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ACCURACY OF ORTELIUS800 TM FOR RADIATION-FREE ASSESSMENT OF COBB ANGLE



Abstract

Introduction: Accurate and quantitative measurements of the spine are essential for deformity diagnosis and assessment of curve progression. There is much concern related to the multiple exposures to ionizing radiation associated with the Cobb method of radiographic measurement, currently the standard procedure for diagnosis and follow-up of the progression of scoliosis. In addition, the Cobb method relies on two-dimensional analysis of a three-dimensional deformity. The Ortelius800TM aims to provide a radiation-free method for scoliosis assessment in three planes (coronal, sagittal, apical) with simultaneous automatic calculation of the Cobb angle in both coronal and sagittal views. This new device is based on direct measurement of the position of the tips of the spinous processes in space. A low intensity electromagnetic field records the spatial position of a sensor attached to the examiner’s finger while palpating the patient’s spinous processes. This study investigates the correlation of spinal deformity measurements with Ortelius800TM radiation-free system as compared to standard radiographic measured Cobb angles in order to assess Ortelius800TM clinical value while enabling a significant reduction of x-ray exposure.

Methods: 124 patients diagnosed with Adolescent Idiopathic Scoliosis (AIS) from four different medical centers were measured with the Ortelius800TM system using the same standard protocol. The entire process required an average of 2 minutes. The Ortelius800TM measurements were correlated with the standard Cobb angle as measured on routine standing coronal and sagittal radiographs. The Pearson correlation coefficient was calculated for matched pair measurements. The mean difference and the absolute mean difference between measurements with the two methods was estimated.

Results: Standing full-spine coronal radiographs were obtained for each patient. Radiograph analysis for these 124 patients revealed 249 deformity measurements. The deformity measurements were comprised of 142 thoracic curves with a mean of 18.3° and 107 lumbar curves with a mean of 17.4°. Lateral radiographs were obtained from 38 patients with a mean of 36.1°. Correlation between Cobb angles measured manually on standard erect posteroanterior radiographs and those calculated by this new technique showed an absolute difference between the measurements to be significantly less than +\−5° for coronal measurements and significantly less than +\−6° for sagittal measurements indicating good correlation between the two methods.

Pearson’s correlation coefficient between deformity angles obtained by the two methods was highly significant (0.86) with a P value < 0.0001. The measurements from four independent sites were not significantly different.

Discussion: The results reveal good correlation between the two measuring methods in both coronal and sagittal views. We propose the Ortelius800TM as a clinical tool for the routine follow-up measurements of AIS patients, thus enabling a significant reduction of radiation exposure.

Correspondence should be addressed to Dr Owen Williamson, Editorial Secretary, Spine Society of Australia, 25 Erin Street, Richmond, Victoria 3121, Australia.