High continuous fragility index values amongst trials comparing anterior cruciate ligament reconstruction with and without anterolateral complex procedures: A systematic review

IF 1.6 4区医学 Q3 ORTHOPEDICS

Knee Pub Date : 2025-05-28 DOI:10.1016/j.knee.2025.05.001

Andy Deprato , Juliana Onesi , Prushoth Vivekanantha , Amit Meena , Shahbaz Malik , Darren de SA

{"title":"High continuous fragility index values amongst trials comparing anterior cruciate ligament reconstruction with and without anterolateral complex procedures: A systematic review","authors":"Andy Deprato , Juliana Onesi , Prushoth Vivekanantha , Amit Meena , Shahbaz Malik , Darren de SA","doi":"10.1016/j.knee.2025.05.001","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>This systematic review aimed to determine the statistical fragility of randomized controlled trials (RCTs) comparing anterior cruciate ligament reconstruction (ACLR) with or without anterolateral complex (ALC) procedures.</div></div><div><h3>Methods</h3><div>PubMed, MEDLINE, and EMBASE were searched from inception to April 22, 2024 for RCTs comparing ACLR with or without ALC procedures (lateral extra-articular tenodesis or anterolateral ligament reconstruction). Studies that reported ≥1 statistically significant continuous outcome, statistically significant dichotomous outcome, and/or non-significant dichotomous outcome were included. The fragility index (FI), continuous fragility index (CFI), and reverse fragility index (RFI) were calculated for these outcomes, respectively.</div></div><div><h3>Results</h3><div>20 RCTs including 2,292 patients were included (mean study size: 114.6 patients). The median FI across 21 outcomes from 11 studies was 2.0 (interquartile range [IQR], 2.0). The median CFI across 20 outcomes from seven studies was 16.9 (IQR, 227.7). The median RFI across 107 outcomes from 19 studies was 5.0 (IQR, 2.0). The number of patients lost to follow-up at the final follow-up period was more than the study-specific FI in eight (72.7%) studies, CFI in two (28.6%) studies, and RFI in 12 (63.2%) studies.</div></div><div><h3>Conclusion</h3><div>This systematic review demonstrated that RCTs comparing ACLR with or without ALC procedures have low FI and RFI values that tended to exceed loss to follow-up, demonstrating relative statistical fragility of existing literature. However, CFI values were high amongst RCTs, suggesting robustness in findings for quantitative outcomes. While fragility indices are important metrics of robustness to consider, their application in research and clinical practice should be further investigated.</div></div>","PeriodicalId":56110,"journal":{"name":"Knee","volume":"56 ","pages":"Pages 132-149"},"PeriodicalIF":1.6000,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Knee","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0968016025000948","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ORTHOPEDICS","Score":null,"Total":0}

引用次数: 0

Abstract

Background

This systematic review aimed to determine the statistical fragility of randomized controlled trials (RCTs) comparing anterior cruciate ligament reconstruction (ACLR) with or without anterolateral complex (ALC) procedures.

Methods

PubMed, MEDLINE, and EMBASE were searched from inception to April 22, 2024 for RCTs comparing ACLR with or without ALC procedures (lateral extra-articular tenodesis or anterolateral ligament reconstruction). Studies that reported ≥1 statistically significant continuous outcome, statistically significant dichotomous outcome, and/or non-significant dichotomous outcome were included. The fragility index (FI), continuous fragility index (CFI), and reverse fragility index (RFI) were calculated for these outcomes, respectively.

Results

20 RCTs including 2,292 patients were included (mean study size: 114.6 patients). The median FI across 21 outcomes from 11 studies was 2.0 (interquartile range [IQR], 2.0). The median CFI across 20 outcomes from seven studies was 16.9 (IQR, 227.7). The median RFI across 107 outcomes from 19 studies was 5.0 (IQR, 2.0). The number of patients lost to follow-up at the final follow-up period was more than the study-specific FI in eight (72.7%) studies, CFI in two (28.6%) studies, and RFI in 12 (63.2%) studies.

Conclusion

This systematic review demonstrated that RCTs comparing ACLR with or without ALC procedures have low FI and RFI values that tended to exceed loss to follow-up, demonstrating relative statistical fragility of existing literature. However, CFI values were high amongst RCTs, suggesting robustness in findings for quantitative outcomes. While fragility indices are important metrics of robustness to consider, their application in research and clinical practice should be further investigated.

查看原文本刊更多论文

在比较前交叉韧带重建有和没有前外侧复杂手术的试验中，高连续脆性指数值：一项系统回顾

本系统综述旨在确定随机对照试验（rct）比较前交叉韧带重建（ACLR）与前外侧复合体（ALC）手术的统计学脆弱性。方法检索spubmed、MEDLINE和EMBASE从成立到2024年4月22日的rct，比较ACLR是否进行了ALC手术（外侧关节外肌腱固定术或前外侧韧带重建）。报告≥1个有统计学意义的连续结局、有统计学意义的二分类结局和/或无统计学意义的二分类结局的研究被纳入。对这些结果分别计算脆弱性指数（FI）、连续脆弱性指数（CFI）和反向脆弱性指数（RFI）。结果纳入20项随机对照试验，共纳入2292例患者（平均研究规模：114.6例患者）。11项研究的21个结局的中位FI为2.0（四分位数范围[IQR]， 2.0）。来自7项研究的20个结局的中位CFI为16.9 （IQR, 227.7）。19项研究的107个结果的中位RFI为5.0 （IQR, 2.0）。在最后随访期间，8项（72.7%）研究中失去随访的患者数量超过了研究特异性FI， 2项（28.6%）研究中失去随访的患者数量超过了研究特异性FI， 12项（63.2%）研究中失去随访的患者数量超过了RFI。本系统综述表明，比较ACLR与不进行ALC手术的rct具有较低的FI和RFI值，往往超过随访损失，表明现有文献的统计脆弱性。然而，CFI值在随机对照试验中很高，表明定量结果的研究结果具有稳健性。虽然脆弱性指数是鲁棒性的重要指标，但它们在研究和临床实践中的应用应进一步研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Knee 医学-外科

CiteScore

3.80

自引率

5.30%

发文量

171

审稿时长

6 months

期刊介绍： The Knee is an international journal publishing studies on the clinical treatment and fundamental biomechanical characteristics of this joint. The aim of the journal is to provide a vehicle relevant to surgeons, biomedical engineers, imaging specialists, materials scientists, rehabilitation personnel and all those with an interest in the knee. The topics covered include, but are not limited to: • Anatomy, physiology, morphology and biochemistry; • Biomechanical studies; • Advances in the development of prosthetic, orthotic and augmentation devices; • Imaging and diagnostic techniques; • Pathology; • Trauma; • Surgery; • Rehabilitation.