Department of Trauma and Orthopaedic Surgery, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Barts Health NHS Trust, London, UK.
Bone Joint J. 2021 Feb;103-B(2):256-263. doi: 10.1302/0301-620X.103B.BJJ-2020-1404.R1. Epub 2021 Jan 3.
Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures.
We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures.
Overall, 437 and 443 participants were analyzed in the primary intention-to-treat analysis in XHS and SHS treatment groups respectively. There was a mean difference of 0.029 in adjusted utility index in favour of XHS with no evidence of a difference between treatment groups (95% confidence interval -0.013 to 0.070; p = 0.175). There was no evidence of any differences between treatment groups in any of the secondary outcomes. The pattern and overall risk of adverse events associated with both treatments was similar.
Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important. There was no evidence of a difference in the safety profile of the two treatments; both were associated with lower risks of revision surgery than previously reported. Cite this article: 2021;103-B(2):256-263.
髋部骨折的手术治疗极具挑战性；骨骼多孔，固定失败可能会导致灾难性后果。新型植入物可获得更好的临床效果。本研究比较了新型 X-Bolt 髋关节系统（XHS）与滑动髋螺钉（SHS）治疗脆弱性髋部骨折的临床效果。
我们进行了一项多中心、优效性、随机对照试验。在英国 10 家急性 NHS 医院招募年龄在 60 岁及以上的转子间髋部骨折患者。将参与者随机分配至 XHS 或 SHS 固定其骨折。共随机分配了 1128 名参与者，每组 564 名。参与者和结果评估者对治疗分配均不知情。主要结局是 4 个月时的欧洲五维健康量表 5 级健康状况（EQ-5D-5L）效用。预先指定效用的最小临床重要差异为 0.075。次要结局为 12 个月时的 EQ-5D-5L 效用、死亡率、居住状态、活动能力、翻修手术和影像学测量。
总体而言，在 XHS 和 SHS 治疗组的主要意向治疗分析中，分别有 437 名和 443 名参与者被纳入分析。XHS 组的调整后效用指数平均高出 0.029，两组间无差异（95%置信区间 -0.013 至 0.070；p = 0.175）。两组在任何次要结局上均无差异。两种治疗相关不良事件的模式和总体风险相似。
XHS 和 SHS 之间在 4 个月时的健康相关生活质量差异较小，且无临床意义。两种治疗方法的安全性特征无差异；两者都比之前报道的具有更低的翻修手术风险。
