NCT06956729: GGSH-MC

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

Recruiting now NA Last updated 4 May 2025

What this trial tests

NA trial testing Proximal Femoral Guided Growth. in Cerebral Palsy in 42 participants. Currently enrolling.

Timeline

1 October 2024

Primary endpoint
31 December 2025

31 December 2027

Quick facts

Lead sponsor	Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	1 October 2024
Primary completion	31 December 2025
Estimated completion	31 December 2027
Sites	16 locations across Spain

Drugs / interventions tested

• Proximal Femoral Guided Growth.
• Standard prophylactic treatment for Hips at Risk of Dislocation.

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús

Who can join

Adults 3 to 8, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.