Lumbar Spinal Stenosis Clinical Trial
Official title:
Clinical Study of Microendoscopic Decompressive Laminotomy for Treatment of Lumbar Spinal Stenosis
The study is a prospective outcome study to evaluate the effectiveness and treatment
outcomes of microendoscopic decompressive laminotomy (MEDL) with objective evaluation tools.
The patients who fulfill the selection criteria will be enrolled to collect the
pre-operative clinical data including demographic data, image studies, and functional
evaluation for neurological symptoms and disability.
The patient will receive MEDL and post-operative follow-up will be arranged at 1 week, 1
month, 6 months, and 12 months after the operation. All the collected data will be analyzed
to evaluate the efficacy and treatment results of MEDL.
The patients undergoing microendoscopic decompressive laminotomy (MEDL) for lumbar spinal
stenosis (LSS) between will be enrolled in this prospective study. The patients included
must fulfill the following selection criteria:
- neurogenic claudication or radicular leg pain with associated neurologic signs
referring to the LSS syndrome;
- moderate to severe spinal canal stenosis shown on cross-sectional imaging such as MRI
or CT scan;
- failure of conservative treatment for at least three months.
The patients who presents with either mechanical low back pain or segmental instability.
Mechanical lower back pain is defined as pain that was induced by posture change, or that
prevents the patient from sitting or standing for more than 30 minutes. Patients are
considered to have segmental instability if they had isthmic spondylolisthesis, degenerative
spondylolisthesis with more than 4 mm of translation or intervertebral angle reversal on
dynamic radiographs.18 Surgical techniques
All the surgical procedures will be performed by a single surgeon (J. P.). The patients is
positioned prone on the Relton-Hall frame after general anesthesia. Decompression is done
under the endoscope with the tubular retraction system METRx (Medtronics, Minneapolis, MN).
For patients with unilateral neurological symptoms, we will perform unilateral laminotomy
and foraminotomy. For patients with bilateral neurological symptoms, we will performe
unilateral laminotomy for bilateral decompression (ULBD) to decompress the central canal and
bilateral lateral recesses.
When performing multiple-level decompression, the skin incision will be centered at the
midpoint between selected intervertebral disc levels. The incision can be mobilized one
level above or below after releasing the underlying connective tissues. Then we can set up
the tubular retractor system through separate muscular portals for each level. For patients
with small stature, we can perform a three-level surgery through a single surgical wound,
just as the same size as we perform the single-level surgery.
All the patients will have routine AP, lateral, dynamic lateral radiographs pre-operatively,
six months after the surgery, and at final follow-up. Post-operative instability is defined
as progression of listhesis or scoliosis on dynamic radiographs.
Every patient will MR images of the lumbar spine before the surgery. The severity of
stenosis is classified according to the cross sectional area of the dura sac at the axial
plane on T1-weighted MR images—severe stenosis for less than 76 mm2, moderate stenosis for
between 76 and 100 mm2, and mild stenosis for more than 100 mm2. When MRI is
contraindicated, CT-myelography will be used instead.
Outcomes assessment will done with Oswestry Disability Index (ODI) for the overall
disability and the Japanese Orthopedic Association (JOA) score for the clinical symptoms and
signs. The patients will receive evaluation before the surgery, at six months, and at the
final follow-up examination. The range of ODI is 100 ~ 0 with a lower index corresponding to
a better result. Significant improvement is defined as more than 15 points of improvement
after the treatment. The range of JOA score is -3 ~ 29 with a higher score corresponding to
a better result. The improvement rate based on JOA score is calculated as follows:
(pre-operative score - post-operative score)/(29 - pre-operative score) × 100%. The clinical
results are classified into four grades by the improvement rate: excellent (more than 75%),
good (between 51% and 75%), fair (between 26% and 50%), and poor (less than 26%). The
success of treatment is defined as more than 25% improvement rate in JOA score.20 At the
final follow-up, we will inquire each patient if he or she is satisfied with the treatment
results.
The data about the pre-operative comorbidities, intra-operative, peri-operative, and
post-operative complications will be retrieved from medical chart review.
Distribution of gender, age, clinical characteristics (coexistence of spondylolisthesis or
scoliosis, severity of stenosis, and levels of decompression), and self-assessed
satisfaction by the binary outcome of treatment (success or not, based on the JOA score;
significant improvement of not, base on the ODI) will be tabulated. Fisher exact test will
be preformed to compare the difference between the two groups. Odds ratios will be
calculated by using the univariate logistic regression. Variables with two-sided p-value
less than 0.05 were considered as significant factors associated with successful treatment.
All statistical analyses are performed with statistical software, SAS version 9.1 (SAS
Institute Inc, Cary, NC).
;
Observational Model: Case-Only, Time Perspective: Prospective
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