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GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients (GUIDANCE)

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Erasmus University

Status

Enrolling

Conditions

Hip Dislocation
Cerebral Palsy

Treatments

Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur

Study type

Interventional

Funder types

Other

Identifiers

NCT06118736
PanamaID 10082

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

2 to 8 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Adductor tenotomy + Temporary Medial Hemi-epiphysiodesis of the proximal femur
Experimental group
Description:
Standard care + intervention
Treatment:
Procedure: Temporary Medial Hemi-epiphysiodesis of the proximal femur
Adductor tenotomy
No Intervention group
Description:
Standard care

Trial contacts and locations

5

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Central trial contact

Jaap Tolk, MD PhD; Merel Roelen, MD

Data sourced from clinicaltrials.gov

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