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Trial registered on ANZCTR
Registration number
ACTRN12625000604404
Ethics application status
Approved
Date submitted
27/05/2025
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Growing Screws in Slipped Capital Femoral Epiphysis (SCFE) (hip disorder where the growth plate of the femur bone slips out of place)
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Scientific title
Effect of Static Versus Free Gliding Screws on hip growth and function in Slipped Capital Femoral Epiphysis: A Randomised Controlled Trial
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Secondary ID [1]
314542
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Slipped capital femoral epiphysis
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Condition category
Condition code
Musculoskeletal
333969
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Free Gliding SCFE Screw System from Orthopediatrics (FG screw).
The study will compare the traditional treatment for mild-moderate stable SCFE which is a fully threaded cannulated screw (traditional screw) with the FG screw. This will be inserted as a surgical procedure into the proximal femoral epiphysis of the affected hip and sometimes as a prophylactic measure dependent on individual patient risk. This will be inserted in a single setting under general anaesthesia shortly after patient presentation to a secondary/tertiary hospital. The screw that the patient is randomised to will be inserted by an orthopaedic surgeon trained in the usage of both the traditional and FG screws. The screw takes approximately 1-2 hours to insert in a single surgical procedure.
The FG screw has a telescopic design with 'medial and lateral threaded fixations, connected through a trilobe self-extending shaft' as per Orthopediatrics. The screw is designed to provide stabilisation of the slipped growth plate whilst theoretically allowing continued growth of the hip. if the hip is allowed to continue to grow this should theoretically improve hip function and pain in the future.
The screw is placed with the intention of not being routinely removed unless there is a complication in the future e.g. osteonecrosis of the femoral head resulting in screw penetration of the hip joint, breakage of the screw causing pain and therefore necessitating removal of the screw, etc. The screw is not routinely removed because if the screw is removed prior to skeletal maturity there is the chance that the slip will recur.
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Intervention code [1]
331169
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Treatment: Surgery
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Intervention code [2]
331170
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Prevention
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Comparator / control treatment
The current gold standard treatment for mild-moderate, stable SCFE is a single fully threaded cannulated screw, therefore this will be used as our control to compare outcomes of the FG screw to current standard of treatment.
The standard screw also requires 1-2 hours to insert and similarly to the FG screw, there is no planned removal and will only be removed if required.
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Control group
Active
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Outcomes
Primary outcome [1]
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Articulotrochanteric distance
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Assessment method [1]
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Assessment of an anteroposterior pelvis radiograph and calculating the distance between the tip of the greater trochanter to the upper margin of the femoral head.
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Timepoint [1]
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Immediate post-operative day 1, week 6, month 3, month 6, month 12, year 2
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Secondary outcome [1]
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Screw lengthening
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Assessment method [1]
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Assessed on an anteroposterior pelvis radiograph by measuring the change in screw length over time compared to immediate post-operative x-rays
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Timepoint [1]
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Immediate post-operative day 1, week 6, month 3, month 6, month 12, year 2
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Secondary outcome [2]
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Centre-trochanteric distance
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Assessment method [2]
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The distance in millimetres between a perpendicular line drawn to the femoral shaft axis between two parallel lines that pass through the centre of the femoral head and the tip of the greater trochanter as measured on an AP radiograph
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Timepoint [2]
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Immediate post-operative day 1, month 3, month 6, month 12, year 2
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Secondary outcome [3]
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Alpha angle
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Assessment method [3]
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The angle measured from the centre of the femoral head between two points: the first point being a line parallel through the midline of the femoral neck, the second point being the point at which the distance from the centre of the femoral head is greater than the radius of the subchondral surface of the femoral head as measured on a lateral radiograph
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Timepoint [3]
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Immediate post-operative day 1, week 6, month 3, month 6, month 12, year 2
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Secondary outcome [4]
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Trendelenburg test
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Assessment method [4]
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Clinical Trendelenburg test to assess for hip abductor function
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Timepoint [4]
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All postoperative - Week 2, week 6, month 3, month 6, month 12, year 2
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Secondary outcome [5]
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Range of motion of hip
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Assessment method [5]
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By clinical examination
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Timepoint [5]
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All postoperative - Week 2, week 6, month 3, month 6, month 12, year 2
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Secondary outcome [6]
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Leg length discrepancy
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Assessment method [6]
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Clinical examination - using block test
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Timepoint [6]
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All postoperative - Week 2, week 6, month 3, month 6, month 12, year 2
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Secondary outcome [7]
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Patient reported outcome - hip function and pain
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Assessment method [7]
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Modified Harris Hip Score
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Timepoint [7]
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Pre-operative, postop month 3, month 6, month 12, month 24
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Secondary outcome [8]
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Patient reported outcome - activity tolerance
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Assessment method [8]
