Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC)

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 (PFGG) in children with spastic cerebral palsy (CP) and hips at risk of dislocation (HRD). Hip dislocation is a common and severe complication in children with CP, especially those who are non-ambulatory, with a reported risk of 70-90%. The trial includes children aged 3 to 8 years with spastic CP and HRD, defined by a migration percentage (MP) between 30% and 60%. Participants will be cluster-randomized by center into two parallel groups: * Experimental Group: Standard prophylactic treatment for HRD + PFGG * Control Group: Standard prophylactic treatment for HRD only PFGG involves insertion of a fully threaded cannulated screw across the lateral cortex and proximal femoral epiphysis under fluoroscopic guidance, with the aim of modulating growth to improve hip containment. All patients will also receive standard soft tissue surgery (adductor and/or psoas tenotomies), as clinically indicated. Follow-up will include clinical, radiographic, and functional assessments at 3 and 6 weeks, and at 6, 12, 18, and 24 months post-intervention. The study will include a 1-year inclusion period and a 2-year follow-up, concluding in October 2027. Primary outcome measures include radiographic indicators of hip displacement. Secondary outcomes include functional scores, complication rates, and need for further surgery. A total of 42 participants (21 per group) will provide 80% power to detect significant differences at a 0.05 significance level. Analyses will be performed using intention-to-treat principles, with subgroup and multivariate analyses to explore modifying factors.

NCT Number	NCT06956729
Lead Sponsor	Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús Collaborators: Hospital Sant Joan de Deu, Salamanca University Hospital, Complexo Hospitalario Universitario de A Coruña, Hospital General Universitario Gregorio Marañon, Hospital Universitario de Canarias, Hospital Universitario Central de Asturias, Hospital Son Espases, Hospital Universitario 12 de Octubre, Hospital Vall d'Hebron, Hospital Universitario Virgen Macarena, Hospital Miguel Servet, Hospital Donostia, Hospitales Universitarios Virgen del Rocío, Complejo Hospitalario de Navarra, Hospital Universitario Ramon y Cajal, Hospital Universitario Torrecárdenas
Conditions	Cerebral Palsy
Enrollment	42 participants
Start Date	2024-10-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-04