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微创前肌保留与经臀入路髋关节置换术治疗股骨颈骨折的前瞻性随机对照研究:纳入 190 例老年患者。

Minimally invasive anterior muscle-sparing versus a transgluteal approach for hemiarthroplasty in femoral neck fractures-a prospective randomised controlled trial including 190 elderly patients.

机构信息

Department of Orthopaedics and Traumatology, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland.

Clinic for Orthopaedics and Trauma Surgery Stephanshorn, Brauerstrasse 95, 9016, St. Gallen, Switzerland.

出版信息

BMC Geriatr. 2018 Sep 21;18(1):222. doi: 10.1186/s12877-018-0898-9.

Abstract

BACKGROUND

The relevance of femoral neck fractures (FNFs) increases with the ageing of numerous societies, injury-related decline is observed in many patients. Treatment strategies have evolved towards primary joint replacement, but the impact of different approaches remains a matter of debate. The aim of this trial was to evaluate the benefit of an anterior minimally-invasive (AMIS) compared to a lateral Hardinge (LAT) approach for hemiarthroplasty in these oftentimes frail patients.

METHODS

Four hundred thirty-nine patients were screened during the 44-months trial, aiming at the evaluation of 150 patients > 60 yrs. of age. Eligible patients were randomised using an online-tool with completely random assignment. As primary endpoint, early mobility, a predictor for long-term outcomes, was evaluated at 3 weeks via the "Timed up and go" test (TUG). Secondary endpoints included the Functional Independence Measure (FIM), pain, complications, one-year mobility and mortality.

RESULTS

A total of 190 patients were randomised; both groups were comparable at baseline, with a predominance for frailty-associated factors in the AMIS-group. At 3 weeks, 146 patients were assessed for the primary outcome. There was a reduction in the median duration of TUG performance of 21.5% (CI [- 41.2,4.7], p = 0.104) in the AMIS-arm (i.e., improved mobility). This reduction was more pronounced in patients with signs of frailty or cognitive impairment. FIM scores increased on average by 6.7 points (CI [0.5-12.8], p = 0.037), pain measured on a 10-point visual analogue scale decreased on average by 0.7 points (CI: [- 1.4,0.0], p = 0.064). The requirement for blood transfusion was lower in the AMIS- group, the rate of complications comparable, with a higher rate of soft tissue complications in the LAT-group. The mortality was higher in the AMIS-group.

CONCLUSION

These results, similar to previous reports, support the concept that in elderly patients at risk of frailty, the AMIS approach for hemiarthroplasty can be beneficial, since early mobilisation and pain reduction potentially reduce deconditioning, morbidity and loss of independence. The results are, however, influenced by a plethora of factors. Only improvements in every aspect of the therapeutic chain can lead to optimisation of treatment and improve outcomes in this growing patient population.

TRIAL REGISTRATION

www.clinicaltrials.gov : NCT01408693 (registered August 3rd 2011).

摘要

背景

随着许多社会人口老龄化,股骨颈骨折(FNFs)的相关性增加,许多患者的受伤相关能力下降。治疗策略已经朝着初次关节置换发展,但不同方法的影响仍然存在争议。本试验的目的是评估与外侧 Hardinge(LAT)入路相比,前微创(AMIS)入路在这些体弱患者中进行半髋关节置换的优势。

方法

在 44 个月的试验中,对 439 名患者进行了筛选,旨在评估 150 名年龄大于 60 岁的患者。使用在线工具完全随机分配对符合条件的患者进行随机分组。主要终点是通过“计时起立行走”测试(TUG)在 3 周时评估早期活动能力,这是长期结果的预测指标。次要终点包括功能独立性测量(FIM)、疼痛、并发症、一年的活动能力和死亡率。

结果

共随机分配了 190 名患者;两组基线时无差异,AMIS 组以与虚弱相关的因素为主。在 3 周时,对 146 名患者进行了主要结局评估。AMIS 组 TUG 表现的中位数持续时间减少了 21.5%(CI [-41.2,4.7],p=0.104),即移动能力得到改善。在有虚弱或认知障碍迹象的患者中,这种改善更为明显。FIM 评分平均增加了 6.7 分(CI [0.5-12.8],p=0.037),10 分视觉模拟量表上的疼痛平均降低了 0.7 分(CI:[-1.4,0.0],p=0.064)。AMIS 组的输血需求较低,并发症发生率相当,LAT 组的软组织并发症发生率较高。AMIS 组的死亡率较高。

结论

这些结果与之前的报告相似,支持这样的概念,即在有虚弱风险的老年患者中,AMIS 入路进行半髋关节置换术可能是有益的,因为早期活动和疼痛减轻可能会减少去适应、发病率和丧失独立性。然而,结果受到众多因素的影响。只有治疗链的各个方面都得到改善,才能优化治疗并改善这一不断增长的患者群体的治疗效果。

试验注册

www.clinicaltrials.gov:NCT01408693(2011 年 8 月 3 日注册)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07fb/6151034/d9bd99b166ce/12877_2018_898_Fig1_HTML.jpg

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