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老年人囊内型髋部骨折内固定植入物。

Internal fixation implants for intracapsular hip fractures in older adults.

机构信息

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.

Department of Trauma and Orthopaedics, The James Cook University Hospital, Middlesbrough, UK.

出版信息

Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD013409. doi: 10.1002/14651858.CD013409.pub2.


DOI:10.1002/14651858.CD013409.pub2
PMID:33687067
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8092427/
Abstract

BACKGROUND: Hip fractures are a major healthcare problem, presenting a huge challenge and burden to patients, healthcare systems and society. The increased proportion of older adults in the world population means that the absolute number of hip fractures is rising rapidly across the globe. The majority of hip fractures are treated surgically. This review evaluates evidence for types of internal fixation implants used in joint-preserving surgery for intracapsular hip fractures. OBJECTIVES: To determine the relative effects (benefits and harms) of different implants for the internal fixation of intracapsular hip fractures in older adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, Web of Science, Cochrane Database of Systematic Reviews, Epistemonikos, Proquest Dissertations and Theses, and National Technical Information Service in July 2020. We also searched clinical trials databases, conference proceedings, reference lists of retrieved articles and conducted backward-citation searches. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing implants used for internal fixation of fragility intracapsular proximal femoral fractures in older adults. Types of implants were smooth pins (these include pins with fold-out hooks), screws, or fixed angle plates. We excluded studies in which all or most fractures were caused by specific pathologies other than osteoporosis or were the result of a high energy trauma. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. One review author extracted data and assessed risk of bias which was checked by a second review author. We collected data for seven outcomes: activities of daily living (ADL), delirium, functional status, health-related quality of life (HRQoL), mobility, mortality (reported within four months of surgery as early mortality, and at 12 months since surgery), and unplanned return to theatre for treating a complication resulting directly or indirectly from the primary procedure (such as deep infection or non-union). We assessed the certainty of the evidence for these outcomes using GRADE. MAIN RESULTS: We included 38 studies (32 RCTs, six quasi-RCTs) with 8585 participants with 8590 intracapsular fractures. The mean ages of participants in the studies ranged from 60 to 84 years; 73% were women, and 38% of fractures were undisplaced. We report here the findings of the four main comparisons, which were between different categories of implants. We downgraded the certainty of the outcomes for imprecision (when data were available from insufficient numbers of participants or the confidence interval (CI) was wide), study limitations (e.g. high or unclear risks of bias), and inconsistency (when we noted substantial levels of statistical heterogeneity). Smooth pins versus fixed angle plate (four studies, 1313 participants) We found very low-certainty evidence of little or no difference between the two implant types in independent mobility with no more than one walking stick (1 study, 112 participants), early mortality (1 study, 383 participants), mortality at 12 months (2 studies, 661 participants), and unplanned return to theatre (3 studies, 736 participants). No studies reported on ADL, delirium, functional status, or HRQoL. Screws versus fixed angle plates (11 studies, 2471 participants) We found low-certainty evidence of no clinically important differences between the two implant types in functional status using WOMAC (MD -3.18, 95% CI -6.35 to -0.01; 2 studies, 498 participants; range of scores from 0 to 96, lower values indicate better function), and HRQoL using EQ-5D (MD 0.03, 95% CI 0.00 to 0.06; 2 studies, 521 participants; range -0.654 (worst), 0 (dead), 1 (best)). We also found low-certainty evidence showing little or no difference between the two implant types in mortality at 12 months (RR 1.04, 95% CI 0.83 to 1.31; 7 studies, 1690 participants), and unplanned return to theatre (RR 1.10, 95% CI 0.95 to 1.26; 11 studies, 2321 participants). We found very low-certainty evidence of little or no difference between the two implant types in independent mobility (1 study, 70 participants), and early mortality (3 studies, 467 participants). No studies reported on ADL or delirium. Screws versus smooth pins (seven studies, 1119 participants) We found low-certainty evidence of no or little difference between the two implant types in mortality at 12 months (RR 1.07, 95% CI 0.85 to 1.35; 6 studies, 1005 participants; low-certainty evidence). We found very low-certainty evidence of little or no difference between the two implant types in early mortality (3 studies, 584 participants) and unplanned return to theatre (5 studies, 862 participants). No studies reported on ADL, delirium, functional status, HRQoL, or mobility. Screws or smooth pins versus fixed angle plates (15 studies, 3784 participants) In this comparison, we combined data from the first two comparison groups. We found low-certainty evidence of no or little difference between the two groups of implants in mortality at 12 months (RR 1.04, 95% CI.083 to 1.31; 7 studies, 1690 participants) and unplanned return to theatre (RR 1.02, 95% CI 0.88 to 1.18; 14 studies, 3057 participants). We found very low-certainty evidence of little or no difference between the two groups of implants in independent mobility (2 studies, 182 participants), and early mortality (4 studies, 850 participants). We found no additional evidence to support the findings for functional status or HRQoL as reported in 'Screws versus fixed angle plates'. No studies reported ADL or delirium. AUTHORS' CONCLUSIONS: There is low-certainty evidence that there may be little or no difference between screws and fixed angle plates in functional status, HRQoL, mortality at 12 months, or unplanned return to theatre; and between screws and pins in mortality at 12 months. The limited and very low-certainty evidence for the outcomes for which data were available for the smooth pins versus fixed angle plates comparison, as well as the other outcomes for which data were available for the screws and fixed angle plates, and screws and pins comparisons means we have very little confidence in the estimates of effect for these outcomes. Additional RCTs would increase the certainty of the evidence. We encourage such studies to report outcomes consistent with the core outcome set for hip fracture, including long-term quality of life indicators such as ADL and mobility.

