Clinical Trials in the Netherlands / NCT06118736
Recruiting Not applicable

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

NCT06118736 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2024-03-06
Last updated
2024-10-08

Condition(s) studied

Cerebral PalsyHip Dislocation

Investigational drug(s) / intervention(s)

Temporary Medial Hemi-epiphysiodesis of the proximal femur

Temporary Medial Hemi-epiphysiodesis of the proximal femur: Temporary Medial Hemi-epiphysiodesis of the proximal femur

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

Sex
ALL
Min age
2 Years
Max age
8 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam Netherlands Not Yet Recruiting
UMC Groningen Groningen Netherlands Recruiting
Maastricht UMC Maastricht Netherlands Recruiting
Sint Maartenskliniek Nijmegen Netherlands Not Yet Recruiting
Erasmus MC Rotterdam Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06118736 on ClinicalTrials.gov ↗ ← All trials in the Netherlands