Actively Recruiting
Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC)
Led by Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús · Updated on 2025-05-04
42
Participants Needed
16
Research Sites
169 weeks
Total Duration
On this page
Sponsors
F
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Lead Sponsor
H
Hospital Sant Joan de Deu
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Trial of Proximal Femoral Guided Growth in Children With CP and Hips at Risk of Dislocation (GGSH-MC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 3 to 8 years
- Diagnosis of predominantly spastic cerebral palsy
- Any functional level according to the Gross Motor Function Classification System (GMFCS)
- Hips at risk of dislocation with migration percentage between 30% and 60%
You will not qualify if you...
- Predominantly hypotonic or dystonic cerebral palsy
- Neuromuscular conditions other than cerebral palsy
- High surgical or anesthetic risk
- History of reconstructive or palliative hip surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
H. Materno Inf. Teresa Herrera
A Coruña, A Coruña, Spain, 15009
Actively Recruiting
2
Hospital Universitario Torrecárdenas Almeria
Almería, Andalusia, Spain, 04009
Actively Recruiting
3
H.U. Virgen Macarena Sevilla
Seville, Andalusia, Spain, 41009
Actively Recruiting
4
H.U. Virgen Del Rocio
Seville, Andalusia, Spain, 41013
Actively Recruiting
5
Ihp-Orthopediatica Sevilla
Seville, Andalusia, Spain, 41014
Actively Recruiting
6
H. Universitari Son Espases
Palma, Balearic Islands, Spain, 07120
Actively Recruiting
7
H. Universitario de Salamanca
Salamanca, Castille and León, Spain, 37007
Actively Recruiting
8
H. Sant Joan de Deu
Barcelona, Catalonia, Spain, 08950
Actively Recruiting
9
Donostia University Hospital
Donostia / San Sebastian, Gipuzkoa, Spain, 20014
Actively Recruiting
10
H. U. Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
11
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Spain, 28009
Actively Recruiting
12
Hospital Universitario Ramón Y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
13
Hospital Universitario Doce de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
14
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
15
H.U. Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
16
H. Univ. de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38320
Actively Recruiting
Research Team
M
María Galán Olleros, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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