Trial Review

ANZCTR is currently experiencing a technical issue. Thank you for your patience while we work on it and apologies for any inconvenience caused.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
Scientific title
Effect of Static Versus Free Gliding Screws on hip growth and function in Slipped Capital Femoral Epiphysis: A Randomised Controlled Trial
Secondary ID [1] 314542 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Slipped capital femoral epiphysis 337643 0
Condition category
Condition code
Musculoskeletal 333969 333969 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 331169 0
Treatment: Surgery
Intervention code [2] 331170 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 341626 0
Articulotrochanteric distance
Timepoint [1] 341626 0
Immediate post-operative day 1, week 6, month 3, month 6, month 12, year 2
Secondary outcome [1] 448127 0
Screw lengthening
Timepoint [1] 448127 0
Immediate post-operative day 1, week 6, month 3, month 6, month 12, year 2
Secondary outcome [2] 448128 0
Centre-trochanteric distance
Timepoint [2] 448128 0
Immediate post-operative day 1, month 3, month 6, month 12, year 2
Secondary outcome [3] 448129 0
Alpha angle
Timepoint [3] 448129 0
Immediate post-operative day 1, week 6, month 3, month 6, month 12, year 2
Secondary outcome [4] 448130 0
Trendelenburg test
Timepoint [4] 448130 0
All postoperative - Week 2, week 6, month 3, month 6, month 12, year 2
Secondary outcome [5] 448131 0
Range of motion of hip
Timepoint [5] 448131 0
All postoperative - Week 2, week 6, month 3, month 6, month 12, year 2
Secondary outcome [6] 448132 0
Leg length discrepancy
Timepoint [6] 448132 0
All postoperative - Week 2, week 6, month 3, month 6, month 12, year 2
Secondary outcome [7] 448133 0
Patient reported outcome - hip function and pain
Timepoint [7] 448133 0
Pre-operative, postop month 3, month 6, month 12, month 24
Secondary outcome [8] 448466 0
Patient reported outcome - activity tolerance
Timepoint [8] 448466 0
Pre-operative, postop month 3, month 6, month 12, month 24
Secondary outcome [9] 448467 0
Patient reported outcome - pain
Timepoint [9] 448467 0
Pre-operative, postop month 3, month 6, month 12, month 24
Secondary outcome [10] 448468 0
Patient reported outcome - pain, function, daily living
Timepoint [10] 448468 0
Pre-operative, postop month 3, month 6, month 12, month 24
Secondary outcome [11] 448609 0
Patient reported outcome - overall physical and mental health
Timepoint [11] 448609 0
Pre-operative, postop month 3, month 6, month 12, month 24

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

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319090 0
Hospital
Name [1] 319090 0
Te Whatu Ora Health New Zealand
Country [1] 319090 0
New Zealand
Funding source category [2] 319091 0
Charities/Societies/Foundations
Name [2] 319091 0
New Zealand Orthopaedic Association - Wishbone Foundation
Country [2] 319091 0
New Zealand
Primary sponsor type
Hospital
Name
Te Whatu Ora Health New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 321552 0
None
Name [1] 321552 0
Address [1] 321552 0
Country [1] 321552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317690 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317690 0
Ethics committee country [1] 317690 0
New Zealand
Date submitted for ethics approval [1] 317690 0
11/01/2025
Approval date [1] 317690 0
24/04/2025
Ethics approval number [1] 317690 0

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

Contacts
Principal investigator
Name 141822 0
Dr Andrew Kim
Address 141822 0
Waikato Hospital - 183 Pembroke Street, Hamilton Lake, Hamilton 3204
Country 141822 0
New Zealand
Phone 141822 0
+64 212566204
Fax 141822 0
Email 141822 0
[email protected]
Contact person for public queries
Name 141823 0
Andrew Kim
Address 141823 0
Waikato Hospital - 183 Pembroke Street, Hamilton Lake, Hamilton 3204
Country 141823 0
New Zealand
Phone 141823 0
+64 212566204
Fax 141823 0
Email 141823 0
[email protected]
Contact person for scientific queries
Name 141824 0
Andrew Kim
Address 141824 0
Waikato Hospital - 183 Pembroke Street, Hamilton Lake, Hamilton 3204
Country 141824 0
New Zealand
Phone 141824 0
+64 212566204
Fax 141824 0
Email 141824 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
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.