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Clinical Trials/NCT05147064
NCT05147064
Unknown
Not Applicable

Minimally Invasive Surgery Versus Conventional Open Interlaminar Decompression in Treatment of Degenerative Lumbar Canal Stenosis

Assiut University0 sites40 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spinal Stenosis
Sponsor
Assiut University
Enrollment
40
Primary Endpoint
back pain and lower limb pain
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
December 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Garamoun Abd El Zaher

Assistant lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

  • all patient with lumbar canal stenosis From 18_70 years old

Exclusion Criteria

  • instability Infection Tumours of vertebrae

Outcomes

Primary Outcomes

back pain and lower limb pain

Time Frame: using visual analogue scale change of the values is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.

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).

Functional outcome

Time Frame: Change of ODI is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.

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).

Secondary Outcomes

  • Intraoperative blood loss(intraoperative)
  • Operative time(intraoperative)

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