Guided growth treatment for hip dislocation risk in children with cerebral palsy
Guided Growth in Spastic Hip - Multicenter Study (GGSH-MC)
This study is testing a new growth treatment for children with cerebral palsy to see if it can help keep their hips stable and improve their overall movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús Academic / other |
| Locations | 16 sites (A Coruña, A Coruña and 15 other locations) |
| Trial ID | NCT06956729 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial evaluates the effectiveness of Proximal Femoral Guided Growth (PFGG) in children aged 3 to 8 years with spastic cerebral palsy and hips at risk of dislocation. Participants will be randomly assigned to receive either standard prophylactic treatment plus PFGG or standard treatment alone. The study aims to assess mid-term outcomes related to hip containment and overall function. PFGG is a minimally invasive procedure that seeks to improve hip stability by modulating growth through a cannulated screw insertion.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 8 years with spastic cerebral palsy and hips at risk of dislocation, defined by a migration percentage between 30% and 60%.
Not a fit: Patients with predominantly hypotonic or dystonic types of cerebral palsy or those who have had previous hip surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of hip dislocation and improve quality of life for children with cerebral palsy.
How similar studies have performed: While early outcomes of PFGG are promising, this multicenter trial aims to provide more robust evidence, as similar approaches have shown limited prospective data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
A Coruña, A Coruña and 15 other locations
- H. Materno Inf. Teresa Herrera — A Coruña, A Coruña, Spain (Recruiting)
- Hospital Universitario Torrecárdenas Almeria — Almería, Andalusia, Spain (Recruiting)
- H.U. Virgen Macarena Sevilla — Seville, Andalusia, Spain (Recruiting)
- H.U. Virgen Del Rocio — Seville, Andalusia, Spain (Recruiting)
- Ihp-Orthopediatica Sevilla — Seville, Andalusia, Spain (Recruiting)
- H. Universitari Son Espases — Palma, Balearic Islands, Spain (Recruiting)
- H. Universitario de Salamanca — Salamanca, Castille and León, Spain (Recruiting)
- H. Sant Joan de Deu — Barcelona, Catalonia, Spain (Recruiting)
- Donostia University Hospital — Donostia / San Sebastian, Gipuzkoa, Spain (Recruiting)
- H. U. Gregorio Marañón — Madrid, Madrid, Spain (Recruiting)
- Hospital Infantil Universitario Niño Jesús — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Ramón Y Cajal — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Doce de Octubre — Madrid, Madrid, Spain (Recruiting)
- Complejo Hospitalario de Navarra — Pamplona, Navarre, Spain (Recruiting)
- H.U. Central de Asturias — Oviedo, Principality of Asturias, Spain (Recruiting)
- H. Univ. de Canarias — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (Recruiting)
Study contacts
- Principal investigator: María Galán Olleros, MD — Hospital Infantil Universitario Niño Jesús, Madrid
- Study coordinator: María Galán Olleros, M.D
- Email: mgalanolleros@gmail.com
- Phone: 0034660492192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.