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Войти в исследования Protocol of BRICS: Brazilian multicentric pragmatic randomised trial of surgical interventions for displaced diaphyseal clavicle fracture study: MIPO versus ORIF for the treatment of displaced midshaft clavicle fractures.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Mendes Adriano Fernando, Curado Rodrigo Fleury, Dias Jair Moreira, Mota Neto José Da, Carrazzone Oreste Lemos, Pagan Alexandre Rosa, Labronici Pedro José, Labronici Gustavo José, Goes Matheus Pires De Araújo, Mouraria Guilherme Grisi, Zogbi Daniel Romano, Brigatto Rafael Mulatti, Uehara Anderson, Parro Otávio Costa, Hisano Fernando Mitsuo, Teixeira Bruno De Souza, Silva Rafael Waldolato, Lazarini Rafael Fuchs, Godinho André Couto, Godinho Pedro Couto, França Flavio De Oliveira, Godinho Glaydson Gomes, Freitas José Marcio Alves, Mariosa Carlos Alberto Menezes, Souza Bruno Gonçalves Schröder E, De Oliveira Valdeci Manoel, De Simoni Leandro Furtado, Pereira Camila Corrêa, Antunes Filho Jurandir, Matsunaga Fabio Teruo, Belloti João Carlos, Tamaoki Marcel Jun Sugawara
Аннотация
METHODS AND ANALYSIS: The study proposed is a multicentric, pragmatic, randomised, open-label, superiority clinical trial between minimally invasive osteosynthesis and open reduction and internal fixation for surgical treatment of patients with displaced fractures of the clavicle shaft. In the proposed study, 190 individuals with displaced midshaft clavicle fractures, who require surgery as treatment, will be randomised. The assessment will occur at 2, 6, 12, 24 and 48 weeks, respectively. The primary outcome of the study will be the number of complications and reoperations. For sample size calculation, a moderate effective size between the techniques was considered in a two-tailed test, with 95% confidence and 90% power. Complications include cases of infection, hypertrophic scarring, non-union, refracture, implant failure, hypoesthesia, skin irritation and shoulder pain. Reoperations are defined as the number of surgeries for pseudoarthrosis, implant failure, infection and elective removal of the implant.
ETHICS AND DISSEMINATION: Study approved by the institutional ethics committee (number 34249120.9.0000.5505-V.3). The results will be disseminated by publications in peer-reviewed journals and presentations in medical meetings.
TRIAL REGISTRATION NUMBER: RBR-3czz68)/UTN U1111-1257-8953.