Quantitative measurement of lower limb mechanical alignment and coronal knee laxity in early flexion.

Background: Non-invasive quantification of lower limb alignment using navigation technology is now possible throughout knee flexion owing to software developments. We report the precision and accuracy of a non-invasive system measuring mechanical alignment of the lower limb including coronal stress testing of the knee.

Methods: Twelve cadaveric limbs were tested with a commercial invasive navigation system against the non-invasive system. Coronal mechanical femorotibial (MFT) alignment was measured with no stress, then 15 Nm varus and valgus applied moments. Measurements were recorded at 10° intervals from extension to 90° flexion. At each flexion interval, coefficient of repeatability (CR) tested precision within each system, and limits of agreement (LOA) tested agreement between the two systems. Limits for CR & LOA were set at 3° based on requirements for surgical planning and evaluation.

Results: Precision was acceptable throughout flexion in all conditions of stress using the invasive system (CR ≤ 1.9°). Precision was acceptable using the non-invasive system from extension to 50° flexion (CR ≤ 2.4°), beyond which precision was unacceptable (> 3.4°). With no coronal stress applied, agreement remained acceptable from extension to 40° (LOA ≤ 2.4°), and when 15 Nm varus or valgus stress was applied agreement was acceptable from extension to 30° (LOA ≤ 2.9°). Higher angles of knee flexion had a negative impact on precision and accuracy.

Conclusion & Clinical Relevance: The non-invasive system provides reliable quantitative data in-vitro on coronal MFT alignment and laxity in the range relevant to assessment of collateral ligament injury, pre-operative planning of arthroplasty and flexion instability following arthroplasty. In-vivo validation should be performed.