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首页> 外文期刊>BMC Musculoskeletal Disorders >The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults
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The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults

机译：铸造研究方案：一种群集随机试验，评估周向铸造与石膏夹板对成人骨折骨折骨折裂缝的影响

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There is no consensus concerning the?optimal casting technique for displaced distal radius fractures (DRFs) following closed reduction. This study evaluates whether a splint or a circumferential cast is most optimal to prevent fracture redisplacement in adult patients with a reduced DRF. Additionally, the cost-effectiveness of both cast types will be calculated. This multicenter cluster randomized controlled trial will compare initial immobilization with a circumferential below-elbow cast versus a below-elbow plaster splint in reduced DRFs. Randomization will take place on hospital-level (cluster, n?=?10) with a cross-over point halfway the inclusion of the needed number of patients per hospital. Inclusion criteria comprise adult patients (≥ 18?years) with a primary displaced DRF which is treated conservatively after closed reduction. Multiple trauma patients (Injury Severity Score?≥?16), concomitant ulnar fractures (except styloid process fractures) and patients with concomitant injury on the ipsilateral arm or inability to complete study forms will be excluded. Primary study outcome is fracture redisplacement of the initial reduced DRF. Secondary outcomes are patient-reported outcomes assessed with the Disability Arm Shoulder Hand score (DASH) and Patient-Rated Wrist Evaluation score (PRWE), comfort of the cast, quality of life assessed with the EQ-5D-5L questionnaire, analgesics use, cost-effectiveness and (serious) adverse events?occurence. In total, 560 patients will be included and followed for 1 year. The estimated time required for inclusion will be 18?months. The CAST study will provide evidence whether the type of cast immobilization is of influence on fracture redisplacement in distal radius fractures. Extensive follow-up during one year concerning radiographic, functional and patient reported outcomes will give a broad view on DRF recovery. Registered in the Dutch Trial Registry on January 14th 2020. Registration number: NL8311 .
机译：闭合后，对位移远端裂缝（DRF）无关的铸造技术没有达成共识。该研究评估了夹板或圆周铸件是否最佳，以防止成年患者的裂缝重新剥离减少的DRF。另外，将计算转换类型的成本效益。该多中心群集随机对照试验将使初始固定与肘部下方铸造与下方的肘部碎屑夹在减少的DRF中的初始固定。随机化将在医院级别（群集，n？=？10），在中途的交叉点中间包含所需数量的每张医院。纳入标准包含成年患者（≥18岁），主要位移的DRF，闭合后保守处理。多发性创伤患者（损伤严重程度评分？≥16），伴随尺骨骨折（除氏型工艺骨折外）和伴随着同侧臂或无法完成研究表格的患者将被排除在外。初级研究结果是裂缝重新剥离初始减少的DRF。二次结果是患者报告的结果评估了残疾臂肩部分数（仪表率）和患者额定手腕评估得分（PRWE），舒适的铸造，生活质量评估为EQ-5D-5L调查问卷，镇痛药使用，成本效益和（严重）不良事件？发生。总共包括560名患者，并遵循1年。包含所需的估计时间为18个月。数月。施放研究将提供证据，施放固定的类型是否对远端半径骨折的裂缝重新剥离是影响。关于射线照相，功能和患者报告结果的一年内的广泛随访将为DRF恢复提供广阔的观点。在1月14日在荷兰试验登记处注册。注册号：NL8311。

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