Research Protocol

Title of the research:

Minimally invasive surgery versus conventional open interlaminar decompression in treatment

of degenerative lumbar canal stenosis.

Background:

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.(1) 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 (2, 3), therefore leading to functional disability and decreased walking
capacity. (4, 5) 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.(6) Surgical intervention is
recommended if the symptoms are persistent or worsening. (7-9)

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.(10,11,12) However, this leads to disruption of many attachment points for
spinal back muscles: multifidus , interspinales, latissimus dorsi, thoracolumbar fascia and
serratus posterior inferior ,also wide laminectomies disturbs the stability of bony and
ligamentous structures and may exacerbate preexisting spondylolisthesis.(13,14) Minimally
invasive surgery (MIS) laminectomy through tubular or retractors is a recently introduced
alternative procedure for decompression of LCS.(18) This technique avoids detachment of the
paraspinal muscles and may promote preservation of stabilizing ligamentous and bony spinal
structures.(15,16,17) .

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.

Aim of the Research:

Aim of this study is to compare the clinical and radiological outcome of minimally invasive
surgery versus open interlaminar decompression in cases of degenerative LCS.

Research Methods and techniques:

1- Type of the study: A randomised controlled trial, patients will be randomly divided in to two
groups. All cases will be prospectively followed and assessed clinically and radiologically at 3,6,
and 12 months postoperatively. Randomization will be achieved with software (random-
allocation software.software.informer.com/2.0) and computer assisted.

2- Study subjects:
a. Inclusion criteria:
- Patients with degenerative LCS, diagnosed by outpatient clinic.
- Patients (age >18 and <70 years old).

b. Exclusion criteria:
- Deformity. - Infection of vertebrae.
-Tumor of vertebrae. - Instability.

c. Sample Size:
40 patients over 2 years.
20 patients will be treated by minimally invasive surgery using tubular dilators, surgical
microscope, and/ or endoscope.
20 patient will be treated by conventional open interlaminar decompression.

Research outcome measures:

a. Primary (main):
-post operative functional improvement (Oswestry disability index (ODI)) , post operative
pain will be measured by (Visual analogue scale (VAS))
b. secondary (subsidiary):
-post operative radiological assessment by MRI on lumbosacral spine, hospital stay, post-
operative complication and blood loss.

References:

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Clinical and radiologic features. Spine (Phila Pa 1976). 1995;20(10):1178-86.

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evaluation, management, and outcome measurements. Archives of physical medicine and rehabilitation.
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