAS) and index scores | — |
Secondary
| Measure | Time frame |
|---|---|
| • Leg alignment pre- and post-cementation for CORI UKA • Navigations System time as extracted from the Subject’s CORI Case Report generated by the CORI Software. • Cutting time of the robotic drills extracted from the Subject’s CORI Case Report, generated by the CORI Software. | — |
Countries
Korea, Republic of
Contacts
Public ContactYong Deok Kim
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Outcome results
None listed