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Growing Screws in Slipped Capital Femoral Epiphysis (SCFE) (hip disorder where the growth plate of the femur bone slips out of place)

Effect of Static Versus Free Gliding Screws on hip growth and function in Slipped Capital Femoral Epiphysis: A Randomised Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000604404
Enrollment
50
Registered
2025-06-12
Start date
2025-07-01
Completion date
2027-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 pre

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.

Sponsors

Te Whatu Ora Health New Zealand
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
No minimum to 15 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026