42
Participants
Start Date
October 1, 2024
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2027
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"
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."
RECRUITING
H. Materno Inf. Teresa Herrera, A Coruña
RECRUITING
Donostia University Hospital, Donostia / San Sebastian
RECRUITING
H. U. Gregorio Marañón, Madrid
RECRUITING
Hospital Infantil Universitario Niño Jesús, Madrid
RECRUITING
Hospital Universitario Ramón Y Cajal, Madrid
RECRUITING
Hospital Universitario Doce de Octubre, Madrid
RECRUITING
Complejo Hospitalario de Navarra, Pamplona
RECRUITING
H.U. Central de Asturias, Oviedo
RECRUITING
H. Universitario de Salamanca, Salamanca
RECRUITING
H. Univ. de Canarias, Santa Cruz de Tenerife
RECRUITING
H.U. Virgen Macarena Sevilla, Seville
RECRUITING
H.U. Virgen Del Rocio, Seville
RECRUITING
Ihp-Orthopediatica Sevilla, Seville
RECRUITING
Hospital Universitario Torrecárdenas Almeria, Almería
RECRUITING
H. Universitari Son Espases, Palma
RECRUITING
H. Sant Joan de Deu, Barcelona
Hospital Sant Joan de Deu
OTHER
Salamanca University Hospital
OTHER
Complexo Hospitalario Universitario de A Coruña
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Universitario de Canarias
OTHER
Hospital Universitario Central de Asturias
OTHER
Hospital Son Espases
OTHER
Hospital Universitario 12 de Octubre
OTHER
Hospital Vall d'Hebron
OTHER
Hospital Universitario Virgen Macarena
OTHER
Hospital Miguel Servet
OTHER
Hospital Donostia
OTHER
Hospitales Universitarios Virgen del Rocío
OTHER
Complejo Hospitalario de Navarra
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Universitario Torrecárdenas
OTHER
Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
OTHER