GUIDed Growth of the Proximal Femur to Prevent Further Hip migrAtion iN CErebral Palsy Patients

Cerebral Palsy Clinical Trial

— GUIDANCE  

Official title:

GUIDed Growth of the Proximal Femur to Prevent Further Hip migrAtion iN CErebral Palsy Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118736
• Other study ID #: PanamaID 10082
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hip Dislocation

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