Yendluri Avanish, Gonzalez Christopher, Koehne Niklas H, Locke Auston R, Cuadros Adriano, Kantrowitz David E, Bienstock Dennis M, Alaia Michael J, Waterman Brian R, Li Xinning, Parisien Robert L
Department of Orthopaedic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Orthopaedic Surgery, Boston University School of Medicine, Boston, MA, USA.
Sports Health. 2025 Aug 6:19417381251360013. doi: 10.1177/19417381251360013.
Lateral extra-articular tenodesis (LET) and anterolateral ligament (ALL) reconstruction have been adopted by some surgeons as augmentations during anterior cruciate ligament reconstruction (ACLR) to improve anterolateral rotatory instability.
The objective of this study was to assess the statistical robustness of outcomes reported in randomized controlled trials (RCTs) assessing the clinical significance of LET and ALL reconstruction in ACLR.
PubMed, Embase, and MEDLINE were systematically searched. RCTs published January 1, 2010 to December 31, 2024 assessing LET and ALL reconstruction during ACLR were included. Fragility index (FI) or reverse FI (rFI) was calculated for each outcome, representing the number of event reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The fragility quotient (FQ) was determined by dividing the FI or rFI by sample size.
Level 1.
Of 112 RCTs screened for inclusion, 17 were included for analysis, resulting in 51 total outcomes. The median FI across the 51 outcomes was 4 [interquartile range (IQR), 2-7] with an associated median FQ of 0.031 (IQR, 0.014-0.049). Statistically significant outcomes were more fragile (median FI, 3.5; median FQ, 0.015) than statistically nonsignificant outcomes (median rFI, 5; median FQ, 0.038). In 60.8% of all outcomes (31 of 51), the number of patients lost to follow-up was greater than the outcome's respective FI or rFI. In the 7 RCTs assessing LET, the median FQ was 0.015 (IQR, 0.012-0.042) across 23 outcomes. In the 10 RCTs assessing ALL, the median FQ was 0.035 (IQR, 0.019-0.051) across 28 outcomes. Graft failure, pivot shift, and Lachman/anterior laxity were the most common outcome categories reported, with median FQs of 0.017, 0.035, and 0.048, respectively.
Outcomes reported in RCTs for LET and ALL reconstruction as augments of ACLR are statistically fragile, emphasizing the need for additional robust and adequately powered RCTs to better understand the impact of anterolateral augmentation on ACLR outcomes.
一些外科医生在进行前交叉韧带重建（ACLR）时采用外侧关节外肌腱固定术（LET）和前外侧韧带（ALL）重建术作为增强手术，以改善前外侧旋转不稳定。
本研究的目的是评估在评估LET和ALL重建在ACLR中的临床意义的随机对照试验（RCT）中报告的结果的统计稳健性。
系统检索了PubMed、Embase和MEDLINE。纳入2010年1月1日至2024年12月31日发表的评估ACLR期间LET和ALL重建的RCT。计算每个结果的脆弱性指数（FI）或反向脆弱性指数（rFI），分别代表改变显著和非显著结果的统计显著性所需的事件逆转数。脆弱性商数（FQ）通过将FI或rFI除以样本量来确定。
1级。
在筛选纳入的112项RCT中，17项被纳入分析，共产生51个结果。51个结果的中位数FI为4[四分位间距（IQR），2 - 7]，相关的中位数FQ为0.031（IQR，0.014 - 0.049）。具有统计学显著性的结果比无统计学显著性的结果更脆弱（中位数FI，3.5；中位数FQ，0.015）（中位数rFI，5；中位数FQ，0.038）。在所有结果的60.8%（51个中的31个）中，失访患者数量大于结果各自的FI或rFI。在评估LET的7项RCT中，23个结果的中位数FQ为0.015（IQR，0.012 - 0.042）。在评估ALL的10项RCT中，28个结果的中位数FQ为0.035（IQR，0.019 - 0.051）。移植物失败、轴移和Lachman试验/前侧松弛是报告的最常见结果类别，中位数FQ分别为0.017、0.035和0.048。
RCT中报告的作为ACLR增强术的LET和ALL重建的结果在统计学上是脆弱的，强调需要更多有力且有足够样本量的RCT来更好地了解前外侧增强对ACLR结果的影响。
