Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial.
Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial.
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DOI：
10.1016/s0140-6736(17)30066-1
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发表时间：
2017-04-15
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通讯作者：
Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) Investigators
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作者：
Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) Investigators
髋部骨折手术后再手术率很高。我们研究了滑动髋螺钉与松质骨螺钉对再次手术风险和其他关键结局的影响。在这项国际性、多中心、分配隐蔽的随机对照试验中，我们从8个国家的81个临床中心招募了50岁或以上需要骨折固定的低能量髋部骨折患者。患者通过集中计算机系统最小化分配，接受单个大直径螺钉和侧板（滑动髋关节螺钉）或当前标准治疗，多个小直径松质骨螺钉。外科医生和患者未设盲，但数据分析员在进行分析时对治疗组保持盲态。主要结局是初次手术后24个月内髋关节再次手术，以促进骨折愈合、缓解疼痛、治疗感染或改善功能。分析遵循意向治疗原则。本研究注册于ClinicalTrials.gov，编号NCT 00761813。在2008年3月3日至2014年3月31日期间，我们将1108例患者随机分配接受滑动髋关节螺钉（n=557）或松质骨螺钉（n=551）。在主要分析中，24个月内的再次手术在手术固定类型方面没有差异：滑动髋螺钉组542例患者中的107例（20%）与松质骨螺钉组537例患者中的117例（22%）（风险比[HR] 0.83，95% CI 0.63-1.09; p=0.18）。滑动髋螺钉组的缺血性坏死比松质骨螺钉组更常见（50例患者[9%] vs 28例患者[5%]; HR 1.91，1.06-3.44; p=0.0319）。然而，两组之间的医学相关不良事件数量没有显著差异（p=0.82;附录）;这些事件包括肺栓塞（2例患者[<1%] vs 4例[1%]; p=0.41）和败血症（7例[1%] vs 6例[1%]; p=0.79）。在再手术率方面，滑动髋螺钉没有显示出优势，但某些患者组（吸烟者和颈骨折移位或基底骨折患者）使用滑动髋螺钉可能比松质骨螺钉更好。美国国立卫生研究院、加拿大卫生研究院、Stichting NutsOhra、荷兰卫生研究与发展组织、医师服务公司。
Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0.83, 95% CI 0.63–1.09; p=0.18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1.91, 1.06–3.44; p=0.0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0.82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0.41) and sepsis (seven [1%] vs six [1%]; p=0.79). In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians’ Services Incorporated.