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

Recruiting now · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID: NCT06956729
Run by: Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
People needed: 42
Starts: 2024-10-01
Expected to finish: 2027-12-31
Last updated by the study team: 2025-05-04

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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%.

You may not qualify if…

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 it is running

H. Materno Inf. Teresa Herrera — A Coruña, A Coruña, Spain (enrolling)
Hospital Universitario Torrecárdenas Almeria — Almería, Andalusia, Spain (enrolling)
H.U. Virgen Macarena Sevilla — Seville, Andalusia, Spain (enrolling)
H.U. Virgen Del Rocio — Seville, Andalusia, Spain (enrolling)
Ihp-Orthopediatica Sevilla — Seville, Andalusia, Spain (enrolling)
H. Universitari Son Espases — Palma, Balearic Islands, Spain (enrolling)
H. Universitario de Salamanca — Salamanca, Castille and León, Spain (enrolling)
H. Sant Joan de Deu — Barcelona, Catalonia, Spain (enrolling)
Donostia University Hospital — Donostia / San Sebastian, Gipuzkoa, Spain (enrolling)
H. U. Gregorio Marañón — Madrid, Madrid, Spain (enrolling)
Hospital Infantil Universitario Niño Jesús — Madrid, Madrid, Spain (enrolling)
Hospital Universitario Ramón Y Cajal — Madrid, Madrid, Spain (enrolling)
Hospital Universitario Doce de Octubre — Madrid, Madrid, Spain (enrolling)
Complejo Hospitalario de Navarra — Pamplona, Navarre, Spain (enrolling)
H.U. Central de Asturias — Oviedo, Principality of Asturias, Spain (enrolling)
H. Univ. de Canarias — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.