Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures

Study Overview
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Brief Summary
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This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.

Detailed Description
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This is a prospective, multi-center, randomized study to demonstrate the safety and effectiveness of CORI. In addition, the study will support regulatory approval by the National Medical Products Administration (NMPA) in China. The study will have two arms, the investigational group will be total knee arthroplasty (TKA) using CORI, the comparison group will be conventional approach with conventional manual instrumentation.

Official Title
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A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures

Conditions
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Non-inflammatory Degenerative Joint Disease, Including Osteoarthritis, Avascular Necrosis, Requires Correction of Functional Deformity, Requires Treatment of Fractures That Were Unmanageable Using Other Techniques

Intervention / Treatment
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* Device: CORI
* Device: Conventional


Participation Criteria
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Eligibility Criteria
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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. Subject plans to be available through one (1) year postoperative follow-up. Applicable routine radiographic assessment if possible. 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. 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 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). 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 ISO 14155:2020 Section 3.55.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CORI UKA<br>Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI. | Device: CORI<br>* unicondylar knee arthroplasty (UKA) treated with CORI<br>|
| Active Comparator: Conventional UKA<br>Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation. | Device: Conventional<br>* unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative leg alignment | Post-operative leg alignment via radiographic assessment. Post-operative leg alignment is achieved when the deviation from the subject specific target does not exceed ±3 degrees. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Component Alignment | Component alignment will be assessed on long leg standing antero-posterior (A/P) X-rays and standard non weight bearing lateral X-rays taken 6 weeks after surgery | 6 weeks | 
| Radiographic assessment | Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis & implant migration. | 12 months | 
| 2011 Knee Society Score (KSS) | The Knee Society Score (KSS) is a validated tool combining objective physician-derived component with a subjective subject-derived component consisting of 36 questions & provides sub-scores across 4 dimensions. The Objective Knee Score rated by clinician assesses UKA alignment, stability, Range of Motion (ROM) and symptoms. The Subject Satisfaction Score assesses 5 daily activities: sitting, lying in bed, getting out of bed, light household duties, & leisure activities). The Subject Expectation Score evaluates the subject's expectations prior to surgery. Post-operative questions differ from pre-operative questions and ask if the subject's pre-operative expectations were met. Pre-op & post-op scores because they are based on different questions. The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities. | from pre-operative visit up to 12 months post-surgery | 
| Oxford Knee Score (OKS) | The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to assess perceived function and pain answered on a Likert scale after Total Knee Arthroplasty. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome. | from pre-operative visit up to 12 months post-surgery | 
| Forgotten Joint Score (FJS) | The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. Subjects are asked to rate their awareness of their knee arthroplasty in 12 questions with a five point Likert response format: Never, almost never, seldom, sometimes and mostly. The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. | from operative visit up to 12 months post-surgery | 
| Five-level EuroQol five-dimensional (EQ-5D-5L) VAS and index scores | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The descriptive system is used to describe the subject's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. The visual analogue scale records the subject's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents. | from pre-operative visit up to 12 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis