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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06118736
Other study ID # PanamaID 10082
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date December 2030

Study information

Verified date October 2023
Source Erasmus Medical Center
Contact Merel Roelen, MD
Phone +31639173455
Email m.roelen@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date December 2030
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 2 Years to 8 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment failure Need for secondary bony hip surgery or progression of hip migration >50% 5 years follow up
Secondary 3-dimensional proximal femoral shape analysis varus/valgus and anteversion/retroversion at 2-year follow-up and at 5-year follow-up
Secondary CPChild questionnaire minimum value 0, maximum value 100, higher score means better outcome, " Caregivers Priorities and Child Health Index of Life with Disabilities" 5 year follow up
Secondary CPG questionnaire minimum value 0, maximum value 10, higher scores mean more pain, ' checklist pijngedrag' 5 year follow up
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