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

Last updated: October 7, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

Temporary Medial Hemi-epiphysiodesis of the proximal femur

Clinical Study ID

NCT06118736
PanamaID 10082
  • Ages 2-8
  • All Genders

Study 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 Criteria

Inclusion

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

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 anacetabular index > 30 degrees, consistent with A2 and A3 acetabular deformityaccording to Robin and Graham in an adequately performed radiographs

Study Design

Total Participants: 84
Treatment Group(s): 1
Primary Treatment: Temporary Medial Hemi-epiphysiodesis of the proximal femur
Phase:
Study Start date:
March 06, 2024
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Site Not Available

  • UMC Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Maastricht UMC

    Maastricht,
    Netherlands

    Active - Recruiting

  • Sint Maartenskliniek

    Nijmegen,
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam,
    Netherlands

    Active - Recruiting

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