Clinical trial NCT05147064: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: minimally invasive surgery
interlaminar decompression
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* instability Infection Tumours of vertebrae

Primary outcomes:
measure: Functional outcome
timeFrame: Change of ODI is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.
measure: back pain and lower limb pain
timeFrame: using visual analogue scale change of the values is being assessed immediate pre operatively, after 3, 6,and 12 months post operatively.
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: intraoperative
measure: Operative time
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References: