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Набор скоро начнётся NCT07558941

Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?

Без фазы С лечением Humeral Fractures

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: Conservative treatment by casting, surgical treatment via percutaneous pinning UGA.
Кому может быть актуально
Состояния в реестре: Humeral Fractures. Базовые параметры: 1 год — 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Randomized Controlled Trial

Обзор

The primary aim of this research is to compare the efficacy of conservative treatment versus surgical treatment for Gartland type II supracondylar humerus fractures in children. The comparison focuses on assessing differences in clinical outcomes functional recovery times, and complication rates between the two treatment groups.

Подробное описание

Supracondylar Humerus Fractures are the most common type of elbow fracture in children, typically occurring between the ages of five and seven. These injuries are critical due to their proximity to major neurovascular structures, making prompt and appropriate management essential to prevent severe complications. The vast majority (approximately 98%) of SCHFs are extension-type injuries, resulting from a fall onto an outstretched hand with the elbow hyperextended.

Classification: The Gartland System The classification is based on the degree of displacement of the distal fragment relative to the proximal fragment, as seen on a lateral radiograph.

Type I stable, nondisplaced fractures are managed non-operatively.

* Treatment: Immobilization in a long-arm cast or splint for 3 to 4 weeks, typically in 90 degrees of flexion, followed by early mobilization . * Goal: Pain control and protection from further displacement. Type II FracturesThese fractures are unstable in extension but maintain some stability due to the intact posterior cortex. Management remains a point of controversy, with both conservative and surgical options being utilized.•Conservative Option: Closed reduction (CR) and casting, often reserved for less displaced or stable Type IIA fractures.•Surgical Option: Closed Reduction and Percutaneous Pinning (CRPP) is the preferred surgical method, especially for unstable Type IIB fractures (those with rotational instability).

Type III and IV are highly unstable fractures that require urgent intervention to achieve and maintain reduction .

Treatment: Closed Reduction and Percutaneous Pinning (CRPP) is the mainstay of treatment .Open reduction may be necessary if closed reduction fails or if there is a vascular compromise requiring exploration.

•Goal: Anatomical reduction and stable fixation to prevent malunion and neurovascular complications.

Вмешательства

  • Другое Conservative treatment by casting
    Closed reduction of Gartland type II supracondylar humeral fracture under appropriate analgesia or anesthesia, followed by immobilization using an above-elbow cast. Patients will undergo regular clinical and radiographic follow-up to monitor fracture alignment, healing, and functional recovery.
  • Процедура surgical treatment via percutaneous pinning UGA
    surgical treatment vis Closed reduction and percutaneous pinning under general anesthesia. Postoperative care includes clinical and radiographic follow-up to assess fracture healing, alignment, and potential complications.

Первичные конечные точки

  • Functional outcome assessed by Modified Disabilities of the Arm, Shoulder and Hand (QuickDASH) score [Срок оценки: 1 year]
Вторичные конечные точки (8)
  • Elbow flexion range of motion (degrees) [Срок оценки: 1 month, 3 months, and 6 months post-intervention]
  • Elbow extension range of motion (degrees) [Срок оценки: 1 month, 3 months, and 6 months post-intervention]
  • Pain assessed using Visual Analog Scale (VAS) [Срок оценки: 1 month, 3 months, and 6 months post-intervention]
  • Baumann angle (degrees) [Срок оценки: Immediately post-reduction and at 6 months]
  • Anterior humeral line alignment (normal/abnormal) [Срок оценки: Immediately post-reduction and at 6 months]
  • Loss of reduction (yes/no) [Срок оценки: Up to 6 months post-intervention]
  • Incidence of nerve injury (yes/no) [Срок оценки: Up to 6 months post-intervention]
  • Incidence of infection (yes/no) [Срок оценки: Up to 6 months post-intervention]

Критерии участия

Критерии включения

  • Patients with Gartland type II supracondylar humerus fractures with age between 1-12 years old treated at the AUH

Критерии исключения

  • Gartland Type I, III, or IV fractures.
  • Open fractures.
  • Associated neurovascular injury (e.g., absent radial pulse, documented nerve palsy).
  • Patients with another injury in the same limb
  • Pathological fractures.
  • Pre-existing elbow pathology or congenital deformity.
  • Inability to comply with follow-up protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07558941 · Supracondyler humeral fracture

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