• Spine · Jan 2007

    Randomized Controlled Trial

    Randomized clinical study to compare the accuracy of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries.

    • S Rajasekaran, S Vidyadhara, Perumal Ramesh, and Ajoy P Shetty.
    • Department of Orthopaedics and Spine Surgery, Ganga Hospital, Coimbatore, Tamil Nadu, India. sr@gangahospital.com
    • Spine. 2007 Jan 15;32(2):E56-64.

    Study DesignRandomized clinical trial (level I evidence).ObjectiveTo compare the accuracy of non-navigation and Iso-C based navigation in pedicle screw fixation in thoracic spine deformities.Summary Of Background DataThoracic pedicle screw insertion for spinal deformity correction can be associated with increased pedicle breaches. Iso-C based navigation has been reported to improve the accuracy of pedicle screw placement, but its use in the presence of deformity has not been reported.MethodsTwenty-seven patients with scoliosis and 6 patients with kyphosis had a total of 478 thoracic pedicle screws. The average Cobb angle was 58.4 degrees +/- 8 degrees (range 50 degrees -80 degrees), and the mean kyphotic angle was 54.6 degrees +/- 4 degrees (range 51 degrees -76 degrees). By random allocation, 17 patients had screw insertion under navigation (242 screws) and 16 under fluoroscopic control (236 screws). The 2 groups were compared for accuracy of screw placement, time for screw insertion, and the number of times the C-arm had to be brought into the field. Two independent blinded observers determined accuracy using postoperative computed tomography assessments.ResultsThere were 54 (23%) pedicle breaches in the non-navigation group as compared to only 5 (2%) in the navigation group (P < 0.001). Thirty-eight screws (16%) in the non-navigation group had penetrated the anterior or lateral cortex compared to 2 screws (0.8%) in the navigation group. Average screw insertion time in the non-navigation group was 4.61 +/- 1.05 minutes (range 1.8-6.5) compared to 2.37 +/- 0.72 minutes (range 1.16-4.5) in navigation group (P < 0.01). The C-arm had to be moved into the operation field on an average of 1.5 +/- 0.25 times (range 1-3) per screw. With single screening data, an average of 11.4 pedicles (range 9-14) could be visualized without necessity to bring the C-arm into operating field again.ConclusionsIso-C navigation increases accuracy, and reduces surgical time and radiation in thoracic deformity correction surgeries.

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