Free Hand Lumbar Pedicular Screw Fixation
Primary Purpose
Lumbar Spondylolisthesis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pedicle screw fixation
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spondylolisthesis focused on measuring Pedicle screw. Free hand. Lumbar fixation
Eligibility Criteria
Inclusion Criteria:
- single level or double level degenerative spondylolisthesis
Exclusion Criteria:
- other causes of spondylolisthesis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
accuracy of pedicle screw insertion
Arm Description
postoperative CT lumbar spine axial and sagittal views.
Outcomes
Primary Outcome Measures
pedicle screw accuracy
Pedicle violation was assessed whether medial, inferior, lateral or superior using postoperative CT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03327298
Brief Title
Free Hand Lumbar Pedicular Screw Fixation
Official Title
Direct Pedicle Visualization And Disc Space Orientation As The Only Guide For Lumbar Pedicular Screw Insertion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 10, 2014 (Actual)
Primary Completion Date
June 5, 2015 (Actual)
Study Completion Date
June 5, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
At the same time the inferior and medial surfaces of the pedicle along with the exiting nerve root are clearly visualized, so all factors needed for correct pedicle screw insertion are available including the correct entry point, the mediolateral and craniocaudal orientation in addition to the visual protection provided from inside the canal to observe any medial or inferior pedicle violation.
The investigator used to insert a dissector inside the disc space as an additional guide to craniocaudal orientation of the screw which should be parallel to the disc space.
The process of pedicular screw insertion is completed as usual and the disc space is properly curetted using the suitable shavers then the prepared autologous bone graft is impacted in the disc space. The remaining screws are inserted and the rods are installed and secured as usual.
The time needed for each screw insertion was calculated. During the previous steps neither fluoroscopic guidance nor neuronavigation were used.
After completion of the previous steps, a single lateral and anteroposterior film was used to confirm the correct screw position.
The surgery is completed as usual and the patient is discharged for follow up after two weeks, during which a complementary CT scan lumbar spine is routinely performed and analyzed for the accuracy of the screw position.
Pedicle violation was assessed whether medial, inferior, lateral or superior.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylolisthesis
Keywords
Pedicle screw. Free hand. Lumbar fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
accuracy of pedicle screw insertion
Arm Type
Other
Arm Description
postoperative CT lumbar spine axial and sagittal views.
Intervention Type
Procedure
Intervention Name(s)
pedicle screw fixation
Intervention Description
One hundred forty four screws were placed in the lumbosacral pedicles of 32 patients using free hand technique depending on direct visualization of the pedicles, roots, and intervertebral disc ( IVD) after doing full laminectomy, then postoperative CT was done for evaluation of pedicle violation.
Primary Outcome Measure Information:
Title
pedicle screw accuracy
Description
Pedicle violation was assessed whether medial, inferior, lateral or superior using postoperative CT
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
single level or double level degenerative spondylolisthesis
Exclusion Criteria:
other causes of spondylolisthesis
12. IPD Sharing Statement
Plan to Share IPD
No
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Free Hand Lumbar Pedicular Screw Fixation
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