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Набор скоро начнётся NCT06983353

Guided Growth Technique Use In Treatment Of Hip Sublaxation In CP Childern

Без фазы С лечением Cerebral Palsy (CP) Guided Growth

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: transphyseal screw.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy (CP), Guided Growth. Базовые параметры: 3 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Transphyseal Screw Guided Growth Technique for Correction of Coxa Valga in Cerebral Palsy Children With Hip Sublaxation A Pilot Study

Обзор

To evaluate the change in femoral neck-shaft angle (coxa valga) following transphyseal screw insertion in children with CP.

Подробное описание

The hip is one of the most common involved joint in cerebral palsy. Hip displacement occurs in more than 33% of children with cerebral palsy, with a higher prevalence in nonambulatory children. Hip displacement in this population is typically progressive. Hip dislocation can result in pain and difficulty with sitting and perineal care. Hip Surveillance in Children with Cerebral Palsy.

Traditional surgical management, typically reserved for hips with a migration percentage of 40% or more, includes hip reconstruction involving soft tissue releases, femoral and pelvic osteotomies. These procedures are associated with significant perioperative morbidity, including pain; increased blood loss; and lengthy anesthetic and inpatient recovery times, often complicated with peri-operative infections. With improved surgical techniques, orthopedic implants and enhanced postoperative pathways, weightbearing can be resumed shortly after surgery; however, traditional treatment commonly included a period of non-weight-bearing, with some surgeons preferring to augment their reconstruction with a hip spica or abduction brace .

Guided growth procedures are well established in the treatment for the gradual correction of angular and rotational limb deformities in children. Anterior hemiepiphysiodesis of the distal femur has been shown to be effective in the treatment of fixed flexion deformity of the knee when compared to traditional osteotomies. shows intra-operative radiographs of this minimally invasive technique, which has been recently applied to the proximal femoral physis for various conditions. By placing a screw over the physis on the medial side, the tethering that occurs on the medial side will result in progressive varus of the proximal femur. It is understood that this manipulation of the proximal femoral anatomy can alter the course of secondary acetabular dysplasia .Furthermore, it is recognized that guided growth procedures of the proximal femoral physis can be carried out as day case procedures, require a shorter operating time and allow for immediate weight bearing/standing when performed in non-ambulatory patients.

Type of the study: Prospective cohort study Study Setting: Assiut University Hospitals, Department of Orthopaedics and Traumatology

Preoperative assessment :

A-Clinical for GMFCS B- Radiological AP and Lateral pelvis for the migration percentage (MP), head/neck-shaft angle (HSA/NSA) and acetabular index (AI) Procedure: Insertion of a transphyseal fully threaded cannulated screw at proper size across the infromedial proximal femoral physis under fluoroscopic guidance +/- soft tissue release , Abductor brace , hip spicca , and ankle foot orthosis .

* Postoperative Care: * Weight-bearing as tolerated. * Physical therapy to improve hip abductor strength and range of motion. * Regular follow-up at 1.5, 3, 6, 12, and 24 months and uptill .

Вмешательства

  • Устройство transphyseal screw
    transphyseal screw in proximal femoral physis

Первичные конечные точки

  • Change in femoral neck-shaft angle (measured on anteroposterior pelvic radiographs). [Срок оценки: - Regular follow-up at 1.5, 3, 6, 12, and 24 months .]

Критерии участия

Критерии включения

  • children aged 3-12 yrs diagnosed with CP ( GMFCS level l\_lV )
  • Neck-Shaft angle >150
  • early hip sub laxation ( migration percentage < 50% )

Критерии исключения

  • Sever hip sub laxation ( migration percentage> 50 % )
  • Children below 3 yrs and above 12
  • Pathological bone
  • medical contraindications to surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Assiut university hospital — Asyut

Публикации

  • Hsieh HC, Wang TM, Kuo KN, Huang SC, Wu KW. Guided Growth Improves Coxa Valga and Hip Subluxation in Children with Cerebral Palsy. Clin Orthop Relat Res. 2019 Nov;477(11):2568-2576. doi: 10.1097/CORR.0000000000000903. PMID 31425278
  • Lebe M, van Stralen RA, Buddhdev P. Guided Growth of the Proximal Femur for the Management of the 'Hip at Risk' in Children with Cerebral Palsy-A Systematic Review. Children (Basel). 2022 Apr 25;9(5):609. doi: 10.3390/children9050609. PMID 35626786

Идентификаторы

NCT: NCT06983353 · guided growth in cp childern

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