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Clinical Trials/NCT03327298
NCT03327298CompletedNot Applicable

Direct Pedicle Visualization And Disc Space Orientation As The Only Guide For Lumbar Pedicular Screw Insertion

Zagazig University0 sites32 target enrollmentStarted: May 10, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Primary Endpoint
pedicle screw accuracy

Study Overview

Brief Summary

Background: Different methods for lumbar pedicular screw insertion have been advocated, however each technique has its cons and pros. Due to limited resources for O-Arm and navigation in our locality, the investigator was enforced to use the surgical skills to minimize the need for such advanced modalities.

Aim of the study: Is to clarify the benefits of the use of free hand technique using direct visualization of the pedicles and disc space as the only guide for pedicular screw insertion using postoperative CT for evaluation of the accuracy of pedicle screw insertion.

Patients and methods: One hundred and forty four screws were inserted in 32 patients using direct pedicle visualization and disc space orientation as a single intraoperative reference guide. The study was conducted in Zagazig University Hospitals from May, 2014 to June, 2015. CT was done for all patients as a direct postoperative evaluation tool.

Detailed Description

Patients and methods: This study was conducted in Zagazig University Hospitals in the period from May 2014 to June 2015 after approval from the Zagazig University Institutional Review Board (Zu-IRB). All patients were subjected to complete history talking, clinical evaluation and adequate radiological and laboratory investigations.

The radiological studies included plain X-Ray lumbosacral spine, anteroposterior, lateral neutral, and lateral dynamic views (lateral with flexion and lateral with extension), MRI lumbosacral spine sagittal and axial views, and in some cases CT lumbosacral spine with sagittal reconstruction. All these modalities give us a good idea about both soft tissue and bony pathology in the area of interest. Selection of the patients for surgery was based on clinicoradiologic items.

All the cases of pedicular screw insertion were preceded by full laminectomy with discectomy for interbody fusion. In all cases the medial and inferior aspects of the pedicle are clearly visualized, so selection of the entry point and direct observation of medial and inferior pedicle violation are two main advantages of this technique. On the other hand after discectomy the disc space with the two parallel endplates are available for use as a guide for screw craniocaudal angulation.

After the removal of the whole lamina with its inferior articular processes and removal of fibrocartilagenous tissues overlying the exiting roots and removal of the intervertebral disc, the anatomy of the pedicle and its relation to the exiting roots is clearly evident.

Starting pedicular screw insertion, part of the cortical bone at the inferolateral edge of the superior facet is removed. This entry point lies exactly along the transverse plane passing through the middle of the corresponding transverse process.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
24 Years to 73 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • single level or double level degenerative spondylolisthesis

Exclusion Criteria

  • other causes of spondylolisthesis

Arms & Interventions

accuracy of pedicle screw insertion

Other

postoperative CT lumbar spine axial and sagittal views.

Intervention: pedicle screw fixation (Procedure)

Outcomes

Primary Outcomes

pedicle screw accuracy

Time Frame: 2 weeks

Pedicle violation was assessed whether medial, inferior, lateral or superior using postoperative CT

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Hosni Salama

Assistant professor

Zagazig University

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