Arthroplasty Surgeons Differ in Their Intraoperative Soft Tissue Assessments: A Study in Human Cadavers to Quantify Surgical Decision-making in TKA.

BACKGROUND: In TKA, soft tissue balancing is assessed through manual intraoperative trialing. This assessment is a physical examination via manually applied forces at the ankle, generating varus and valgus moments at the knee while the surgeon visualizes the lateral and medial gaps at the joint line. Based on this examination, important surgical decisions are made that influence knee stability, such as choosing the polyethylene insert thickness. Yet, the applied forces and the assessed gaps in this examination represent a qualitative art that relies on each surgeon's intuition, experience, and training. Therefore, the extent of variation among surgeons in conducting this exam, in terms of applied loads and assessed gaps, is unknown. Moreover, whether variability in the applied loads yields different surgical decisions, such as choice of insert thickness, is also unclear. Thus, surgeons and developers have no basis for deciding to what extent the applied loads need to be standardized and controlled during a knee balance exam in TKA. QUESTIONS/PURPOSES: (1) Do the applied moments in soft tissue assessment differ among surgeons? (2) Do the assessed gaps in soft tissue assessment differ among surgeons? (3) Is the choice of insert thickness associated with the applied moments? METHODS: Seven independent human cadaveric nonarthritic lower extremities from pelvis to toe were acquired (including five females and two males with a mean age of 73 ± 7 years and a mean BMI of 25.8 ± 3.8 kg/m 2 ). Posterior cruciate ligament substituting (posterior stabilized) TKA was performed only on the right knees. Five fellowship-trained knee surgeons (with 24, 15, 15, 7, and 6 years of clinical experience) and one chief orthopaedic resident independently examined soft tissue balance in each knee in extension (0° of flexion), midflexion (30° of flexion), and flexion (90° of flexion) and selected a polyethylene insert based on their assessment. Pliable force sensors were wrapped around the leg to measure the loads applied by each surgeon. A three-dimensional (3D) motion capture system was used to measure knee kinematics and a dynamic analysis software was used to estimate the medial and lateral gaps. We assessed (1) whether surgeons applied different moments by comparing the mean applied moment by surgeons in extension, midflexion, and flexion using repeated measures (RM)-ANOVA (p < 0.05 was assumed significantly different); (2) whether surgeons assessed different gaps by comparing the mean medial and lateral gaps in extension, midflexion, and flexion using RM-ANOVA (p < 0.05 was assumed significantly different); and (3) whether the applied moments in extension, midflexion, and flexion were associated with the insert thickness choice using a generalized estimating equation (p < 0.05 was assumed a significant association). RESULTS: The applied moments differed among surgeons, with the largest mean differences occurring in varus in midflexion (16.5 Nm; p = 0.02) and flexion (7.9 Nm; p < 0.001). The measured gaps differed among surgeons at all flexion angles, with the largest mean difference occurring in flexion (1.1 ± 0.4 mm; p < 0.001). In all knees except one, the choice of insert thickness varied by l mm among surgeons. The choice of insert thickness was weakly associated with the applied moments in varus (ß = -0.06 ± 0.02 [95% confidence interval -0.11 to -0.01]; p = 0.03) and valgus (ß = -0.09 ± 0.03 [95% CI -0.18 to -0.01]; p= 0.03) in extension and in varus in flexion (ß = -0.11 ± 0.04 [95% CI -0.22 to 0.00]; p = 0.04). To put our findings in context, the greatest regression coefficient (ß = -0.11) indicates that for every 9-Nm increase in the applied varus moment (that is, 22 N of force applied to the foot assuming a shank length of 0.4 m), the choice of insert thickness decreased by 1 mm. CONCLUSION: In TKA soft tissue assessment in a human cadaver model, five surgeons and one chief resident applied different moments in midflexion and flexion and targeted different gaps in extension, midflexion, and flexion. A weak association between the applied moments in extension and flexion and the insert choice was observed. Our results indicate that in the manual assessment of soft tissue, changes in the applied moments of 9 and 11 Nm (22 to 27 N on the surgeons' hands) in flexion and extension, respectively, yielded at least a 1-mm change in choice of insert thickness. The choice of insert thickness may be more sensitive to the applied moments in in vivo surgery because the surgeon is allowed a greater array of choices beyond insert thickness. CLINICAL RELEVANCE: Among five arthroplasty surgeons with different levels of experience and a chief resident, subjective soft tissue assessment yielded 1 to 2 mm of variation in their choice of insert thickness. Therefore, developers of tools to standardize soft tissue assessment in TKA should consider controlling the force applied by the surgeon to better control for variations in insert selection.