Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. The breach rate can be as high as 20-39.8% but most of the time only small number is associated with complications. Surgeons use assistive technique to avoid screw breached and improve screw placement accuracy. Investigators aim in this study to compare accuracy of pedicle screws placement using two guidance techniques are O-arm navigation the latest assistive imaging technique that uses three-dimensional (3-D) real time images to allow the surgeons follow the screw's trajectory, and standard cervical distractor screws to mark the entry point and trajectory.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
The screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to.
King Abdulaziz Medical City
Jeddah, Eastern Province, Saudi Arabia
RECRUITINGRate screws breach
Investigators will determine the rate of screws breach in the two comparison groups
Time frame: 6 months
Screw insertion time
screw insertion time in each technique which will be assessed by calculating the total time from puncture at the entry point by awl to complete all screw insertions into pedicles divided by the number of pedicle screws
Time frame: 5 hours
screws revision times
investigators will determine which group needs more screws revision
Time frame: 6 months
degree of screws breach
Investigators will determine degree of screws breach in the two comparison groups
Time frame: 6 months
Direction of the breach
investigators will ascertain direction of the breach, if it is lateral ,medial , inferior , or superior.
Time frame: 6 months
complications
the two groups will be compared in rate of neurological or vascular complications.
Time frame: Up to 24 weeks
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