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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04848896
Registration number
NCT04848896
Ethics application status
Date submitted
7/04/2021
Date registered
19/04/2021
Titles & IDs
Public title
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
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Scientific title
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
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Secondary ID [1]
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CORI.2020.08
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Universal Trial Number (UTN)
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Trial acronym
CORI RCT TKA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthroplasty
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Replacement
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Knee
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - CORI Robotics
Treatment: Surgery - Conventional Procedure
Experimental: CORI - Subjects in need for total knee arthroplasty (TKA) as decided by their doctor and treated with CORI Robotics System.
Active comparator: Conventional Procedure - Subjects in need for total knee arthroplasty (TKA) as decided by their doctor and treated with conventional approach with conventional manual instrumentation.
Treatment: Devices: CORI Robotics
Total knee arthroplasty (TKA) treated with CORI Robotics System.
Treatment: Surgery: Conventional Procedure
Total knee arthroplasty (TKA) 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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Intervention code [2]
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Treatment: Surgery
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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 and 24 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 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.
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Timepoint [3]
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Pre-op, 6 weeks, 6 months, 12 months and 24 months
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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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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.
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Timepoint [4]
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Pre-op, 6 weeks, 6 months, 12 months and 24 months
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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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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.
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Timepoint [5]
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6 weeks, 6 months, 12 months and 24 months
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Secondary outcome [6]
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EuroQol Five-Dimensional Five-Level (EQ-5D-5L)
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Assessment method [6]
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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.
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Timepoint [6]
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Pre-op, 6 weeks, 6 months, 12 months and 24 months
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Eligibility
Key inclusion criteria
1. Subject is a suitable candidate for a TKA procedure using CORI and a corresponding S+N Knee Implant System.
2. Subject requires a cemented TKA as a primary indication that meets any of the following condition:
* Non-inflammatory degenerative joint disease, including osteoarthritis
* Rheumatoid arthritis
* Avascular necrosis
* Requires correction of functional deformity
* 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 Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form.
5. Subject plans to be available through two (2) year postoperative follow-up.
6. Applicable routine radiographic assessment is 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 requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (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 TKA according to the specific Smith+Nephew 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 TKA 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 International Organization for Standardization (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
NA
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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
30/10/2026
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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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China
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State/province [1]
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Beijing
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Country [2]
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Hong Kong
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State/province [2]
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Sha Tin
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Country [3]
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New Zealand
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State/province [3]
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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
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.
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Trial website
https://clinicaltrials.gov/study/NCT04848896
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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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Jack Cramer
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Address
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Country
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Phone
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+61 460 727 771
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04848896