Guided Growth in Spastic Hip - Multicenter Study (GGSH-MC)

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 8
Healthy Volunteers: f
View:

• 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%.

Locations
Other Locations
Spain
H. Materno Inf. Teresa Herrera
RECRUITING
A Coruña
Hospital Universitario Torrecárdenas Almeria
RECRUITING
Almería
H. Sant Joan de Deu
RECRUITING
Barcelona
Donostia University Hospital
RECRUITING
Donostia / San Sebastian
H. U. Gregorio Marañón
RECRUITING
Madrid
Hospital Infantil Universitario Niño Jesús
RECRUITING
Madrid
Hospital Universitario Doce de Octubre
RECRUITING
Madrid
Hospital Universitario Ramón Y Cajal
RECRUITING
Madrid
H.U. Central de Asturias
RECRUITING
Oviedo
H. Universitari Son Espases
RECRUITING
Palma
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
H. Universitario de Salamanca
RECRUITING
Salamanca
H. Univ. de Canarias
RECRUITING
Santa Cruz De Tenerife
H.U. Virgen Del Rocio
RECRUITING
Seville
H.U. Virgen Macarena Sevilla
RECRUITING
Seville
Ihp-Orthopediatica Sevilla
RECRUITING
Seville
Contact Information
Primary
María Galán Olleros, M.D
mgalanolleros@gmail.com
0034660492192
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 42
Treatments
Experimental: PFGG + Standard Treatment (Experimental Group A)
Participants in this arm will receive Proximal Femoral Guided Growth (PFGG) in addition to standard prophylactic treatment for hips at risk of dislocation (HRD).~The standard treatment may include adductor tenotomy (percutaneous or open) and psoas tenotomy (intrapelvic or at the lesser trochanter) as indicated.~Surgery will be performed under general anesthesia, and postoperative immobilization will follow institutional protocols, including the use of a hip abduction wedge, knee immobilizers, and ankle-foot orthoses (AFO) as required.~Follow-up will include standardized clinical, functional, and radiographic assessments at 3 weeks, 6 weeks, 6 months, 12 months, 18 months, and 24 months postoperatively.
Active_comparator: Standard Treatment Only (Control Group B)
Participants in this arm will receive standard prophylactic treatment for HRD without PFGG.~This may include adductor and/or psoas tenotomies based on clinical indication, performed under general anesthesia.~Postoperative care will be identical to the experimental group, with standard immobilization using a hip abduction wedge, knee immobilizers, and AFOs as needed.~The follow-up schedule and outcome assessments will be identical to the experimental group, ensuring consistency in data collection.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Universitario 12 de Octubre, Hospital Miguel Servet, Hospital Vall d'Hebron, Hospital Son Espases, Hospital Donostia, Complexo Hospitalario Universitario de A Coruña, Hospitales Universitarios Virgen del Rocío, Hospital Universitario Torrecárdenas, Hospital Universitario Central de Asturias, Hospital Universitario de Canarias, Hospital General Universitario Gregorio Marañon, Complejo Hospitalario de Navarra, Salamanca University Hospital, Hospital Sant Joan de Deu, Hospital Universitario Ramon y Cajal, Hospital Universitario Virgen Macarena
Leads: Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús

This content was sourced from clinicaltrials.gov