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 in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Total knee arthroplasty (TKA) treated with CORI Robotics System.
Total knee arthroplasty (TKA) treated with conventional approach with conventional manual instrumentation.
Northern Hospital
Epping, Australia
RECRUITINGJishuitan Hospital, Beijing
Beijing, China
RECRUITINGThe Prince of Wales Hospital
Shatin, Hong Kong
RECRUITINGNorth Shore Hospital
Auckland, New Zealand
RECRUITINGPost-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.
Time frame: 6 weeks
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
Time frame: 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.
Time frame: 12 months and 24 months
2011 Knee Society Score (KSS)
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 subscales: 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) 4. A Functional Activity Score (19 items: 100 points). A higher number is a better outcome.
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Oxford Knee Score (OKS)
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.
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
Forgotten Joint Score (FJS)
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.
Time frame: 6 weeks, 6 months, 12 months and 24 months
EuroQol Five-Dimensional Five-Level (EQ-5D-5L)
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 ranging from 'the best health you can imagine' to 'the worst health you can imagine'. A higher number is a better outcome.
Time frame: Pre-op, 6 weeks, 6 months, 12 months and 24 months
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