摘要

背景:髋部骨折是一个主要的医疗保健问题,给患者、医疗体系和社会带来了巨大的挑战和负担。世界人口中老年人的比例增加意味着全球范围内髋部骨折的绝对数量正在迅速增加。大多数髋部骨折需要手术治疗。本综述评估了用于治疗囊内髋部骨折的关节保留手术中使用的内固定植入物的证据。

目的:确定不同的植入物在老年人群中治疗囊内髋部骨折的内固定方面的相对效果(益处和危害)。

检索方法:我们于 2020 年 7 月在 Cochrane 对照试验中心数据库、MEDLINE、Embase、Web of Science、Cochrane 数据库的系统评价、Epistemonikos、ProQuest 学位论文和美国国家技术信息服务中心检索了文献。我们还检索了临床试验数据库、会议论文集、检索到的文章的参考文献,并进行了回溯引文搜索。

选择标准:我们纳入了比较老年人群中囊内股骨近端骨折的内固定用光滑钉(包括带有折叠钩的钉)、螺钉或固定角度板的随机对照试验(RCT)和准 RCT。我们排除了所有或大多数骨折均由骨质疏松症以外的特定病理引起或由高能量创伤引起的研究。

数据收集和分析:两位综述作者独立评估研究纳入情况。一位综述作者提取数据并评估偏倚风险,另一位综述作者对其进行检查。我们收集了七个结局的数据:日常生活活动(ADL)、谵妄、功能状态、健康相关生活质量(HRQoL)、移动能力、死亡率(术后四个月内报告为早期死亡率,术后 12 个月报告为手术),以及因原发性手术直接或间接导致的并发症而计划外返回手术室进行治疗(如深部感染或不愈合)。我们使用 GRADE 评估这些结局的证据确定性。

