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Войти в исследования Distal Radius Interventions for Fracture Treatment (DRIFT) trial: study protocol for a multicentre randomised clinical trial of completely translated distal radius fractures at paediatric hospitals in North America.
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.
Balmert Bonner Lauren, Janicki Joseph, Georgiadis Andrew, Truong Walter, Harris Beauvais Dorothy, Belthur Mohan, Daley Erika L, Franzone Jeanne, Howard Andrew, May Collin, Rockhold Frank, Schulz Jacob, Bailey Mary, Chiswell Karen, DeLaRosa Jesse, Brooks Jaysson T, Cantanzano Anthony A, Chan Andrea, Chu Alice, Dodwell Emily R, El-Hawary Ron, Ellis Henry, Fitzgerald Ryan, Frick Steven, Ganley Theodore J, Gargiulo Dominic, Gauthier Luke, Gill Corey S, Goldstein Rachel, Halsey Matthew F, Hardesty Christina, Ho Christine, Kaushal Neil, Lawrence John Todd, Lee R Jay, Leitch Khristinn K, Masrouha Karim, Mitchell Stuart, OMalley Natasha, Payares-Lizano Monica, Perry Daniel, Ramalingam Wendy, Rhodes Jason, Sanders Julia, Shah Apurva S, Sharkey Melinda, Silva Mauricio, Silva Selina, Thompson Rachael, Vorhies John, Wright James Gardner, Young Candace, Burgess Jamie, IMPACCT Consortium
Аннотация
METHODS AND ANALYSIS: Participants aged 4-10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).
ETHICS AND DISSEMINATION: Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.
TRIAL REGISTRATION NUMBER: NCT05131685.