Twelve male volunteers with unilateral ACL injury, selected by convenient sampling among patients referred to a medical imaging center participated in this study. The number of samples was determined by priori sample-size power analysis (β = 0.20, and α = 0.5) based on the results of a previous study that measured the effect of wearing FKB on the anterior tibial translation of 15 normal subjects (
20). All subjects were diagnosed with complete isolated ACL tear via MRI and clinical examination performed by an expert orthopedic surgeon. The exclusion criteria were age above 45 and below 18, any sign of inflammation, joint effusion, injury in meniscus, collateral or posterior cruciate ligament, concomitant injuries in the lower limb, any abnormal limb characteristics, and pain during the lunge exercise. Prior to testing, all participants read and signed an informed consent form approved by the Research Ethics Committee of the University of Social Welfare and Rehabilitation Sciences.
A functional knee brace was fabricated for each participant by a professional orthotist. The brace consisted of an anterior shank shell, a posterior thigh shell (thermoformed plastic sheets), two fastening Velcro straps on each shell, and a pair of knee bars. The shank and thigh shells were made based on the tracings of the entire limb with precise measurements of the limb contours for each subject. The orthotic knee joint was a standard polycentric hyper-extension controlling joint (17K48, Otto Bock, Germany) with bars made from non-metallic materials. The metallic screws of the orthotic knee joint were also replaced by plastic ones to prevent masking of the fluoroscopic images.
The fluoroscopic images were acquired using a digital fluoroscopy system (Baccara, DMS-Apelem, France) with a detector image array of 1024 × 1024 pixels and 12 bit depth, capable of imaging at 10 frames per second. Imaging was performed by the trained staff of the radiology department of Mostafa Khomeini Hospital under the supervision of a specialized interventional radiologist (MD). Subjects wore a lead apron and thyroid shield all throughout the test session. During the test, the fluoroscopy table was positioned vertically and the subject stood on a 45cm height table, to position the knee joint as close to the intensifier as possible in a proper field of view (32 cm diameter). The subject was then asked to perform a slow lunge exercise with his injured leg positioned forward, stay stationary with the injured knee at maximum bent for a short time, and then go back to the initial standing position. The subject was asked to keep his trunk upright throughout the maneuver. Imaging started after making sure that the knee joint was in the proper position that was seen all through the test duration. A metal coin with a known radius securely attached to the subject’s leg or thigh was used to calibrate the image of each frame. Two tests were performed by each subject in non-braced and braced conditions. After application of the knee brace, the subject was allowed to walk for a couple of minutes to get used to the brace, followed by a 3-5 minutes rest before performing the experiment.
The image of each frame was exported to the AutoCAD environment (ver 2013, Autodesk Inc., Montreal, Canada) for analysis (
Figure 1). The angle between the two lines, tangent to the posterior cortexes of the femoral and tibial shafts, was measured as the flexion angle. The relative anterior-posterior configuration of the tibiofemoral joint was assessed by measuring the relative position of a fixed point on the femur with respect to a local coordinate system attached to the tibia. The femoral reference point (C in
Figure 1) was considered to be the center of a circle fitted to the posterior edge of the femoral intercondylar notch (
36). The tibial coordination system was defined with the y axis, along the long axis of the tibial shaft, i.e. the line tangent to the posterior cortex of the tibia. The line from the most anterior point of the tibial plateau (P in
Figure 1) perpendicular to the y axis was defined as the x axis, and the intersection point of the y and x axes (O in
Figure 1) as the origin of the tibial local coordination system. The difference between the x coordinates of the midpoint of OP, considered as the tibial reference point, and C in the tibial coordination system was used to indicate the relative anterior-posterior position of the tibia with respect to the femur (
36,
37). For each subject, the fluoroscopic images associated with 0°, 15°, 30°, 45° and 60° knee flexion angles were analyzed in two braced and non-braced conditions. For each frame, the radius of the calibration coin was used to determine the scale factor that was applied to measurement results.
Landmarks on the tibia and femur that were used to measure the tibiofemoral joint configuration.
The normality of the variables’ distributions was tested by 1-sample K-S test. Paired t-tests (α = 0.05) were used to compare the mean of anterior tibial translation in braced and non-braced conditions in different knee angles (5 levels: 0°, 15°, 30°, 45°, 60°) and phases of the lunge maneuver [eccentric (downward) phase and concentric (upward) phase]. The time duration of the maneuver and the peak knee flexion angle were also compared by paired t tests (α = 0.05). The reliability of the process was tested using intraclass correlation coefficient (ICC2, 2). Ten sample images were randomly chosen from the available data and two raters measured the anterior tibial translations using the methodology described above. The measurement process was repeated after a 2-week interval by each rater and the reliability was calculated by taking the average of the two measurements. All the statistical tests were performed using SPSS 17 for Windows (SPSS Inc., Chicago, IL, USA).