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

Area of Science:

• Orthopedic Surgery
• Sports Medicine
• Biomechanical Engineering

Background:

• Anterior cruciate ligament reconstruction (ACLR) is often augmented with lateral extra-articular tenodesis (LET) or anterolateral ligament (ALL) reconstruction.
• These augmentations aim to address anterolateral rotatory instability.
• The clinical significance of these procedures requires robust statistical validation.

Purpose of the Study:

• To assess the statistical robustness of outcomes reported in randomized controlled trials (RCTs) evaluating LET and ALL reconstruction during ACLR.
• To determine the fragility of reported outcomes using the fragility index (FI) and fragility quotient (FQ).

Main Methods:

• Systematic search of PubMed, Embase, and MEDLINE for RCTs published between 2010 and 2024.
• Inclusion of RCTs assessing LET and/or ALL reconstruction as augmentation during ACLR.
• Calculation of FI/reverse FI (rFI) and FQ for 51 reported outcomes across 17 RCTs.

Main Results:

• The median FI was 4, with a median FQ of 0.031, indicating statistically fragile outcomes.
• Statistically significant outcomes were more fragile (median FQ 0.015) than nonsignificant outcomes (median FQ 0.038).
• In 60.8% of outcomes, patient loss to follow-up exceeded the outcome's fragility index.

Conclusions:

• Outcomes reported in RCTs for LET and ALL augmentation in ACLR are statistically fragile.
• There is a need for more adequately powered RCTs to establish the true clinical significance of these anterolateral augmentation techniques.