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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
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spondylolisthesis focused on measuring Pedicle screw. Free hand. Lumbar fixation

Eligibility Criteria

24 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 17, 2017
    Last Updated
    October 25, 2017
    Sponsor
    Zagazig University
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    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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