Transverse Pinning Versus Antegrade Intramedullary Pinning for Neck and Shaft Metatarsal Fractures
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Transverse Pinning for neck and shaft Metatarsal Fractures, Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures.
- Кому может быть актуально
- Состояния в реестре: Transverse Pinning for Metatarsal Fractures, Versus Antegrade Intramedullary Pinning for Metatarsal Fractures. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
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- Египет
- Следующий шаг
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Обзор
The aim of this prospective randomized controlled clinical trial study is to compare clinical, functional and radiological results of transverse pinning and antegrade intramedullary pinning for neck and shaft metatarsal fractures
Подробное описание
Metatarsal fractures account for 35% of fractures of the foot and 5% of all skeletal fractures. They may be single or multiple, and isolated or associated with ligament lesions around the tarsometatarsal joint or with other fractures (1).
Metatarsal fractures result from low-energy trauma in almost 85% of cases. Crush injury accounts for 41% of high-energy foot trauma. Fatigue fracture of metatarsals account for 38% of all fatigue fractures. The second and third metatarsals (M2, M3) are the most affected (2). The fifth metatarsal is involved in up to 70% of metatarsal fractures and approximately 80% of these are proximal (3).
The overall aim of treatment is to restore the alignment of the metatarsals thereby maintaining the longitudinal and transverse arches of the forefoot. This allows normal weight distribution under the metatarsal heads. Nondisplaced fractures and fractures of the second to fourth metatarsals with displacement in the axial plane can be treated conservatively with protected weight bearing in a hard-soled shoe or boot for 4-6 weeks.
Several surgical methods have been introduced to treat displaced fractures when satisfactory reduction and stability cannot be obtained by closed reduction techniques. Among the various surgical techniques available for the fixation of metatarsal fractures, include open reduction internal fixation by screw or mini plate , transverse pinning and antegrade intramedullary pinning Transverse pinning and antegrade intramedullary pinning have gained widespread acceptance due to their minimally invasive stabilization of metatarsal fractures to enable adequate fracture healing in a correct position to restore anatomy and biomechanics of the foot (4).
Antegrade intramedullary pinning technique using Kirschner wire (K-wire) allowed displaced metatarsal fractures to be easily reduced without opening the fracture site, and at the same time secured firm fixation without infringing the metatarsophalangeal (MTP) joint. Furthermore, the described method allowed immediate joint motion and caused no motion or pain limitation, and thus allowed rapid return to daily activities (5).
The purpose of this study will be to compare the clinical, functional and radiological results of transverse pinning and antegrade intramedullary pinning for neck and shaft metatarsal fractures.
Вмешательства
- Процедура Transverse Pinning for neck and shaft Metatarsal Fractures
⦁ Transverse Pinning Under spinal anaesthesia, the patient will be placed in the supine position. Under the guidance of an image intensifier, gentle longitudinal traction will be applied and percutaneous manipulation will be done using k wires and digital pressure. - Процедура Antegrade Intramedullary Pinning for neck and shaft Metatarsal Fractures
Antegrade Intramedullary Pinning Under spinal anesthesia, the patient will be placed in the supine position. Under guidance of an image intensifier, a small incision will be made over the dorsal aspect of the foot at the proximal end of the fractured metatarsal. Soft tissue will be dissected, taking care not to injure neurovascular structures and extensor tendons. An entry hole will be then made with a 2.0-mm drill bit. A 1.6-mm K-wire will be prepared with distal end bent through 5 and the prep
Первичные конечные точки
- ⦁ Time to bone union [Срок оценки: 12 weeks]
Вторичные конечные точки (3)
- ⦁ Foot function using the Foot and Ankle Ability Measure (FAAM) [Срок оценки: 6 months]
- ⦁ Pain intensity using the visual analog scale (VAS) [Срок оценки: 6 months]
- ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications. ⦁ Incidence of complications.⦁ Incidence of complications. ⦁ Incidence of complications. [Срок оценки: 6 months]
Критерии участия
Критерии включения
- ⦁ Age ≥ 18 years.
- Both sexes.
- Displaced metatarsal neck or shaft fractures.
- Unstable fracture for which reduction could not be maintained after closed reduction.
- Open fractures
Критерии исключения
- ⦁ Fractures combined with Lisfranc injury.
- Other concomitant fractures.
- Non displaced fracture
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
Египет · 1 центр
- Sohag University Hospital — Sohag
Идентификаторы
NCT: NCT07528092 · soh-med-26-1-5MS