STUDY DESIGN: Randomized clinical trial (level I evidence). OBJECTIVE: To compare the accuracy of non-navigation and Iso-C based navigation in pedicle screw fixation in thoracic spine deformities. SUMMARY OF BACKGROUND DATA: Thoracic 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. METHODS:Twenty-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. RESULTS: There 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. CONCLUSIONS: Iso-C navigation increases accuracy, and reduces surgical time and radiation in thoracic deformity correction surgeries.
RCT Entities:
STUDY DESIGN: Randomized clinical trial (level I evidence). OBJECTIVE: To compare the accuracy of non-navigation and Iso-C based navigation in pedicle screw fixation in thoracic spine deformities. SUMMARY OF BACKGROUND DATA: Thoracic 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. METHODS: Twenty-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. RESULTS: There 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. CONCLUSIONS:Iso-C navigation increases accuracy, and reduces surgical time and radiation in thoracic deformity correction surgeries.
Authors: Amer F Samdani; Mark Tantorski; Patrick J Cahill; Ashish Ranade; Stephen Koch; David H Clements; Randal R Betz; Jahangir Asghar Journal: Eur Spine J Date: 2010-12-18 Impact factor: 3.134
Authors: J-S Jarvers; S Katscher; A Franck; S Glasmacher; C Schmidt; T Blattert; C Josten Journal: Eur J Trauma Emerg Surg Date: 2011-04-01 Impact factor: 3.693
Authors: Ranjith Babu; Jong G Park; Ankit I Mehta; Tony Shan; Peter M Grossi; Christopher R Brown; William J Richardson; Robert E Isaacs; Carlos A Bagley; Maragatha Kuchibhatla; Oren N Gottfried Journal: Neurosurgery Date: 2012-11 Impact factor: 4.654