Challenge accepted: Description of an ongoing NIH-funded randomized clinical trial to compare anatomic single-bundle versus anatomic double-bundle acl reconstruction

摘要

We recently read with great interest the editorial entitled "A Modest Proposal for a Clinical Trial on Single-Bundle Versus Double-Bundle Anterior Cruciate Ligament Reconstruction" by D'Agostino et al.1 in the March 2012 issue of Arthroscopy. We agree wholeheartedly with the authors' call for large, high-quality randomized controlled trials to compare the effectiveness of single- versus double-bundle anterior cruciate ligament (ACL) reconstruction. They accurately outlined the requirements for such studies, including well-defined subject inclusion and exclusion criteria, random assignment after final subject eligibility has been determined, blinding of the subjects as well as individuals responsible for assessing outcomes and data analysis, use of reliable and accurate patient-relevant outcome measures, and sufficiently long follow-up with minimal subjects lost to follow-up.