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

NARecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

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."

Trial Locations (16)

15009

RECRUITING

H. Materno Inf. Teresa Herrera, A Coruña

20014

RECRUITING

Donostia University Hospital, Donostia / San Sebastian

28007

RECRUITING

H. U. Gregorio Marañón, Madrid

28009

RECRUITING

Hospital Infantil Universitario Niño Jesús, Madrid

28034

RECRUITING

Hospital Universitario Ramón Y Cajal, Madrid

28041

RECRUITING

Hospital Universitario Doce de Octubre, Madrid

31008

RECRUITING

Complejo Hospitalario de Navarra, Pamplona

33011

RECRUITING

H.U. Central de Asturias, Oviedo

37007

RECRUITING

H. Universitario de Salamanca, Salamanca

38320

RECRUITING

H. Univ. de Canarias, Santa Cruz de Tenerife

41009

RECRUITING

H.U. Virgen Macarena Sevilla, Seville

41013

RECRUITING

H.U. Virgen Del Rocio, Seville

41014

RECRUITING

Ihp-Orthopediatica Sevilla, Seville

04009

RECRUITING

Hospital Universitario Torrecárdenas Almeria, Almería

07120

RECRUITING

H. Universitari Son Espases, Palma

08950

RECRUITING

H. Sant Joan de Deu, Barcelona

All Listed Sponsors
collaborator

Hospital Sant Joan de Deu

OTHER

collaborator

Salamanca University Hospital

OTHER

collaborator

Complexo Hospitalario Universitario de A Coruña

OTHER

collaborator

Hospital General Universitario Gregorio Marañon

OTHER

collaborator

Hospital Universitario de Canarias

OTHER

collaborator

Hospital Universitario Central de Asturias

OTHER

collaborator

Hospital Son Espases

OTHER

collaborator

Hospital Universitario 12 de Octubre

OTHER

collaborator

Hospital Vall d'Hebron

OTHER

collaborator

Hospital Universitario Virgen Macarena

OTHER

collaborator

Hospital Miguel Servet

OTHER

collaborator

Hospital Donostia

OTHER

collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

collaborator

Complejo Hospitalario de Navarra

OTHER

collaborator

Hospital Universitario Ramon y Cajal

OTHER

collaborator

Hospital Universitario Torrecárdenas

OTHER

lead

Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús

OTHER