A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pedicle Screws
- Sponsor
- King Abdullah International Medical Research Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Screw insertion time
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Screw insertion time
Time Frame: 5 hours
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
screws revision times
Time Frame: 6 months
investigators will determine which group needs more screws revision
degree of screws breach
Time Frame: 6 months
Investigators will determine degree of screws breach in the two comparison groups
Rate screws breach
Time Frame: 6 months
Investigators will determine the rate of screws breach in the two comparison groups
Secondary Outcomes
- complications(Up to 24 weeks)
- Direction of the breach(6 months)