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Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-02-12
Primary completion: 2026-11-30
Study completion finish: 2027-01-29
Study type
TREATMENT
Phase
NA
Trial ID
NCT04797897
Intervention or treatment
DEVICE: CORI
DEVICE: Conventional
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
Find a site
Closest Location:
Northern Hospital
Research sites nearby
Select from list below to view details:
Northern Hospital
Epping, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: CORI UKA
| DEVICE: CORI
|
ACTIVE_COMPARATOR: Conventional UKA
| DEVICE: Conventional
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 |
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