Bone Screws, Imaging, Three-Dimensional/Methods, Pedicle Screws, Surgery, Computer-Assisted/Adverse Effects
Conditions
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.
Interventions
PROCEDUREPedicle screws instrumentation
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.
Sponsors
King Abdullah International Medical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate screws breach | 6 months | Investigators will determine the rate of screws breach in the two comparison groups |
| Screw insertion time | 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 | 6 months | investigators will determine which group needs more screws revision |
| degree of screws breach | 6 months | Investigators will determine degree of screws breach in the two comparison groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Direction of the breach | 6 months | investigators will ascertain direction of the breach, if it is lateral ,medial , inferior , or superior. |
| complications | Up to 24 weeks | the two groups will be compared in rate of neurological or vascular complications. |
Countries
Saudi Arabia
Contacts
Primary ContactMuath M Alswat, MD
Outcome results
None listed