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Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis

Primary Purpose

Lumbar Spinal Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
unilateral laminotomy
decompressive laminectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age:40-80 years
  2. sex:both sexes
  3. symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
  4. radiologically confirmed LSS , caused by degenerative changes
  5. canal stenosis at a maximum of 2 levels

Exclusion Criteria:

  1. were to undergo a concomitant fusion or instrumentation placement;
  2. had had previous lumbar surgeries at the same level;
  3. had spondylolisthesis of any grade or degenerative scoliosis;
  4. had evidence of instability on dynamic radiographs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    unilateral laminotomy

    decompressive laminectomy

    Arm Description

    patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression

    patients with lumbar canal stenosis who undergo decompressive laminectomy

    Outcomes

    Primary Outcome Measures

    back pain
    visual analog scale

    Secondary Outcome Measures

    neurogenic claudication pain
    distance can be walked

    Full Information

    First Posted
    December 19, 2017
    Last Updated
    January 1, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03388307
    Brief Title
    Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis
    Official Title
    Unilateral Decompression Approach for Lumbar Canal Stenosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 15, 2018 (Anticipated)
    Primary Completion Date
    November 1, 2018 (Anticipated)
    Study Completion Date
    November 15, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome.
    Detailed Description
    Lumbar stenosis is one of the common spinal pathologies; it presents with back pain, leg pain, and neurogenic claudication . Although different surgical modalities are available, the main objective of the operation is decompression of nerve roots and the spinal cord. Minimally invasive surgical procedures and microsurgical unilateral laminotomy with bilateral spinal canal decompression (ULBD) have been reported to achieve this goal . The objective of lumbar decompression is to decompress the neural elements while preserving stability and the spinous processes. The object of this study is to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ULBD) to a standard "open" laminectomy for LSS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Spinal Stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    unilateral laminotomy
    Arm Type
    Experimental
    Arm Description
    patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression
    Arm Title
    decompressive laminectomy
    Arm Type
    Experimental
    Arm Description
    patients with lumbar canal stenosis who undergo decompressive laminectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    unilateral laminotomy
    Intervention Description
    minimally invasive technique
    Intervention Type
    Procedure
    Intervention Name(s)
    decompressive laminectomy
    Intervention Description
    classic surgery
    Primary Outcome Measure Information:
    Title
    back pain
    Description
    visual analog scale
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    neurogenic claudication pain
    Description
    distance can be walked
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age:40-80 years sex:both sexes symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction. radiologically confirmed LSS , caused by degenerative changes canal stenosis at a maximum of 2 levels Exclusion Criteria: were to undergo a concomitant fusion or instrumentation placement; had had previous lumbar surgeries at the same level; had spondylolisthesis of any grade or degenerative scoliosis; had evidence of instability on dynamic radiographs.

    12. IPD Sharing Statement

    Learn more about this trial

    Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis

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