主要结果:我们纳入了 38 项研究(32 项 RCT,6 项准 RCT),涉及 8585 名参与者和 8590 例囊内骨折。研究参与者的平均年龄为 60 至 84 岁;73%为女性,38%的骨折为无移位。我们在此报告四项主要比较的结果,这些比较是在不同类别的植入物之间进行的。我们因资料不充足或置信区间(CI)较宽而降低了结局的证据确定性(精确度),研究局限性(例如高或不明确的偏倚风险),以及不一致性(当我们注意到统计学异质性水平较大时)。光滑钉与固定角度板(四项研究,1313 名参与者)我们发现,两种植入物类型在独立移动能力(1 项研究,112 名参与者)、早期死亡率(1 项研究,383 名参与者)、12 个月死亡率(2 项研究,661 名参与者)和计划外返回手术室(3 项研究,736 名参与者)方面,差异可能较小或无差异,证据确定性为极低。没有研究报告 ADL、谵妄、功能状态或 HRQoL。螺钉与固定角度板(11 项研究,2471 名参与者)我们发现,两种植入物类型在功能状态(WOMAC 评分 MD-3.18,95%CI-6.35 至-0.01;2 项研究,498 名参与者;评分范围为 0 至 96,较低值表示功能更好)和 HRQoL(EQ-5D 评分 MD 0.03,95%CI 0.00 至 0.06;2 项研究,521 名参与者;范围为-0.654(最差)、0(死亡)、1(最佳))方面,差异可能较小或无差异,证据确定性为低。我们还发现,两种植入物类型在 12 个月死亡率(RR 1.04,95%CI 0.83 至 1.31;7 项研究,1690 名参与者)和计划外返回手术室(RR 1.10,95%CI 0.95 至 1.26;11 项研究,2321 名参与者)方面,差异可能较小或无差异,证据确定性为低。我们发现,两种植入物类型在独立移动能力(1 项研究,70 名参与者)和早期死亡率(3 项研究,467 名参与者)方面,差异可能较小或无差异,证据确定性为极低。没有研究报告 ADL 或谵妄。螺钉与光滑钉(七项研究,1119 名参与者)我们发现,两种植入物类型在 12 个月死亡率(RR 1.07,95%CI 0.85 至 1.35;6 项研究,1005 名参与者;低确定性证据)方面,差异可能较小或无差异。我们发现,两种植入物类型在早期死亡率(3 项研究,584 名参与者)和计划外返回手术室(5 项研究,862 名参与者)方面,差异可能较小或无差异,证据确定性为极低。没有研究报告 ADL、谵妄、功能状态、HRQoL 或移动能力。螺钉或光滑钉与固定角度板(十五项研究,3784 名参与者)在这项比较中,我们合并了前两个比较组的数据。我们发现,两种植入物类型在 12 个月死亡率(RR 1.04,95%CI.083 至 1.31;7 项研究,1690 名参与者)和计划外返回手术室(RR 1.02,95%CI 0.88 至 1.18;14 项研究,3057 名参与者)方面,差异可能较小或无差异。我们发现,两种植入物类型在独立移动能力(2 项研究,182 名参与者)和早期死亡率(4 项研究,850 名参与者)方面,差异可能较小或无差异,证据确定性为极低。我们没有发现其他证据支持报告的功能状态或 HRQoL 的结果,这些结果与“螺钉与固定角度板”中的结果一致。没有研究报告 ADL 或谵妄。

作者结论:有低确定性证据表明,螺钉和固定角度板在功能状态、HRQoL、12 个月死亡率或计划外返回手术室方面可能差异较小或无差异;在 12 个月死亡率方面,螺钉和光滑钉可能差异较小或无差异。对于我们有数据的平滑钉与固定角度板比较以及我们有数据的螺钉与固定角度板和螺钉与平滑钉比较的其他结局,其有限和极低确定性证据意味着我们对这些结局的估计效果的信心非常低。如果开展更多的 RCT,将会提高证据的确定性。我们鼓励此类研究报告髋部骨折的核心结局集一致的结局,包括 ADL 和移动能力等长期生活质量指标。

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[2]
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[3]
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[4]
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J Orthop Trauma. 2020-10

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BMC Musculoskelet Disord. 2020-3-3

[6]
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Acta Orthop. 2019-8-27

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Orthop Surg. 2019-7-23

[8]
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Eur J Orthop Surg Traumatol. 2019-10

[9]
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Acta Orthop Belg. 2018-9

[10]
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Injury. 2018-8

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