How statistically fragile are randomized controlled trials comparing quadriceps tendon autografts with hamstring or bone-patellar tendon-bone autografts in anterior cruciate ligament reconstruction?

IF 5 2区医学 Q1 ORTHOPEDICS Knee Surgery, Sports Traumatology, Arthroscopy Pub Date : 2024-11-04 DOI:10.1002/ksa.12535

Joshua Dworsky-Fried, Luca Bernardini, Prushoth Vivekanantha, Lauren Gyemi, Amit Meena, Sachin Tapasvi, Christian Fink, Darren de SA

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Abstract

Purpose

To determine the statistical fragility of randomized controlled trials (RCTs) which compare the use of quadriceps tendon (QT) autografts to either hamstring tendon (HT) or bone-patellar tendon-bone (BPTB) autografts in anterior cruciate ligament reconstruction (ACLR).

Methods

A search was conducted across PubMed, MEDLINE and EMBASE databases for RCTs comparing QT autografts to HT or BPTB autografts in ACLR from inception to 21 April 2024. Studies that reported ≥1 statistically significant continuous outcome, statistically significant dichotomous outcome and/or nonsignificant dichotomous outcome were included for analysis. The fragility index (FI), continuous fragility index (CFI) and reverse fragility index (RFI) were calculated for significant dichotomous outcomes, significant continuous outcomes and nonsignificant dichotomous outcomes, respectively.

Results

A total of 11 RCTs comprising 716 patients were included. The mean sample size was 65.8 patients. The median FI among nine outcomes from four studies was 1.0 (interquartile range [IQR], 0.5; 95% confidence interval [CI], 0.6–1.4; range 0.5–1.5). The number of patients lost to follow-up at the final follow-up period was more than the study-specific FI in three (75%) studies. The median CFI among 30 outcomes from six studies was 4.9 (IQR, 10.1, 95% CI, 3.9–8.2; range 0–18.2). The number of patients lost to follow-up at the final follow-up period was more than the study-specific CFI in four (66.7%) studies. The median RFI among 10 outcomes from five studies was 5.0 (IQR, 3.5; 95% CI, 3.4–6.6; range 1.0–9.0). The number of patients lost to follow-up at the final follow-up period was more than the study-specific RFI in four (80%) studies.

Conclusion

This systematic review revealed that regardless of the metric used, RCTs comparing QT autografts to HT or BPTB autograft options in ACLR are statistically fragile. While the indices of statistical fragility evaluated in this study are important metrics of robustness to consider, their application in research and clinical practice needs to be further elucidated.

Level of Evidence

Level I.

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在前交叉韧带重建中，将股四头肌腱自体移植物与腘绳肌腱或骨-髌腱-骨自体移植物进行比较的随机对照试验在统计学上有多脆弱？

目的：比较在前交叉韧带重建（ACLR）中使用股四头肌腱（QT）自体移植物与腘绳肌腱（HT）或骨-髌腱-骨（BPTB）自体移植物的随机对照试验（RCT），确定其统计易损性：方法：在 PubMed、MEDLINE 和 EMBASE 数据库中检索了从开始到 2024 年 4 月 21 日期间在 ACLR 中比较 QT 自体移植物与 HT 或 BPTB 自体移植物的 RCT。纳入分析的研究包括报告了≥1个有统计学意义的连续结果、有统计学意义的二分结果和/或无意义的二分结果。对显著的二分结果、显著的连续结果和不显著的二分结果分别计算脆性指数（FI）、连续脆性指数（CFI）和反向脆性指数（RFI）：结果：共纳入了 11 项研究，716 名患者。平均样本量为 65.8 名患者。四项研究中九项结果的中位 FI 为 1.0（四分位数间距 [IQR]，0.5；95% 置信区间 [CI]，0.6-1.4；范围 0.5-1.5）。在三项（75%）研究中，最终随访期失去随访的患者人数超过了特定研究的 FI。六项研究的 30 项结果的 CFI 中位数为 4.9（IQR，10.1，95% CI，3.9-8.2；范围 0-18.2）。有四项研究（66.7%）的最终随访期失去随访的患者人数超过了特定研究的 CFI。五项研究的 10 项结果的 RFI 中位数为 5.0（IQR，3.5；95% CI，3.4-6.6；范围 1.0-9.0）。在四项（80%）研究中，最终随访期失去随访的患者人数超过了特定研究的 RFI：本系统综述显示，无论使用何种指标，在前交叉韧带置换术中将 QT 自体移植物与 HT 或 BPTB 自体移植物进行比较的 RCT 在统计学上都很脆弱。虽然本研究中评估的统计脆性指数是衡量稳健性的重要指标，但它们在研究和临床实践中的应用还需要进一步阐明：证据等级：一级。

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来源期刊

Knee Surgery, Sports Traumatology, Arthroscopy 医学-外科

CiteScore

8.10

自引率

18.40%

发文量

418

审稿时长

2 months

期刊介绍： Few other areas of orthopedic surgery and traumatology have undergone such a dramatic evolution in the last 10 years as knee surgery, arthroscopy and sports traumatology. Ranked among the top 33% of journals in both Orthopedics and Sports Sciences, the goal of this European journal is to publish papers about innovative knee surgery, sports trauma surgery and arthroscopy. Each issue features a series of peer-reviewed articles that deal with diagnosis and management and with basic research. Each issue also contains at least one review article about an important clinical problem. Case presentations or short notes about technical innovations are also accepted for publication. The articles cover all aspects of knee surgery and all types of sports trauma; in addition, epidemiology, diagnosis, treatment and prevention, and all types of arthroscopy (not only the knee but also the shoulder, elbow, wrist, hip, ankle, etc.) are addressed. Articles on new diagnostic techniques such as MRI and ultrasound and high-quality articles about the biomechanics of joints, muscles and tendons are included. Although this is largely a clinical journal, it is also open to basic research with clinical relevance. Because the journal is supported by a distinguished European Editorial Board, assisted by an international Advisory Board, you can be assured that the journal maintains the highest standards. Official Clinical Journal of the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA).