Clinical trial NCT04196153: Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using O-arm Navigation VS Standard Cervical Distractor Screws
Official title: A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pedicle Screws
Surgery, Computer-Assisted/Adverse Effects
Bone Screws
Imaging, Three-Dimensional/Methods
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate screws breach
timeFrame: 6 months
measure: Screw insertion time
timeFrame: 5 hours
measure: screws revision times
timeFrame: 6 months
measure: degree of screws breach
timeFrame: 6 months
Secondary outcomes:
measure: Direction of the breach
timeFrame: 6 months
measure: complications
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City
state: Eastern Province
Study officials:
affiliation: Assistant Professor of Orthopedic, College of Medicine, KSAU-HS
name: Mohammed A Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References:
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