Reliability and Validity of an Innovative Device for ACL Testing: The Mobil-Aider™

Abstract

Background: Knee disorders prevalence is estimated at more than 50% in a lifetime. There are over 250,000 anterior cruciate ligament (ACL) injuries per year in the United States. There are over 175,000 ACL reconstructions annually. This study was a double-blinded design to establish the reliability and validity of a new orthopedic device to measure linear translation of the tibia on the femur (ACL testing). Methods: A Zeiss Smartzoom microscope was used as the gold standard to assess the ability of the Mobil-Aider™ to measure linear translation. Sixty blinded measures were taken with each of 6 different devices. Results: Both the intraclass correlation and the Pearson correlation were .986. The Cronbach alpha reliability analysis was 0.992. Independent 1-sample t tests were performed on the differences between the Mobil-Aider™ and Zeiss values, and were not found to be significant (P = .42); that is, they were the same. Bland–Altman plot and a linear regression revealed no propositional bias. Finally, with 360 measures over 6 devices, the power of this study was calculated to be 100%. Discussion: This data are the first step in establishing reliability and concurrent validity of a new device. As a result of the current data, the Mobil-Aider™ device is deemed a promising orthopedic tool for use in assessing the laxity of the ACL. Additional testing needs to be performed on both healthy and injured knees. Conclusions: There is potential for the Mobil-Aider™ to contribute to the assessment of ACL injuries, but additional human testing is needed.