Trials · 2011
Rationale and design of the plate or pin (POP) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
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.
Wijdicks Frans J G, Houwert R Marijn, Dijkgraaf Marcel G W, De Lange Diederik H, Meylaerts Sven A G, Verhofstad Michiel H J, Verleisdonk Egbert J J M
Аннотация
BACKGROUND: To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN) with a Titanium Elastic Nail (TEN) for adults with a dislocated midshaft clavicular fracture.
METHODS/DESIGN: Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures.
DISCUSSION: Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed.
TRIAL REGISTRATION: The POP study is registered in the Dutch Trial Register (NTR NTR2438).
METHODS/DESIGN: Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures.
DISCUSSION: Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed.
TRIAL REGISTRATION: The POP study is registered in the Dutch Trial Register (NTR NTR2438).
Предметные рубрики MeSH
AdolescentAdultAgedBone NailsBone PlatesClavicleDisability EvaluationFemaleFracture Fixation, InternalFracture Fixation, IntramedullaryFracture HealingFractures, BoneHumansMaleMiddle AgedNetherlandsPain MeasurementPostoperative PainProspective StudiesProsthesis DesignRadiographyResearch DesignShoulder DislocationTime FactorsTitaniumTrauma CentersTreatment OutcomeYoung Adult