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

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.