Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC)
Launched by FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉTICA HOSPITAL INFANTIL UNIVERSITARIO NIÑO JESÚS · May 1, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The Guided Growth in Spastic Hip Multicenter Study (GGSH-MC) is a clinical trial aimed at helping children with cerebral palsy (CP) who are at risk of having their hips dislocate. This trial focuses on children aged 3 to 8 years with spastic CP and hips that have a specific measure of risk. Participants will be divided into two groups: one will receive a standard treatment plus a new growth-modulating procedure called Proximal Femoral Guided Growth (PFGG), while the other will only receive the standard treatment. The goal is to see if adding PFGG helps improve their hip stability over time.
If your child qualifies for the trial, they will undergo some assessments at various points over the next two years to track their progress and any potential complications. This study will help researchers understand the effectiveness of PFGG in preventing hip dislocation in children with CP. To be eligible, your child should be between 3 and 8 years old with a diagnosis of spastic CP and hips that meet specific criteria. Children with other types of CP or certain medical conditions may not be eligible. Overall, this trial aims to find better ways to support children with CP and enhance their quality of life.
Gender
ALL
Eligibility 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.
About Fundación Para La Investigación Biomética Hospital Infantil Universitario Niño Jesús
The Fundación para la Investigación Biomédica del Hospital Infantil Universitario Niño Jesús is a leading institution dedicated to advancing pediatric healthcare through innovative research and clinical trials. Committed to enhancing the understanding and treatment of childhood diseases, the foundation fosters collaboration among healthcare professionals, researchers, and academic institutions. By focusing on cutting-edge biomedical research, the foundation aims to translate scientific discoveries into effective therapies, ultimately improving health outcomes for children. Its robust infrastructure and expertise make it a pivotal player in the realm of pediatric clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Pamplona, Navarra, Spain
Madrid, , Spain
Madrid, , Spain
Sevilla, , Spain
Almería, Andalucía, Spain
Sevilla, Andalucía, Spain
Sevilla, Andalucía, Spain
Sevilla, Andalucía, Spain
Salamanca, Castilla Y Leon, Spain
Barcelona, Cataluña, Spain
Donostia, Gipuzkoa, Spain
Palma, Illes Balears, Spain
Oviedo, , Spain
Santa Cruz De Tenerife,, Santa Cruz De Tenerife, Spain
A Coruña, , Spain
Madrid, , Spain
Almería, , Spain
Sevilla, , Spain
Sevilla, , Spain
Barcelona, , Spain
Oviedo, Principado De Asturias, Spain
Patients applied
Trial Officials
María Galán Olleros, MD
Principal Investigator
Hospital Infantil Universitario Niño Jesús, Madrid
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported