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

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.

Conditions

• Cerebral Palsy

Interventions

PROCEDURE

Proximal Femoral Guided Growth.

Proximal Femoral Guided Growth (PFGG) is performed under general anesthesia with the patient in a supine position on a radiolucent table. The surgical field is prepared from the abdomen to the feet. Anatomical landmarks on the femur and femoral neck are marked to guide the procedure. A smooth guidewire (4.0-7.0 mm) is introduced parallel to the table and advanced to the lateral quarter of the femoral neck. A 1-2 cm incision is made along the lateral femur, allowing access to the vastus lateralis muscle. Fluoroscopic control is used to ensure precise guidewire placement in the proximal femoral epiphysis in both anteroposterior (AP) and lateral views. The lateral cortex is drilled, and a fully threaded cannulated screw is inserted, ensuring at least three threads reach the epiphysis for effective growth modulation. Final fluoroscopic verification is performed to confirm proper screw placement and rule out joint penetration. Continuous fluoroscopy is used if necessary. The guidewire is r

PROCEDURE

Standard prophylactic treatment for Hips at Risk of Dislocation.

Both groups will receive standard prophylactic treatment for HRD, which consists of soft tissue release procedures based on clinical indication and functional level (GMFCS classification): Adductor Tenotomy - Percutaneous or open technique, depending on contracture severity. Psoas Tenotomy - Intrapelvic approach for GMFCS levels I-III and IV (ambulatory). Lesser trochanter approach for GMFCS levels IV-V (non-ambulatory). Additional tenotomies may be performed as needed, targeting muscles contributing to hip displacement and contractures. Botulinum toxin type A may be administered to specific muscle groups if clinically indicated. Postoperative immobilization includes: Hip abduction wedge Knee immobilizers in extension Ankle-foot orthoses (AFOs), based on individual patient needs The goal of this intervention is to reduce spastic muscle imbalance, improve hip stability, and delay or prevent hip dislocation in children with spastic CP and HRD.

Sponsors & Collaborators

• Hospital Sant Joan de Deu

  collaborator OTHER

• Salamanca University Hospital

  collaborator OTHER

• Complexo Hospitalario Universitario de A Coruña

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Hospital Universitario de Canarias

  collaborator OTHER

• Hospital Universitario Central de Asturias

  collaborator OTHER

• Hospital Son Espases

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• Hospital Miguel Servet

  collaborator OTHER

• Hospital Donostia

  collaborator OTHER

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• Complejo Hospitalario de Navarra

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Universitario Torrecárdenas

  collaborator OTHER

• Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús

  lead OTHER

Principal Investigators

• María Galán Olleros, MD · Hospital Infantil Universitario Niño Jesús, Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2025-12-31

Completion

2027-12-31

Countries

• Spain

Study Locations