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Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microdecompression
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Microdecompression, laminectomy, pain, stenosis

Eligibility Criteria

41 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients were suffered from back pain of different degrees with spinal claudication

Exclusion Criteria:

  • Smoking
  • Diabetic patients,
  • Previous spinal surgery,
  • any neuromuscular disorder like poliomyelitis, and
  • vertebral instability proved by Dynamic plain radiographs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Open

    Microscope

    Arm Description

    Open laminectomy and posterior stabilization with pedicle screws for symptomatic lumbar spine stenosis

    Microscopically done decompression of lumbar spine stenosis who are symptomatic

    Outcomes

    Primary Outcome Measures

    Oswestry disability index
    For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)
    Visual analoge score
    This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2019
    Last Updated
    October 15, 2019
    Sponsor
    Hawler Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04087694
    Brief Title
    Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis
    Official Title
    Comparative Study Between Microdecompression and Open Decompression With Posterior Stabilization for Symptomatic Lumbar Spine Stenosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 3, 2016 (Actual)
    Primary Completion Date
    October 4, 2018 (Actual)
    Study Completion Date
    October 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hawler Medical 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
    This study compare the results of 2 methods in surgical treatment of Lumbar spine stenosis.These are microdecompresssion and open decompression with posterior stabilization. 100 patients are involved in this study who divided in 2 groups.Each group was treated with one method and follow up done which showed both method are effective with better results in those patients treated with microdecomppression.
    Detailed Description
    This randomized controlled study was conducted between January 2016 and October 2018. One hundred patients were involved in this study. All these patients were suffered from radicular leg pain with MRI features of multilevel lumbar spinal stenosis and were treated by conservative treatment of medical treatment and physiotherapy without benefit for (6) months. Those patients were divided into two groups; Group A, (50) Microdecompression, and Group B, (50) patients who were treated by open wide laminectomy and posterior stabilization. Both groups of patients were followed up with ODI (Oswestry disability index) and VAS (Visual analogue score) for the back and leg pain for one year. Results: The results showed that both groups got significant improvement regarding Oswestry disability index. Regarding back pain, there was a significant improvement in both groups with better results in-group A due minimal tissues injury as the advantage of minimal invasive technique. In both groups, there were marked improvement of radicular leg pain postoperatively. Conclusions: Both Microdecompression and wide open laminectomy with posterior stabilization were effective in treatment of multilevel lumbar spinal stenosis with superior results of Microdecompression regarding less back pain postoperatively with less blood loss and soft tissue dissection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Spinal Stenosis
    Keywords
    Microdecompression, laminectomy, pain, stenosis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Open
    Arm Type
    Other
    Arm Description
    Open laminectomy and posterior stabilization with pedicle screws for symptomatic lumbar spine stenosis
    Arm Title
    Microscope
    Arm Type
    Other
    Arm Description
    Microscopically done decompression of lumbar spine stenosis who are symptomatic
    Intervention Type
    Procedure
    Intervention Name(s)
    Microdecompression
    Other Intervention Name(s)
    Open decompression with posterior fixation
    Intervention Description
    comparative surgical treatment
    Primary Outcome Measure Information:
    Title
    Oswestry disability index
    Description
    For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)
    Time Frame
    It was measured at 12 months after operation
    Title
    Visual analoge score
    Description
    This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain
    Time Frame
    It was measured at 12 months after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    41 Years
    Maximum Age & Unit of Time
    66 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients were suffered from back pain of different degrees with spinal claudication Exclusion Criteria: Smoking Diabetic patients, Previous spinal surgery, any neuromuscular disorder like poliomyelitis, and vertebral instability proved by Dynamic plain radiographs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherwan Hamawandi
    Organizational Affiliation
    Hawler medical university / college of medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    I want to share all my research with other researcher
    Citations:
    PubMed Identifier
    31827656
    Citation
    Hamawandi SA, Sulaiman II, Al-Humairi AK. Microdecompression versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis: A Randomized Controlled Trial. Pain Res Manag. 2019 Nov 7;2019:7214129. doi: 10.1155/2019/7214129. eCollection 2019.
    Results Reference
    derived

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    Microdecompression Versus Open Laminectomy and Posterior Stabilization for Multilevel Lumbar Spine Stenosis

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