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Minimal Invasive Surgery Versus Interlaminar Decompression in Lumbar Canal Stenosis

NCT ID: NCT05147064

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Lumbar Spinal Stenosis

Keywords

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minimally invasive surgery interlaminar decompression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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group A

randomly allocated

Group Type EXPERIMENTAL

minimally invasive surgery

Intervention Type PROCEDURE

using (tubular dilators, surgical microscope, and/ or endoscope). the other group will be operated by conventional inter laminar decompression.

group B

randomly allocated

Group Type EXPERIMENTAL

conventional open surgery

Intervention Type PROCEDURE

open interlaminar lumbar decompression

Interventions

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minimally invasive surgery

using (tubular dilators, surgical microscope, and/ or endoscope). the other group will be operated by conventional inter laminar decompression.

Intervention Type PROCEDURE

conventional open surgery

open interlaminar lumbar decompression

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all patient with lumbar canal stenosis From 18\_70 years old

Exclusion Criteria

* instability Infection Tumours of vertebrae
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Garamoun Abd El Zaher

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Minimal invasive surgery LCS

Identifier Type: -

Identifier Source: org_study_id