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微创外科治疗拇外翻畸形是否优于开放手术:系统评价和荟萃分析。

Does Minimally Invasive Surgery Provide Better Clinical or Radiographic Outcomes Than Open Surgery in the Treatment of Hallux Valgus Deformity? A Systematic Review and Meta-analysis.

机构信息

Department of Trauma and Orthopaedic Surgery, Division of Orthopaedics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich, University Hospital, LMU Munich, Germany.

出版信息

Clin Orthop Relat Res. 2023 Jun 1;481(6):1143-1155. doi: 10.1097/CORR.0000000000002471. Epub 2022 Nov 4.


DOI:10.1097/CORR.0000000000002471
PMID:36332131
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10194698/
Abstract

BACKGROUND: Hallux valgus is the most common foot deformity and affects 23% to 35% of the general population. More than 150 different techniques have been described for surgical correction. Recently, there has been increasing interest in the use of minimally invasive surgery to correct hallux valgus deformities. A variety of studies have been published with differing outcomes regarding minimally invasive surgery. However, most studies lack sufficient power and are small, making it difficult to draw adequate conclusions. A meta-analysis can therefore be helpful to evaluate and compare minimally invasive and open surgery. QUESTIONS/PURPOSES: We performed a systematic review and meta-analysis of randomized controlled trials and prospective controlled studies to answer the following question: Compared with open surgery, does minimally invasive surgery for hallux valgus result in (1) improved American Orthopaedic Foot and Ankle Society (AOFAS) scores and VAS scores for pain, (2) improved radiologic outcomes, (3) fewer complications, or (4) a shorter duration of surgery? METHODS: The systematic review and meta-analysis was conducted according to the guidelines of the Cochrane Handbook for Systematic Reviews of Intervention and the Preferred Reporting Items for Systematic Reviews and Meta-analyses. A search was performed in the PubMed, Embase, Scopus, CINAHL, and CENTRAL databases on May 3, 2022. Studies were eligible if they were randomized controlled or prospective controlled studies that compared minimally invasive surgery and open surgery to treat patients with hallux valgus. We defined minimally invasive surgery as surgery performed through the smallest incision required to perform the procedure accurately, with an incision length of approximately 2 cm at maximum. Open surgery, on the other hand, involves a larger incision and direct visualization of deeper structures. Seven studies (395 feet), consisting of six randomized controlled studies and one prospective comparative study, were included in the qualitative and quantitative data synthesis. There were no differences between the minimally invasive and open surgery groups regarding age, gender, or severity of hallux valgus deformity. Each included study was assessed for the risk of bias using the second version of the Cochrane tool for assessing the risk of bias in randomized trials or by using the Newcastle-Ottawa Scale for comparative studies. Most of the included studies had intermediate quality regarding the risk of bias. We excluded one study from our analysis because of its high risk of bias to avoid serious distortions in the meta-analysis. We performed a sensitivity analysis to confirm that our meta-analysis was robust by including only studies with a low risk of bias. The analyzed endpoints included the AOFAS score (range 0 to 100), where higher scores represent less pain and better function; the minimum clinically important difference on this scale was 29 points. In addition, the VAS score was analyzed, which is based on a pain rating scale (range 0 to 10), with higher scores representing greater pain. Radiologic outcomes included the hallux valgus angle, intermetatarsal angle, and distal metatarsal articular angle. Complications were qualitatively assessed and evaluated for differences. A random-effects model was used if substantial heterogeneity (I 2 > 50%) was found; otherwise, a fixed-effects model was used. RESULTS: We found no clinically important difference between minimally invasive and open surgery in terms of the AOFAS score (88 ± 7 versus 85 ± 8, respectively; mean difference 4 points [95% CI 1 to 6]; p < 0.01). There were no differences between the minimally invasive and open surgery groups in terms of VAS scores (0 ± 0 versus 0 ± 1, respectively; standardized mean difference 0 points [95% CI -1 to 0]; p = 0.08). There were no differences between the minimally invasive and open surgery groups in terms of the hallux valgus angle (12° ± 4° versus 12° ± 4°; mean difference 0 points [95% CI -2 to 2]; p = 0.76). Radiographic measurements of the intermetatarsal angle did not differ between the minimally invasive and open surgery groups (7° ± 2° versus 7° ± 2°; mean difference 0 points [95% CI -1 to 1]; p = 0.69). In addition, there were no differences between the minimally invasive and open surgery groups in terms of the distal metatarsal articular angle (7° ± 4° versus 8° ± 4°; mean difference -1 point [95% CI -4 to 2]; p = 0.28). The qualitative analysis revealed no difference in the frequency or severity of complications between the minimally invasive and the open surgery groups. The minimally invasive and open surgery groups did not differ in terms of the duration of surgery (28 ± 8 minutes versus 40 ± 10 minutes; mean difference -12 minutes [95% CI -25 to 1]; p = 0.06). CONCLUSION: This meta-analysis found that hallux valgus treated with minimally invasive surgery did not result in improved clinical or radiologic outcomes compared with open surgery. Methodologic shortcomings of the source studies in this meta-analysis likely inflated the apparent benefits of minimally invasive surgery, such that in reality it may be inferior to the traditional approach. Given the associated learning curves-during which patients may be harmed by surgeons who are gaining familiarity with a new technique-we are unable to recommend the minimally invasive approach over traditional approaches, in light of the absence of any clinically important benefits identified in this meta-analysis. Future research should ensure studies are methodologically robust using validated clinical and radiologic parameters, as well as patient-reported outcome measures, to assess the long-term outcomes of minimally invasive surgery.

