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

Study Overview
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Brief Summary
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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 certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics. The data collected will be used to meet the post-market clinical follow-up requirement in Europe and to support claims and publications. Objectives: The primary objective of this study is to evaluate the use of CORI Robotics in UKA and TKA procedures in achieving post-operative leg alignment to check that the results of the operation are similar to what the surgeon originally planned. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 4 countries globally (UK, US, Germany and India). There will be 70 patients having UKA surgery and 70 patients having TKA surgery.

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

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: CORI Robotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject's treating clinician has decided that REAL INTELLIGENCE™ CORI™ and a compatible Smith+Nephew Knee Implant System is the best treatment for the subject's unicondylar knee arthroplasty (UKA) or total knee arthroplasty (TKA) and the subject has agreed to the treatment. Subject requires a cemented UKA or TKA as a primary indication that meets either criterion A or B. A. Subject requires a cemented UKA as a primary indication due to 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 B. Subject requires a cemented TKA as a primary indication due to any of the following condition: 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 one (1) year postoperative follow-up. Routine radiographic assessment is possible. Subject able to follow instructions and deemed capable of completing all study questionnaires. Exclusion Criteria: Subject receives a CORI Robotics UKA or TKA 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 or TKA (e.g. stems, augments, or custom made devices). Subject has been diagnosed with post-traumatic arthritis Subject receives bilateral UKA or TKA Subject does not understand the language used in the Informed Consent Form. Subject does not meet the indication or is contraindicated for UKA or TKA according to 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 has a condition(s) that may interfere with the TKA or 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, mental retardation, 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 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CORI Robotics<br>Subjects having robotic assisted knee arthroplasty as decided by their doctor and treated with CORI Robotics. | Device: CORI Robotics<br>* Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.<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 - UKA | 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 in UKA subjects. | 6 weeks | 
| Component Alignment - TKA | 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 in TKA subjects | 6 weeks | 
| Radiographic assessment - UKA | Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis & implant migration in UKA subjects | 12 months | 
| Radiographic assessment - TKA | Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis & implant migration in TKA subjects | 12 months | 
| 2011 Knee Society Score (KSS) - UKA | The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in UKA subjects. The 2011 Knee Society Score consists of 4 separate sub-scales: (1) An Objective Knee Score (seven items: 100 points), (2) A Patient Satisfaction Score (five items: 40 points), (3) A Patient Expectation Score (three items: 15 points), and (4) A Functional Activity Score (19 items: 100 points). A higher number is a better outcome. | Pre-op, 6 week, 6 month and 12 months | 
| 2011 Knee Society Score (KSS) - TKA | The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities in TKA subjects. The 2011 Knee Society Score consists of 4 separate sub-scales: (1) An Objective Knee Score (seven items: 100 points), (2) A Patient Satisfaction Score (five items: 40 points), (3) A Patient Expectation Score (three items: 15 points), and (4) A Functional Activity Score (19 items: 100 points). A higher number is a better outcome. | Pre-op, 6 week, 6 month and 12 months | 
| Oxford Knee Score (OKS) - UKA | To specifically assess the patient's perspective of outcome following knee arthroplasty surgery in UKA subjects. 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. | Pre-op, 6 week, 6 month and 12 months | 
| Oxford Knee Score (OKS) - TKA | To specifically assess the patient's perspective of outcome following knee arthroplasty surgery in TKA subjects. 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. | Pre-op, 6 week, 6 month and 12 months | 
| Forgotten Joint Score (FJS) - UKA | To assess joint-specific patient reported outcomes in UKA subjects. Responses to 12 questions are recorded 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 and then reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. A score of 100 is the best possible outcome. | 6 week, 6 month and 12 months | 
| Forgotten Joint Score (FJS) - TKA | To assess joint-specific patient reported outcomes in TKA subjects. Responses to 12 questions are recorded 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 and then reversed with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living. A score of 100 is the best possible outcome. | 6 week, 6 month and 12 months | 
| Five-level EuroQol five-dimensional (EQ-5D-5L) VAS & index scores - UKA | To assess the subject's health state in UKA subjects. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome. | Pre-op, 6 week, 6 month and 12 months | 
| Five-level EuroQol five-dimensional (EQ-5D-5L) VAS & index scores - TKA | To assess the subject's health state in TKA subjects. The EQ-5D-5L is composed of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the five dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome. | Pre-op, 6 week, 6 month and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unicompartmental Knee Arthroplasty, Total Knee Arthroplasty