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UCLA Activity Score
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Timepoint [8]
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Pre-operative, postop month 3, month 6, month 12, month 24
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Secondary outcome [9]
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Patient reported outcome - pain
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Assessment method [9]
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Visual Analogue Scale for pain
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Timepoint [9]
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Pre-operative, postop month 3, month 6, month 12, month 24
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Secondary outcome [10]
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Patient reported outcome - pain, function, daily living
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Assessment method [10]
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HOOS JR Hip score
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Timepoint [10]
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Pre-operative, postop month 3, month 6, month 12, month 24
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Secondary outcome [11]
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Patient reported outcome - overall physical and mental health
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Assessment method [11]
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PROMIS-10
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Timepoint [11]
448609
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Pre-operative, postop month 3, month 6, month 12, month 24
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Eligibility
Key inclusion criteria
1. Skeletally immature patient with evidence of open proximal femoral physis on X-Ray AND at least 2 years of growth remaining (as determined by chronological age of 12 years and under for female patients and 14 years and under for male patients OR bone age of 12 years and under for female patients and 14 years and under for male patients)
2. Capacity to follow post-operative instructions (such as use of crutches/wheelchairs)
3. Mild to moderate slip OR prophylactic fixation, AND stable slip
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Minimum age
No limit
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Maximum age
15
Years
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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. Unstable slip
2. Severe slip
3. Triradiate cartilage completely fused
4. Secondary SCFE (identified underlying endocrine or other disorder affecting the hip)
5. Parent or guardian unable to provide informed consent
6. Unable to follow post-operative instructions
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Study design
Purpose of the study
Prevention
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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)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator using computer software
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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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
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2027
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Actual
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Date of last data collection
Anticipated
31/12/2029
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Te Whatu Ora Health New Zealand
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Address [1]
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Country [1]
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New Zealand
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Funding source category [2]
319091
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Charities/Societies/Foundations
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Name [2]
319091
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New Zealand Orthopaedic Association - Wishbone Foundation
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Address [2]
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Country [2]
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New Zealand
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Primary sponsor type
Hospital
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Name
Te Whatu Ora Health New Zealand
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321552
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Country [1]
321552
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317690
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
317690
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
317690
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New Zealand
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Date submitted for ethics approval [1]
317690
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11/01/2025
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Approval date [1]
317690
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24/04/2025
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Ethics approval number [1]
317690
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Summary
Brief summary
The purpose of this study is to determine whether the Growing Screw is a preferable or non-preferable screw compared to the traditional screw in the treatment of Slipped Capital Femoral Epiphysis. Patients will be randomly allocated to each group and will receive the screw through a single surgical procedure. They will then be closely followed-up and information about the two screws will be gathered and statistically compared to determine which is better for long term hip function and pain.
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Trial website
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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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Dr Andrew Kim
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Address
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Waikato Hospital - 183 Pembroke Street, Hamilton Lake, Hamilton 3204
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Country
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New Zealand
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Phone
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+64 212566204
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Fax
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Email
141822
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[email protected]
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Contact person for public queries
Name
141823
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Andrew Kim
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Address
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Waikato Hospital - 183 Pembroke Street, Hamilton Lake, Hamilton 3204
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Country
141823
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New Zealand
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Phone
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+64 212566204
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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
Name
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Andrew Kim
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Address
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Waikato Hospital - 183 Pembroke Street, Hamilton Lake, Hamilton 3204
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Country
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New Zealand
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Phone
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+64 212566204
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
Letter-3.pdf
Study protocol
SCFE protocol 17_4_2025.docx.pdf
Informed consent form
SCFE - PISCF 1_4_2025.docx.pdf
Informed consent form
SCFE - Assent Form 5-9 2_4_2025.docx.pdf
Informed consent form
SCFE - Assent Form 2_4_2025.docx.pdf
Informed consent form
SCFE - Ongoing informed consent PISCF 2_4_2025.docx.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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