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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
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
Secondary ID [1] 0 0
CORI.2020.08
Universal Trial Number (UTN)
Trial acronym
CORI RCT TKA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthroplasty 0 0
Replacement 0 0
Knee 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post-operative Leg Alignment
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Component Alignment
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Radiographic Assessment
Timepoint [2] 0 0
12 months and 24 months
Secondary outcome [3] 0 0
2011 Knee Society Score (KSS)
Timepoint [3] 0 0
Pre-op, 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [4] 0 0
Oxford Knee Score (OKS)
Timepoint [4] 0 0
Pre-op, 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [5] 0 0
Forgotten Joint Score (FJS)
Timepoint [5] 0 0
6 weeks, 6 months, 12 months and 24 months
Secondary outcome [6] 0 0
EuroQol Five-Dimensional Five-Level (EQ-5D-5L)
Timepoint [6] 0 0
Pre-op, 6 weeks, 6 months, 12 months and 24 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Northern Hospital - Epping
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Sha Tin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julie Lankiewicz
Address 0 0
Smith & Nephew, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jack Cramer
Address 0 0
Country 0 0
Phone 0 0
+61 460 727 771
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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