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核心减压术治疗非创伤性股骨头坏死中生物增强的疗效缺乏确凿证据:系统评价。

Lack of Conclusive Evidence of the Benefit of Biologic Augmentation in Core Decompression for Nontraumatic Osteonecrosis of the Femoral Head: A Systematic Review.

机构信息

Department of Orthopaedics, Balgrist University Hospital, Zurich, Switzerland.

Department of Chiropractic Medicine, Faculty of Medicine, Balgrist University Hospital and University of Zurich, Zurich, Switzerland; Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.

出版信息

Arthroscopy. 2021 Dec;37(12):3537-3551.e3. doi: 10.1016/j.arthro.2021.04.062. Epub 2021 May 5.

DOI:10.1016/j.arthro.2021.04.062
PMID:33964392
Abstract

PURPOSE

To assess whether biologic augmentation in addition to core decompression (CD), compared with CD alone, improves clinical and radiographic outcomes in the treatment of nontraumatic osteonecrosis of the femoral head (ONFH). Our hypothesis was that biologic augmentation would reduce the progression of osteonecrosis and therefore also the rate of conversion to total hip arthroplasty (THA).

METHODS

A systematic review was performed in accordance with the Preferred Reporting Items of Systematic Reviews and Meta-analysis (PRISMA) statement. Six databases were searched: Central, MEDLINE, Embase, Scopus, AMED, and Web of Science. Studies comparing outcomes of CD versus CD plus biologic augmentation (with or without structural augmentation), with a reported minimum level of evidence of III and ≥24 months of follow-up, were eligible. Procedural success was conceptualized as (1) avoidance of conversion to THA and (2) absence of radiographic disease progression. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal checklists. A quantitative analysis of heterogeneity was undertaken.

RESULTS

We included studies reporting on 560 hips in 484 patients. Biologic augmentation consisted of bone marrow stem cells in 10 studies, bone morphogenic protein in 2, and platelet-rich plasma in 1. Three studies used additional structural augmentation. The median maximum follow-up time was 45 months. Only 4 studies reported improvement in all clinical scores in the augmentation group. Seven studies observed a reduction in the rate of radiographic progression, and only 5 found reduced rates of conversion to THA when using augmentation. A high risk of bias and marked heterogeneity was found, with uncertainty about the study designs implemented, analytical approaches, and quality of reporting.

CONCLUSION

Current evidence is inconclusive regarding the benefit of biologic augmentation in CD for nontraumatic ONFH, because of inconsistent results with substantial heterogeneity and high risk of bias.

LEVEL OF EVIDENCE

III, systematic review of level I, II, and III studies.

摘要

目的

评估在核心减压术(CD)基础上联合生物增强治疗非创伤性股骨头坏死(ONFH)与单纯 CD 相比是否能改善临床和影像学结果。我们的假设是生物增强会减缓骨坏死的进展,从而降低转换为全髋关节置换术(THA)的发生率。

方法

按照系统评价和荟萃分析首选报告项目(PRISMA)声明进行系统评价。共检索了 6 个数据库:CENTRAL、MEDLINE、Embase、Scopus、AMED 和 Web of Science。纳入比较 CD 与 CD 联合生物增强(有或无结构增强)治疗结果的研究,报告的最低证据水平为 III 级,随访时间≥24 个月。将手术成功定义为(1)避免转换为 THA 和(2)无影像学疾病进展。使用 Joanna Briggs 研究所批判性评价清单评估偏倚风险。进行了异质性的定量分析。

结果

共纳入了 484 例患者的 560 髋的研究报告。生物增强包括 10 项研究中的骨髓干细胞、2 项研究中的骨形态发生蛋白和 1 项研究中的富含血小板的血浆。3 项研究使用了额外的结构性增强。中位数最长随访时间为 45 个月。只有 4 项研究报告增强组所有临床评分均有改善。7 项研究观察到影像学进展率降低,只有 5 项研究发现使用增强时转换为 THA 的比率降低。存在高偏倚风险和显著的异质性,对实施的研究设计、分析方法和报告质量存在不确定性。

结论

由于结果不一致且存在很大的异质性和高偏倚风险,目前关于非创伤性 ONFH 在 CD 基础上联合生物增强的益处的证据尚无定论。

证据等级

III,对 I、II 和 III 级研究的系统评价。

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