Condition: Cerebral Palsy · Sponsor: Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
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 …
This description comes directly from the study's public registry record.
María Galán Olleros, M.D · 0034660492192 · mgalanolleros@gmail.com
Always discuss trial participation with your own doctor first.
| 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 |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06956729