Koehne Niklas H, Locke Auston R, Schroen Christoph A, Ramey Matthew, Hausman Michael R
Department of Orthopaedic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Hand, Plastic and Reconstructive Surgery, BG Trauma Center Ludwigshafen, Heidelberg University, Heidelberg, Germany.
J Orthop. 2024 Nov 21;64:91-96. doi: 10.1016/j.jor.2024.11.014. eCollection 2025 Jun.
Despite randomized controlled trials (RCTs) largely supporting volar locking plates (VLPs) for the management of distal radius fractures (DRFs), surgeons often opt for non-invasive interventions such as casting. This study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the statistical robustness of RCTs assessing the efficacy of VLP in DRF management.
PubMed, Embase, and MEDLINE were queried for RCTs evaluating VLP versus casting for DRFs published from January 1st, 2000-June 30, 2024. FI and rFI were quantified for all dichotomous outcomes, and represent the number of event reversals required to alter statistical significance or non-significance, respectively. The FQ was then determined by dividing the FI or rFI by the sample size. A subanalysis was performed for outcomes pertaining to patient satisfaction, healing/function, and adverse events.
A total of 699 RCTs were identified in the initial literature search. 13 RCTs were eventually included in the final analysis, yielding 36 dichotomous outcomes. The median FI across these outcomes was 3 (IQR 3-5) and the median FQ was 0.037 (IQR 0.014-0.067). Among the 15 significant outcomes, the median FI was 2 (IQR 2-4) and the median FQ was 0.029 (IQR 0.013-0.055). The remaining 21 non-significant outcomes yielded a median rFI of 4 (IQR 2-5) and a median FQ of 0.042 (IQR 0.021-0.091). The most statistically fragile outcome category was patient satisfaction, with a median FI of 2 (IQR 2-3.5) and median FQ of 0.016 (IQR 0.013-0.030). Among 21 of the included outcomes (58.3 %), the number of patients lost to follow up exceeded the respective FI or rFI.
A statistical fragility analysis of VLP versus casting for DRFs demonstrated fragile outcomes, reporting a median FQ of 0.037, or 3.7 %. Statistically significant outcomes and patient satisfaction results were particularly fragile, and large losses to follow up were found to be an important contributor to RCT fragility. Although VLP is largely recommended by level I evidence, its superiority may not be as ubiquitous as argued by contemporary literature.
尽管随机对照试验（RCT）在很大程度上支持使用掌侧锁定钢板（VLP）治疗桡骨远端骨折（DRF），但外科医生通常会选择诸如石膏固定等非侵入性干预措施。本研究使用脆弱性指数（FI）、反向脆弱性指数（rFI）和脆弱性商数（FQ）来评估评估VLP治疗DRF疗效的RCT的统计稳健性。
在PubMed、Embase和MEDLINE数据库中查询2000年1月1日至2024年6月30日发表的评估VLP与石膏固定治疗DRF的RCT。对所有二分结局进行FI和rFI量化，分别代表改变统计学显著性或非显著性所需的事件逆转数。然后通过将FI或rFI除以样本量来确定FQ。对与患者满意度、愈合/功能和不良事件相关的结局进行亚组分析。
在初步文献检索中总共识别出699项RCT。最终有13项RCT纳入最终分析，产生了36个二分结局。这些结局的FI中位数为3（四分位间距3 - 5），FQ中位数为0.037（四分位间距0.014 - 0.067）。在15个显著结局中，FI中位数为2（四分位间距2 - 4），FQ中位数为0.029（四分位间距0.013 - 0.055）。其余21个非显著结局的rFI中位数为4（四分位间距2 - 5），FQ中位数为0.042（四分位间距0.021 - 0.091）。统计学上最脆弱的结局类别是患者满意度，FI中位数为2（四分位间距2 - 3.5），FQ中位数为0.016（四分位间距0.013 - 0.030）。在纳入的21个结局（58.3%）中，失访患者数量超过了各自的FI或rFI。
对VLP与石膏固定治疗DRF的统计脆弱性分析显示结局具有脆弱性，报告的FQ中位数为0.037，即3.7%。统计学显著结局和患者满意度结果尤其脆弱，并且发现大量失访是RCT脆弱性的一个重要因素。尽管一级证据在很大程度上推荐使用VLP，但其优越性可能并不像当代文献所主张的那样普遍。
