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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04797897
Registration number
NCT04797897
Ethics application status
Date submitted
12/03/2021
Date registered
15/03/2021
Date last updated
7/02/2024
Titles & IDs
Public title
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
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Scientific title
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
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Secondary ID [1]
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CORI.2019.06
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Universal Trial Number (UTN)
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Trial acronym
CORI RCT UKA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-inflammatory Degenerative Joint Disease, Including Osteoarthritis
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Avascular Necrosis
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Requires Correction of Functional Deformity
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Requires Treatment of Fractures That Were Unmanageable Using Other Techniques
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Musculoskeletal
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Other muscular and skeletal disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - CORI
Treatment: Devices - Conventional
Experimental: CORI UKA - Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with CORI.
Active Comparator: Conventional UKA - Subjects in need for unicondylar knee arthroplasty (UKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Treatment: Devices: CORI
unicondylar knee arthroplasty (UKA) treated with CORI
Treatment: Devices: Conventional
unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Post-operative leg alignment
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Assessment method [1]
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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.
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Timepoint [1]
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6 weeks
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Secondary outcome [1]
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Component Alignment
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Assessment method [1]
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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
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Timepoint [1]
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6 weeks
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Secondary outcome [2]
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Radiographic assessment
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Assessment method [2]
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Radiographic assessment on antero-posterior (A/P) and lateral (L) views shall be performed to identify the presence of radiolucent lines, osteolysis & implant migration.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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2011 Knee Society Score (KSS)
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Assessment method [3]
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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.
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Timepoint [3]
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from pre-operative visit up to 12 months post-surgery
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Secondary outcome [4]
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Oxford Knee Score (OKS)
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Assessment method [4]
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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.
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Timepoint [4]
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from pre-operative visit up to 12 months post-surgery
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Secondary outcome [5]
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Forgotten Joint Score (FJS)
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Assessment method [5]
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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.
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Timepoint [5]
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from operative visit up to 12 months post-surgery
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Secondary outcome [6]
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Five-level EuroQol five-dimensional (EQ-5D-5L) VAS and index scores
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Assessment method [6]
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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.
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Timepoint [6]
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from pre-operative visit up to 12 months post surgery
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Eligibility
Key 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:
1. Non-inflammatory degenerative joint disease, including osteoarthritis
2. Avascular necrosis
3. Requires correction of functional deformity
4. 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 if possible.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 this 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/01/2027
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Northern Hospital - Epping
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Recruitment postcode(s) [1]
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3076 - Epping
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Sha Tin
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a prospective study to demonstrate the safety and effectiveness of CORI and to
register CORI in China mainland.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04797897
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Julie Lankiewicz
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Address
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Smith & Nephew, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Manvendra Saxena, PhD
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Address
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Country
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Phone
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+61 455 870 175
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04797897
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