摘要

背景:拇外翻是最常见的足部畸形,影响 23% 至 35%的普通人群。已经描述了超过 150 种不同的手术方法来进行矫正。最近,人们对使用微创技术来矫正拇外翻畸形越来越感兴趣。已经发表了各种研究,其结果在微创手术方面存在差异。然而,大多数研究的样本量不足且规模较小,难以得出充分的结论。因此,荟萃分析有助于评估和比较微创和开放手术。

问题/目的:我们进行了一项系统评价和荟萃分析,纳入了随机对照试验和前瞻性对照研究,以回答以下问题:与开放手术相比,微创治疗拇外翻是否(1)改善美国矫形足踝协会(AOFAS)评分和疼痛视觉模拟量表(VAS)评分,(2)改善影像学结果,(3)减少并发症,或(4)手术时间更短?

方法:根据 Cochrane 干预系统评价手册和系统评价和荟萃分析的首选报告项目的指南进行了系统评价和荟萃分析。于 2022 年 5 月 3 日在 PubMed、Embase、Scopus、CINAHL 和 CENTRAL 数据库中进行了搜索。如果研究比较了微创和开放手术治疗拇外翻患者,且为随机对照或前瞻性对照研究,则认为该研究符合纳入标准。我们将微创手术定义为通过进行准确手术所需的最小切口进行的手术,最大切口长度约为 2 厘米。另一方面,开放手术涉及更大的切口和对更深层结构的直接可视化。共有 7 项研究(395 只脚)纳入了定性和定量数据分析,包括 6 项随机对照研究和 1 项前瞻性对照研究。微创组和开放组在年龄、性别或拇外翻畸形严重程度方面无差异。每个纳入的研究均使用 Cochrane 工具评估随机对照试验的偏倚风险或使用纽卡斯尔-渥太华量表评估比较研究的偏倚风险。大多数纳入的研究在偏倚风险方面具有中等质量。由于高偏倚风险,我们排除了一项研究,以避免荟萃分析中出现严重扭曲。我们通过纳入仅具有低偏倚风险的研究进行敏感性分析,以确认我们的荟萃分析是稳健的。分析的终点包括 AOFAS 评分(范围 0 至 100),其中较高的分数代表较少的疼痛和更好的功能;该量表的最小临床重要差异为 29 分。此外,还分析了 VAS 评分,该评分基于疼痛评分量表(范围 0 至 10),其中较高的分数代表更严重的疼痛。影像学结果包括拇外翻角、跖骨间角和远端跖骨关节角。并发症定性评估,并评估差异。如果发现存在显著异质性(I 2 > 50%),则使用随机效应模型;否则,使用固定效应模型。

结果:我们发现微创和开放手术在 AOFAS 评分方面没有临床意义上的差异(分别为 88 ± 7 和 85 ± 8,平均差异 4 分[95%CI 1 至 6];p < 0.01)。微创组和开放组在 VAS 评分方面也没有差异(分别为 0 ± 0 和 0 ± 1,标准化均数差 0 分[95%CI -1 至 0];p = 0.08)。微创组和开放组的拇外翻角也没有差异(分别为 12° ± 4°和 12° ± 4°;平均差异 0 点[95%CI -2 至 2];p = 0.76)。微创组和开放组的跖骨间角的影像学测量也没有差异(分别为 7° ± 2°和 7° ± 2°;平均差异 0 点[95%CI -1 至 1];p = 0.69)。此外,微创组和开放组的远端跖骨关节角也没有差异(分别为 7° ± 4°和 8° ± 4°;平均差异 -1 点[95%CI -4 至 2];p = 0.28)。定性分析显示,微创组和开放组的并发症发生率和严重程度没有差异。微创组和开放组的手术时间也没有差异(分别为 28 ± 8 分钟和 40 ± 10 分钟;平均差异 -12 分钟[95%CI -25 至 1];p = 0.06)。

结论:这项荟萃分析发现,与开放手术相比,微创治疗拇外翻并未改善临床或影像学结果。本荟萃分析中纳入研究的方法学缺陷可能夸大了微创手术的明显益处,以至于实际上它可能不如传统方法。鉴于在外科医生熟悉新技术的过程中(在此期间,患者可能会因医生的不熟练而受到伤害)可能会对患者造成伤害,我们无法推荐微创方法优于传统方法,因为本荟萃分析中没有发现任何有临床意义的益处。未来的研究应确保使用经过验证的临床和影像学参数以及患者报告的结果衡量标准来进行研究,以评估微创手术的长期结果。

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