Actively Recruiting

Phase Not Applicable
Age: 3Years - 8Years
All Genders
NCT06956729

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

Age: 3Years - 8Years
All Genders

Eligibility Criteria

Eligible

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%
Not Eligible

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

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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

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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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