老年桡骨远端骨折手术的随机与观察性联合研究（CROSSFIRE）——研究方案
A combined randomised and observational study of surgery for fractures in the distal radius in the elderly (CROSSFIRE)-a study protocol.
作者信息
Harris Ian A, Naylor Justine M, Lawson Andrew, Buchbinder Rachelle, Ivers Rebecca, Balogh Zsolt, Smith Paul, Mittal Rajat, Xuan Wei, Howard Kirsten, Vafa Arezoo, Yates Piers, Rieger Bertram, Smith Geoff, Elkinson Ilia, Kim Woosung, Chehade Mellick, Sungaran Jai, Latendresse Kim, Wong James, Viswanathan Sameer, Richardson Martin, Shrestha Kush, Drobetz Herwig, Tran Phong, Loveridge Jeremy, Page Richard, Hau Raphael, Bingham Roger, Mulford Jonathan, Incoll Ian
机构信息
Ingham Institute for Applied Medical Research, Whitlam Orthopaedic Research Centre, Sydney, Australia.
University of New South Wales, Sydney, Australia.
出版信息
BMJ Open. 2017 Jun 23;7(6):e016100. doi: 10.1136/bmjopen-2017-016100.
UNLABELLED
Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating. Surgical management involves significant costs and risks compared with conservative management. High-level evidence is required to address practice variation, justify costs and to provide the best clinical outcomes for patients.
METHODS AND ANALYSIS
This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether plating leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques but will also follow consenting patients who are unwilling to be randomised in a separate, observational cohort. Inclusion of non-randomised patients addresses selection bias, provides practice and outcome insights about standard care, and improves the generalisability of the results from the randomised trial.
ETHICS AND DISSEMINATION
CROSSFIRE(Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly) was reviewed and approved by The Hunter New England HREC (HNEHREC Reference No: 16/02/17/3.04). The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Results will be incorporated in clinical recommendations and practice guidelines produced by professional bodies.
REGISTRATION
CROSSFIRE has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR: ACTRN12616000969460).
未标注
桡骨远端骨折很常见，各年龄组均有发生。由于骨质疏松和跌倒风险增加，老年人群中的发病率较高。老年患者桡骨远端骨折的治疗方法差异很大，从闭合复位石膏固定到切开复位钢板固定。钢板固定是目前最常见的手术治疗方法。虽然有证据表明某些形式的手术固定相对于保守治疗没有显著优势，且不同手术技术之间也没有差异，但缺乏证据比较两种最常用的治疗方法：闭合复位石膏固定与钢板固定。与保守治疗相比，手术治疗涉及高昂的成本和风险。需要高质量的证据来解决治疗方法的差异、证明成本合理性并为患者提供最佳临床结果。
方法与分析
这项务实的多中心随机对照有效性试验旨在确定对于60岁及以上成年人的移位桡骨远端骨折，钢板固定是否能带来更好的疼痛缓解和功能恢复，且比闭合复位石膏固定更具成本效益。该试验将比较这两种技术，但也将跟踪那些不愿意被随机分组的同意参与的患者，将他们纳入一个单独的观察队列。纳入非随机患者可解决选择偏倚问题，提供有关标准治疗的实践和结果见解，并提高随机试验结果的普遍性。
伦理与传播
“CROSSFIRE（老年桡骨远端骨折手术的随机与观察性联合研究）”已获得猎人新英格兰人类研究伦理委员会（HNEHREC）的审查和批准（HNEHREC参考编号：16/02/17/3.04）。试验结果将发表在同行评审期刊上，并将通过各种媒体形式传播。结果将纳入专业机构制定的临床建议和实践指南中。
注册情况
“CROSSFIRE”已在澳大利亚和新西兰临床试验注册中心（ANZCTR：ACTRN12616000969460）注册。
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