Minimal Invasive Surgery Versus Interlaminar Decompression in Lumbar Canal Stenosis
Primary Purpose
Lumbar Spinal Stenosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
minimally invasive surgery
conventional open surgery
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring minimally invasive surgery, interlaminar decompression
Eligibility Criteria
Inclusion Criteria:
- all patient with lumbar canal stenosis From 18_70 years old
Exclusion Criteria:
- instability Infection Tumours of vertebrae
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group A
group B
Arm Description
randomly allocated
randomly allocated
Outcomes
Primary Outcome Measures
Functional outcome
Change of Oswestry disability index (ODI) is being assessed to compare the pre and post operative values.
This outcome measure is designed to assess function in activities of daily living for those with acute or chronic back pain.
The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).
back pain and lower limb pain
Change of visual analogue scale (VAS) is being assessed to compare the pre and post operative values. VAS is a continuous scale comprised of a horizontal line, usually 10 centimeters in length. For pain intensity, "no pain" (score of 0) or "worst imaginable pain" (score of 10).
Secondary Outcome Measures
Intraoperative blood loss
amount of intraoperative blood loss
Operative time
in minutes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05147064
Brief Title
Minimal Invasive Surgery Versus Interlaminar Decompression in Lumbar Canal Stenosis
Official Title
Minimally Invasive Surgery Versus Conventional Open Interlaminar Decompression in Treatment of Degenerative Lumbar Canal Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Conventional open surgery has been shown to be an effective procedure for LCS decompression. Minimally invasive surgery (MIS) through tubular retractors is a recently introduced alternative procedure for decompression of LCS.
The current study aims at evaluating the efficacy of minimally invasive surgery as a decompressive procedure in comparison to conventional open surgery for the treatment of patients with LCS.
Detailed Description
Lumbar canal stenosis (LCS) is defined as narrowing of the spinal canal, the vertebral foramina, and/or the lateral recesses, causing compression on the nearby neurologic structures. Degenerative LCS is one of the most common reasons for old patients to undergo spinal surgery. Neurogenic claudication is the most common symptom for LCS patients. The patients complain of pain or discomfort that radiates to the buttock, thigh and lower limb after walking for a certain distance, therefore leading to functional disability and decreased walking capacity. Conservative management is the first line of treatment in the absence of progressive neurologic deficit or intractable pain, consisting of physical therapy, medications (analgesics, steroids) and pain management procedures. Surgical intervention is recommended if the symptoms are persistent or worsening.
Various techniques are currently used for direct decompression of LCS. Conventional open surgery involves laminectomy that has been shown to be an effective procedure for LCS decompression. However, wide laminectomies disturbs the stability of bony and ligamentous structures and may exacerbate preexisting spondylolisthesis. Minimally invasive surgery (MIS) through tubular retractors is a recently introduced alternative procedure for decompression of LCS. This technique avoids detachment of the paraspinal muscles and may promote preservation of stabilizing ligamentous and bony spinal structures.
The current study aims at evaluating the efficacy of minimally invasive surgery as a decompressive procedure in comparison to conventional open surgery for the treatment of patients with LCS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
minimally invasive surgery, interlaminar decompression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
randomly allocated
Arm Title
group B
Arm Type
Experimental
Arm Description
randomly allocated
Intervention Type
Procedure
Intervention Name(s)
minimally invasive surgery
Intervention Description
using (tubular dilators, surgical microscope, and/ or endoscope). the other group will be operated by conventional inter laminar decompression.
Intervention Type
Procedure
Intervention Name(s)
conventional open surgery
Intervention Description
open interlaminar lumbar decompression
Primary Outcome Measure Information:
Title
Functional outcome
Description
Change of Oswestry disability index (ODI) is being assessed to compare the pre and post operative values.
This outcome measure is designed to assess function in activities of daily living for those with acute or chronic back pain.
The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).
Time Frame
Change of ODI is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.
Title
back pain and lower limb pain
Description
Change of visual analogue scale (VAS) is being assessed to compare the pre and post operative values. VAS is a continuous scale comprised of a horizontal line, usually 10 centimeters in length. For pain intensity, "no pain" (score of 0) or "worst imaginable pain" (score of 10).
Time Frame
using visual analogue scale change of the values is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.
Secondary Outcome Measure Information:
Title
Intraoperative blood loss
Description
amount of intraoperative blood loss
Time Frame
intraoperative
Title
Operative time
Description
in minutes
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patient with lumbar canal stenosis From 18_70 years old
Exclusion Criteria:
instability Infection Tumours of vertebrae
12. IPD Sharing Statement
Learn more about this trial
Minimal Invasive Surgery Versus Interlaminar Decompression in Lumbar Canal Stenosis
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