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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.
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