GUIDed Growth of the Proximal Femur to Prevent Further Hip migrAtion iN CErebral Palsy Patients

Study Overview
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Brief Summary
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In recent literature, the potential of guided growth of the proximal femur to modify hip growth in patients with cerebral palsy has been shown. Using medial hemi-epiphysiodesis of the proximal femur (TMH-PF) morphology of hips at risk of symptomatic (sub)luxation in cerebral palsy (CP) can be changed, aiming to reduce further hip migration and the need for more invasive surgical treatment modalities. Further research is necessary to assess if the results of TMH-PF in combination with adductor tenotomies are significantly better than the results of the current standard of care; adductor tenotomies alone. The investigators objective is to determine whether guided growth of the proximal femur decreases the risk of further hip migration and need for further surgery in cerebral palsy patients.

Official Title
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GUIDed Growth of the Proximal Femur to Prevent Further Hip migrAtion iN CErebral Palsy Patients

Conditions
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Cerebral Palsy, Hip Dislocation

Intervention / Treatment
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* Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spastic CP GMFCS level IV-V Aged 2-8 years At least one hip with an abduction in flexion ≤ 40 degrees Migration percentage of 30-50% Head shaft angle > 145 Exclusion Criteria: Not fit for surgery History of bony hip surgery to the affected hip Severe acetabular dysplasia defined as a gothic arch, an incongruent joint or an acetabular index > 30 degrees, consistent with A2 and A3 acetabular deformity according to Robin and Graham in an adequately performed radiographs

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur<br>Standard care + intervention | Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur<br>* Temporary Medial Hemi-epiphysiodesis of the proximal femur<br>|
| No Intervention: Adductor tenotomy<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure | Need for secondary bony hip surgery or progression of hip migration >50% | 5 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-dimensional proximal femoral shape analysis | varus/valgus and anteversion/retroversion | at 2-year follow-up and at 5-year follow-up | 
| CPChild questionnaire | minimum value 0, maximum value 100, higher score means better outcome,  Caregivers Priorities and Child Health Index of Life with Disabilities | 5 year follow up | 
| CPG questionnaire | minimum value 0, maximum value 10, higher scores mean more pain, ' checklist pijngedrag' | 5 year follow up |