RecruitingNot ApplicableNCT06118736

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


Sponsor

Erasmus Medical Center

Enrollment

84 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 YearsMax Age: 8 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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

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Interventions

PROCEDURETemporary Medial Hemi-epiphysiodesis of the proximal femur

Temporary Medial Hemi-epiphysiodesis of the proximal femur


Locations(5)

Amsterdam UMC

Amsterdam, Netherlands

UMC Groningen

Groningen, Netherlands

Maastricht UMC

Maastricht, Netherlands

Sint Maartenskliniek

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

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NCT06118736


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