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螺钉固定与半髋关节置换治疗老年股骨颈无移位骨折:一项多中心随机对照试验。

Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients: A Multicenter Randomized Controlled Trial.

机构信息

Department of Orthopaedic Surgery (F.C.D., S.B., and S.E.U.) and Health Services Research Unit (J.S.B.), Akershus University Hospital, Lørenskog, Norway.

Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

出版信息

J Bone Joint Surg Am. 2019 Jan 16;101(2):136-144. doi: 10.2106/JBJS.18.00316.

Abstract

BACKGROUND

Elderly patients with a displaced femoral neck fracture treated with hip arthroplasty may have better function than those treated with internal fixation. We hypothesized that hemiarthroplasty would be superior to screw fixation with regard to hip function, mobility, pain, quality of life, and the risk of a reoperation in elderly patients with a nondisplaced femoral neck fracture.

METHODS

In a multicenter randomized controlled trial (RCT), Norwegian patients ≥70 years of age with a nondisplaced (valgus impacted or truly nondisplaced) femoral neck fracture were allocated to screw fixation or hemiarthroplasty. Assessors blinded to the type of treatment evaluated hip function with the Harris hip score (HHS) as the primary outcome as well as on the basis of mobility assessed with the timed "Up & Go" (TUG) test, pain as assessed on a numerical rating scale, and quality of life as assessed with the EuroQol-5 Dimension-3 Level (EQ-5D) at 3, 12, and 24 months postsurgery. Results, including reoperations, were assessed with intention-to-treat analysis.

RESULTS

Between February 6, 2012, and February 6, 2015, 111 patients were allocated to screw fixation and 108, to hemiarthroplasty. At the time of follow-up, there was no significant difference in hip function between the screw fixation and hemiarthroplasty groups, with a 24-month HHS (and standard deviation) of 74 ± 19 and 76 ± 17, respectively, and an adjusted mean difference of -2 (95% confidence interval [CI] = -6 to 3; p = 0.499). Patients allocated to hemiarthroplasty were more mobile than those allocated to screw fixation (24-month TUG = 16.6 ± 9.5 versus 20.4 ± 12.8 seconds; adjusted mean difference = 6.2 seconds [95% CI = 1.9 to 10.5 seconds]; p = 0.004). Furthermore, screw fixation was a risk factor for a major reoperation, which was performed in 20% (22) of 110 patients who underwent screw fixation versus 5% (5) of 108 who underwent hemiarthroplasty (relative risk reduction [RRR] = 3.3 [95% CI = 0.7 to 10.0]; number needed to harm [NNH] = 6.5; p = 0.002). The 24-month mortality rate was 36% (40 of 111) for patients allocated to internal fixation and 26% (28 of 108) for those allocated to hemiarthroplasty (RRR = 0.4 [95% CI = -0.1 to 1.1]; p = 0.11). Two patients were lost to follow-up.

CONCLUSIONS

In this multicenter RCT, hemiarthroplasty was not found to be superior to screw fixation in reestablishing hip function as measured by the HHS (the primary outcome). However, hemiarthroplasty led to improved mobility and fewer major reoperations. The findings suggest that certain elderly patients with a nondisplaced femoral neck fracture may benefit from being treated with a latest-generation hemiarthroplasty rather than screw fixation.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

背景

与内固定治疗相比,接受髋关节置换术治疗的老年股骨颈骨折移位患者的功能可能更好。我们假设半髋关节置换术在髋关节功能、活动能力、疼痛、生活质量以及再次手术风险方面优于螺钉固定。

方法

在一项多中心随机对照试验(RCT)中,挪威≥ 70 岁的非移位(内翻或真正非移位)股骨颈骨折患者被分配接受螺钉固定或半髋关节置换术。评估者对治疗类型进行盲法评估,主要结局为 Harris 髋关节评分(HHS)评估髋关节功能,以及基于计时“Up & Go”(TUG)测试评估活动能力、数字评分量表评估疼痛以及 EuroQol-5 维度-3 级(EQ-5D)评估生活质量,分别在术后 3、12 和 24 个月进行评估。结果,包括再次手术,均采用意向治疗分析。

结果

2012 年 2 月 6 日至 2015 年 2 月 6 日,111 例患者被分配接受螺钉固定,108 例接受半髋关节置换术。在随访时,螺钉固定组和半髋关节置换组的髋关节功能无显著差异,24 个月 HHS(和标准差)分别为 74 ± 19 和 76 ± 17,调整后的平均差异为-2(95%置信区间[CI] = -6 至 3;p = 0.499)。接受半髋关节置换术的患者比接受螺钉固定的患者活动能力更强(24 个月 TUG = 16.6 ± 9.5 与 20.4 ± 12.8 秒;调整后的平均差异 = 6.2 秒[95%CI = 1.9 至 10.5 秒];p = 0.004)。此外,螺钉固定是主要再次手术的危险因素,110 例接受螺钉固定的患者中有 20%(22 例)接受了主要再次手术,而 108 例接受半髋关节置换术的患者中有 5%(5 例)接受了主要再次手术(相对风险降低[RRR] = 3.3[95%CI = 0.7 至 10.0];需要治疗的人数[NNH] = 6.5;p = 0.002)。接受内固定治疗的患者 24 个月死亡率为 36%(40/111),接受半髋关节置换术的患者为 26%(28/108)(RRR = 0.4[95%CI = -0.1 至 1.1];p = 0.11)。有 2 例患者失访。

结论

在这项多中心 RCT 中,半髋关节置换术在恢复 HHS(主要结局)测量的髋关节功能方面并未优于螺钉固定。然而,半髋关节置换术可提高活动能力并减少主要再次手术。这些发现表明,某些非移位股骨颈骨折的老年患者可能受益于接受最新一代半髋关节置换术治疗,而不是螺钉固定。

证据水平

治疗性 I 级。有关完整的证据水平说明,请参见作者指南。

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