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

Not Applicable

• Conditions: Surgery, Computer-Assisted/Adverse Effects; Pedicle Screws; Imaging, Three-Dimensional/Methods; Bone Screws
• Interventions: Procedure: Pedicle screws instrumentation

• Registration Number: NCT04196153
• Lead Sponsor: King Abdullah International Medical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2019-12-07
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-07
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuronavigation / O-arm group	Pedicle screws instrumentation	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.
Cervical distractor screws group	Pedicle screws instrumentation	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.

Primary Outcome Measures

Name	Time	Method
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
Rate screws breach	6 months	Investigators will determine the rate of screws breach in the two comparison groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King Abdulaziz Medical City; 🇸🇦 Jeddah, Eastern Province, Saudi Arabia