Status:
RECRUITING
Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC)
Lead Sponsor:
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Collaborating Sponsors:
Hospital Sant Joan de Deu
Salamanca University Hospital
Conditions:
Cerebral Palsy
Eligibility:
All Genders
3-8 years
Phase:
NA
Brief Summary
The Guided Growth in Spastic Hip Multicenter Study (GGSH-MC) is a prospective, multicenter, randomized controlled trial that aims to evaluate the mid-term outcomes of Proximal Femoral Guided Growth (P...
Detailed Description
Cerebral palsy (CP) is the leading cause of severe physical disability in childhood, with a prevalence of 1.6 per 1,000 live births in developed countries. Spastic CP, affecting 75% of patients, often...
Eligibility Criteria
Inclusion
- Patients aged 3 to 8 years.
- Diagnosis of predominantly spastic cerebral palsy (CP).
- Any functional level according to the GMFCS.
- Hips at risk of dislocation (HRD), unilateral or bilateral, defined by a migration percentage (MP) between 30% and 60%.
Exclusion
- Children with predominantly hypotonic or dystonic types of CP.
- Children with neuromuscular conditions other than CP.
- Children with high surgical/anesthetic risk.
- Documented history of reconstructive or palliative hip surgery.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06956729
Start Date
October 1 2024
End Date
December 31 2027
Last Update
May 4 2025
Active Locations (16)
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1
H. Materno Inf. Teresa Herrera
A Coruña, A Coruña, Spain, 15009
2
Hospital Universitario Torrecárdenas Almeria
Almería, Andalusia, Spain, 04009
3
H.U. Virgen Macarena Sevilla
Seville, Andalusia, Spain, 41009
4
H.U. Virgen Del Rocio
Seville, Andalusia, Spain, 41013