Okamura Aldo, de Mendonça Gabriel Maciel, Raduan Neto Jorge, de Moraes Vinicius Ynoe, Faloppa Flavio, Belloti João Carlos
Hospital Municipal do Campo Limpo Dr. Fernando Mauro Pires da Rocha, Estrada de Itapecerica, 1661 - Campo Limpo, São Paulo, SP, 05835-005, Brazil.
Hand, Arm and Shoulder Surgery Unit, Department of Orthopedics and Traumatology, Universidade Federal de São Paulo, UNIFESP/EPM, Rua Borges Lagoa, 778 Vila Clementino, São Paulo, SP, Brazil.
BMC Musculoskelet Disord. 2018 Mar 27;19(1):92. doi: 10.1186/s12891-018-2007-9.
A variety of cast options are available for the non-surgical treatment of distal radius fractures (DRF) in adults. However, the literature is inconclusive regarding the need to immobilize the elbow joint after reduction in order to prevent rotation of the forearm in order to maintain the reduction of DRF. This study aimed to evaluate the best method of immobilization between above-elbow (AE) and below-elbow (BE) cast groups at the end of six-month follow-up.
This is a randomized clinical trial with parallel groups and a blinded evaluator. There are two non-surgical interventions: AE and BE. Patients will be randomly assigned. A hundred twenty eight consecutive adult patients with acute (up to 7 days) displaced DRF of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen (AO) classification will be included. The primary outcome will be the maintenance of reduction by evaluation of radiographic parameters and Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Secondary outcomes include function measured by Patient Rated Wrist Evaluation (PRWE), pain measured by the Visual Analogue Scale (VAS), objective functional evaluation (goniometry and dynamometry) and rate of complications. Evaluations will be performed at 1, 2, 3, 4, 6, 8, 12 and 24 weeks. For the Student's t-test, a difference of 10 points in DASH score, with 95% confidence interval, a statistical power of 95%, and 20% sampling error. We consider an extra 10% for balancing follow up losses results in 64 patients per group.
Results from this study protocol will help to define the need for elbow immobilization in maintenance of reduction, as well as functional performance of below elbow cast versus above elbow cast immobilization during the immobilization period.
NCT03126175 ( http://clinicaltrials.gov ). April 24, 2017.
成人桡骨远端骨折（DRF）的非手术治疗有多种石膏固定方式可供选择。然而，关于复位后是否需要固定肘关节以防止前臂旋转从而维持DRF复位，目前文献尚无定论。本研究旨在评估在六个月随访期末，上臂（AE）石膏组和下臂（BE）石膏组之间的最佳固定方法。
这是一项平行组随机临床试验，评估者设盲。有两种非手术干预措施：AE和BE。患者将被随机分配。将纳入128例连续的成年急性（至多7天）移位型A2、A3、C1、C2或C3型DRF患者，根据AO（ Arbeitsgemeinschaft für Osteosynthesefragen）分类法进行分类。主要结局将通过影像学参数评估以及上肢、肩部和手部功能障碍问卷（DASH）来评估复位的维持情况。次要结局包括通过患者腕关节评估（PRWE）测量的功能、通过视觉模拟量表（VAS）测量的疼痛、客观功能评估（测角法和握力测量）以及并发症发生率。评估将在第1、2、3、4、6、8、12和24周进行。对于学生t检验，DASH评分差异为10分，置信区间为95%，统计效能为95%，抽样误差为20%。考虑到平衡随访失访情况额外增加10%，每组将有64例患者。
本研究方案的结果将有助于确定在维持复位过程中肘关节固定的必要性，以及在固定期间下臂石膏与上臂石膏固定的功能表现。
NCT03126175（http://clinicaltrials.gov）。2017年4月24日。
