Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using O-arm Navigation VS Standard Cervical Distractor Screws

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws

Conditions
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Pedicle Screws, Surgery, Computer-Assisted/Adverse Effects, Bone Screws, Imaging, Three-Dimensional/Methods

Intervention / Treatment
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* Procedure: Pedicle screws instrumentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who need a thoracolumbar spine surgery that require pedicle screw insertion. Exclusion Criteria: Patients whose surgeries in cervical spine Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neuronavigation / O-arm group<br>Under neural navigation with the use of intraoperative three dimensional imaging quality O-arm , pedicle screws inserted at the thoraolumbar/lumbar spine after insertion of the reference frame at the spinous process above or below the level of instrumentation followed by O-Arm imaging and uploading the images to the stelth navigation system and pedicle tract identification using instrumented tools guided by the Navigation polyaxial screws is inserted. | Procedure: Pedicle screws instrumentation<br>* 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.<br>|
| Active Comparator: Cervical distractor screws group<br>pedicle screws inserted using marker screws after posterior exposure of thoracolumbar /lumbar spine by either open midline posterior exposure or minimal invasive posterior wiltse style exposure with expandable tubular retractor, anatomical landmark for insertion of pedical screws identified and followed by inserting of a cervical distraction screw size 3 / 12 mm as a stable marker using high speed drill. C-arm floro is used to take antroposterior and lateral view to confirm the position of the marker screws at this stage.free hand technique supported by the images provided to cannulate the pedicle with the use of information on the images taken for all the marker screws simultaneously. | Procedure: Pedicle screws instrumentation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate screws breach | Investigators will determine the rate of screws breach in the two comparison groups | 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 | 5 hours | 
| screws revision times | investigators will determine which group needs more screws revision | 6 months | 
| degree of screws breach | Investigators will determine degree of screws breach in the two comparison groups | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direction of the breach | investigators will ascertain direction of the breach, if it is lateral ,medial , inferior , or superior. | 6 months | 
| complications | the two groups will be compared in rate of neurological or vascular complications. | Up to 24 weeks |