The Reliability of the GNRB® Knee Arthrometer in Measuring ACL Stiffness and Laxity: Implications for Clinical Use and Clinical Trial Design.

Background: Stability of the knee is dependent on multiple factors including integrity of the anterior cruciate ligament (ACL). Greater knee joint laxity appears to negatively affect dynamic joint function and therefore reliable and valid measures of ACL stiffness and laxity are clinically valuable. Purpose: The aim of this study was to investigate the reliability of the GENOUROB, (GNRB®) knee arthrometer device in measuring both stiffness and laxity of the ACL, and to provide information on sample size calculation for future clinical trials. Study Design: Cross-sectional test-retest study. Method: Twelve healthy student participants (age 24-30 years; 6 females and 6 males) completed testing on two different testing dates. Anterior tibial translation and stiffness were measured using the GNRB® device at forces of 134N and 200N. Reliability analyses were performed using intraclass correlation coefficients (ICC). SEM, MDC, and sample size calculations were also determined. Results: Average anterior tibial displacements of 3.63mm and 5.32mm were found for 134N and 200N of force respectively. ICC values for intra-rater, inter-rater, and test-retest reliability were similar across measures of anterior tibial translation and stiffness, ranging from .72 to .83 (95% CI: .54 to .90). The standard error of measurement (SEM) for anterior tibial stiffness ranged from 3.47 mm/N to 3.76 mm/N. Minimal detectable change (MDC) for test-retest anterior tibial stiffness was 9.6 mm/N. Sample sizes for crossover and parallel design studies were determined. Conclusion: ACL laxity and stiffness measures were found to be reliably obtainable using the GNRB® knee arthrometer under the strict control of the individual's alignment to the device and patellar pad forces. Reliable laxity and stiffness values may assist practitioners in clinical reasoning and the development of individualized ACL rehabilitation programs. Additionally, the sample size calculations presented may aid in future research design. Level of Evidence: 3.