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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04797897




Registration number
NCT04797897
Ethics application status
Date submitted
12/03/2021
Date registered
15/03/2021

Titles & IDs
Public title
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
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
Secondary ID [1] 0 0
CORI.2019.06
Universal Trial Number (UTN)
Trial acronym
CORI RCT UKA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-inflammatory Degenerative Joint Disease 0 0
Osteoarthritis 0 0
Avascular Necrosis 0 0
Requires Correction of Functional Deformity 0 0
Fracture, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
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: Femoral Antero-Posterior (A/P) Angle
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Component Alignment: Tibial Antero-Posterior (A/P) Angle
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Component Alignment: Total Antero-Posterior (A/P) Valgus Angle
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Component Alignment: Lateral View Femoral Flexion Angle
Timepoint [4] 0 0
6 weeks
Secondary outcome [5] 0 0
Component Alignment: Lateral View Tibial Angle
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
Radiographic Assessment
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
2011 Knee Society Score (KSS): Objective Knee Score
Timepoint [7] 0 0
Baseline, 6 weeks, 6 months, and 12 months
Secondary outcome [8] 0 0
2011 Knee Society Score (KSS): Satisfaction Knee Score
Timepoint [8] 0 0
Baseline, 6 weeks, 6 months, and 12 months
Secondary outcome [9] 0 0
2011 Knee Society Score (KSS): Expectation Score
Timepoint [9] 0 0
Baseline, 6 weeks, 6 months, and 12 months
Secondary outcome [10] 0 0
2011 Knee Society Score (KSS): Functional Score
Timepoint [10] 0 0
Baseline, 6 weeks, 6 months, and 12 months
Secondary outcome [11] 0 0
Oxford Knee Score (OKS)
Timepoint [11] 0 0
Baseline, 6 weeks, 6 months, and 12 months
Secondary outcome [12] 0 0
Forgotten Joint Score (FJS)
Timepoint [12] 0 0
6 weeks, 6 months, and 12 months
Secondary outcome [13] 0 0
Five-level EuroQol Five-dimensional (EQ-5D-5L): Index Score
Timepoint [13] 0 0
Baseline, 6 weeks, 6 months, and 12 months
Secondary outcome [14] 0 0
Five-level EuroQol Five-dimensional (EQ-5D-5L): Visal Analogue Scale (VAS) Score
Timepoint [14] 0 0
Baseline, 6 weeks, 6 months, and 12 months

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

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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
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
Actual
16/02/2024
Sample size
Target
Accrual to date
Final
4
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
Hong Kong
State/province [1] 0 0
Sha Tin
Country [2] 0 0
New Zealand
State/province [2] 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
Patricia McCracken
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
Manvendra Saxena, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 455 870 175
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04797897