Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm 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: Cast immobilization, Percutaneus pinning.
- Кому может быть актуально
- Состояния в реестре: Pediatric Overriding Distal Metaphyseal Radius Fractures. Базовые параметры: до 10 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
- Финляндия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Casting in Finger-trap Traction Without Reduction Versus Closed Reduction and Percutaneous Pin Fixation of Dorsally Displaced, Overriding Distal Metaphyseal Radius Fractures in Under Eleven Years Old Children
Обзор
This is a randomized controlled trial comparing casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in under eleven years old children.
Подробное описание
Overriding pediatric distal radius fractures have been managed with anatomical reduction performed under anesthesia with or without percutaneous pinning. This research protocol was developed due to good results reported on leaving the fractures in an overriding position.
In this randomized controlled trial, we will compare objective outcomes between casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in children.
Inclusion criteria are patients younger than 11 years old (Tanner 0) with completely overriding distal radius fractures. At the emergency department patients are randomized into two groups: finger trap traction and cast immobilization (experimental group) and anatomic reduction and percutaneous pin fixation (control group).
The current controversy is whether cast immobilization alone is an adequate stabilization or whether percutaneous pin fixation is more appropriate for displaced, complete, distal forearm (overriding) metaphyseal fractures. The objectives of this trial are to compare the outcomes between conservative treatment with finger trap method for completely displaced distal radius fractures and surgical treatment with percutaneous pinning. Our null hypothesis is that there are no radiological or clinically relevant differences in outcome measures between the two treatment groups. We consider non-inferiority proven if there is no clinically significant difference at 6 months between the two treatments groups in the primary outcome: ratio (%) of forearm rotation and wrist extension-flexion range of motion (ROM) compared to the non-affected side at 6 months (non-inferiority margin 10%).
Вмешательства
- Процедура Cast immobilization
Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction. - Процедура Percutaneus pinning
Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
Первичные конечные точки
- Wrist ROM [Срок оценки: 6 months]
- Forearm ROM [Срок оценки: 6 months]
Вторичные конечные точки (8)
- Patient-reported pain [Срок оценки: 1 and 4 weeks, 3 and 6 months, 1 year]
- Patient-reported outcome (PROM) [Срок оценки: 4 weeks, 3 and 6 months, 1 year]
- Radiographic outcomes [Срок оценки: 1 and 4 weeks, 3 and 6 months, 1 year]
- Grip strength [Срок оценки: 3 and 6 months, 1 year]
- Forearms length [Срок оценки: 3 and 6 months, 1 year]
- Wrist ROM [Срок оценки: 3 months, 1 year]
- Forearm ROM [Срок оценки: 3 months, 1 year]
- Overall satisfaction [Срок оценки: 6 months]
Критерии участия
Критерии включения
- Child with open epiphysis with closed overriding metaphyseal distal radial fracture with or without an associated fracture of the ulna
- Normal communication development (languages Finnish, Swedish, English)
Критерии исключения
- Bilateral forearm injuries
- Gustillo-Anderson grade II or III open fracture
- Galeazzi fracture-dislocation
- Polytrauma
- Neurovascular injury of the ipsilateral upper extremity
- History of a displaced forearm fracture
- Underlying disease affecting fracture healing
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Финляндия · 1 центр
- New Children's Hospital — Helsinki
Публикации
- Laaksonen T, Stenroos A, Puhakka J, Kosola J, Kautiainen H, Ramo L, Nietosvaara Y. Casting in finger trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, over-riding distal metaphyseal radius fractures in children under 11 years old: a study protocol of a randomised controlled trial. BMJ Open. 2021 May 26;11(5):e045689. doi: 10.1136/bmjopen-2 PMID 34039573
Идентификаторы
NCT: NCT04323410 · PediatricOverridingFractures