GUIDed Growth of the Proximal Femur to Prevent Further Hip MigrAtion in CErebral Palsy Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-8
SponsorErasmus Medical Center
About this trial
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
Qualifiers
Spastic CP
GMFCS level IV-V
Aged 2-8 years
At least one hip with an abduction in flexion ≤ 40 degrees
Disqualifiers
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
Treatments tested in this trial
- Temporary Medial Hemi-epiphysiodesis of the proximal femur
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov