Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft 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: Flexible intramedullary nail (FIN), Reduction auder general anesthesia and long arm cast.
- Кому может быть актуально
- Состояния в реестре: Both Bone Forearm Fracture, AO Classification 22D/2.1-5.2, 7-12 Year Old. Базовые параметры: 7 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
- 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 Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in 7 to 12 Years Old Children: A Study Protocol for a Randomized Controlled Trial
Обзор
The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.
Подробное описание
This is a multicenter, randomized superiority trial comparing closed reduction and cast immobilization to flexible intramedullary nails in 7-12 year old children with \> 10° of angulation and/or \> 10mm of shortening in displaced both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomized in 1:1 ratio to either treatment group. The study has a parallel non-randomized patient preference arm. Both treatments are performed under general anesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilized in a collar and cuff sling for 4 weeks. Data is collected at baseline and at each follow-up until 1 year.
Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.
The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.
Вмешательства
- Процедура Flexible intramedullary nail (FIN)
Both bone FIN - Процедура Reduction auder general anesthesia and long arm cast
Reduction and cast
Первичные конечные точки
- PROMIS Pediatric Item Bank v2.0 - Upper Extremity [Срок оценки: 12 months]
- Pro-supination [Срок оценки: 12 months]
Вторичные конечные точки (10)
- Quick Disabilities of the Arm, Shoulder and Hand score [Срок оценки: 6 weeks, 3, 6 and 12 months]
- Measurement Model for the Pediatric Quality of Life Inventory (PedsQL) [Срок оценки: 6 weeks, 3, 6 and 12 months]
- Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ) [Срок оценки: 6 weeks, 3, 6 and 12 months]
- Need for re-interventions [Срок оценки: 6 weeks, 3, 6 and 12 months]
- Rate of participants with malunion [Срок оценки: 6 weeks, 3, 6 and 12 months]
- Adverse effects [Срок оценки: 6 weeks, 3, 6 and 12 months]
- Cosmetic VAS [Срок оценки: 6 weeks, 3, 6 and 12 months]
- PROMIS Pediatric Item Bank v2.0 - Upper Extremity [Срок оценки: 6 weeks, 3, 6 months]
- Upper limb ROM [Срок оценки: 6 weeks, 3, 6 months]
- Return to sport/musical instrument and level [Срок оценки: 6 weeks, 3, 6 and 12 months]
Критерии участия
Критерии включения
- 7 to12 year old children
- Open distal radial physis
- Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
- More than 10 degrees of angulation
- with or without less than 10mm of shortening
Критерии исключения
- Patients with bilateral fractures
- Gustilo-Anderson grade I-III open fracture
- Neurovascular deficit
- Compartment syndrome
- Pathologic fracture
- Patient not able to give a written informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Финляндия · 5 центров
- HUS New Childrens Hospital — Helsinki
- Kuopio University Hospital — Kuopio
- Oulu University Hospital — Oulu
- Tampere University Hospital — Tampere
- Turku University Hospital — Turku
Публикации
- Grahn P, Sinikumpu JJ, Nietosvaara Y, Syvanen J, Salonen A, Ahonen M, Helenius I. Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7-12 years: a study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 20;11(8):e048248. doi: 10.1136/bmjopen-2020-048248. PMID 34417215
Идентификаторы
NCT: NCT04664517 · 78/1801/2020