Randomized Controlled Trials Evaluating LET and ALL for Anterolateral Rotatory Instability in ACLR Are Fragile: A Systematic Review.

Abstract

Context: 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.

Objective: 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.

Methods: 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 of evidence: Level 1.

Results: 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.

Conclusion: 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.