Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis
NCT ID: NCT07281625
Last Updated: 2025-12-15
Study Results
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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RECRUITING
EARLY_PHASE1
60 participants
INTERVENTIONAL
2025-10-01
2025-12-31
Brief Summary
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This study will compare two types of surgery used to treat lumbar spinal stenosis: decompressive laminectomy alone and decompressive laminectomy with transpedicular screw fixation. Patients will be randomly assigned to one of the two surgical options.
The purpose of this study is to determine which approach provides better pain relief, improved function, fewer complications, and better spinal stability after surgery.
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Detailed Description
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This randomized controlled trial will be conducted at the Department of Neurosurgery, Services Hospital Lahore, over a six-month period. A total of 60 participants aged 30-60 years with MRI-confirmed multilevel lumbar spinal stenosis who have failed six weeks of conservative treatment will be enrolled using consecutive sampling and randomized into two equal study groups. Group A will undergo decompressive laminectomy alone, while Group B will undergo decompressive laminectomy with transpedicular screw fixation.
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Outcome measures will include operative time, postoperative complications, length of hospital stay, pain assessed using the Visual Analog Scale (VAS) at baseline, day 7, and 3 months, and functional status assessed using the Oswestry Disability Index (ODI) at baseline and 3 months. Postoperative radiographs will be used to evaluate spinal stability and bony fusion at 3 months.
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Data will be analyzed using SPSS version 25. Continuous variables will be presented as mean ± standard deviation and analyzed using an independent sample t-test. Categorical variables will be compared using the chi-square test, with a significance threshold of p ≤ 0.05. The study aims to evaluate whether decompression alone or decompression with transpedicular fixation results in superior clinical and radiological outcomes.
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Decompressive Laminectomy Only
Surgical decompressive laminectomy performed without instrumented fixation in patients with multilevel lumbar spinal stenosis.
Decompressive Laminectomy
Surgical removal of the vertebral lamina to decompress the spinal canal in patients with multilevel lumbar spinal stenosis. No instrumentation or fixation is applied.
Decompressive Laminectomy With Transpedicular Screw Fixation
Surgical decompression via laminectomy combined with spinal stabilization using transpedicular pedicle screws for multilevel lumbar spinal stenosis to prevent postoperative instability and provide bony fusion.
Laminectomy With Transpedicular Screw Fixation
Surgical decompressive laminectomy combined with transpedicular screw fixation to provide additional spinal stability in patients with multilevel lumbar spinal stenosis.
Decompressive Laminectomy
Surgical removal of the vertebral lamina to decompress the spinal canal in patients with multilevel lumbar spinal stenosis. No instrumentation or fixation is applied.
Decompressive Laminectomy With Transpedicular Screw Fixation
Surgical decompression via laminectomy combined with spinal stabilization using transpedicular pedicle screws for multilevel lumbar spinal stenosis to prevent postoperative instability and provide bony fusion.
Interventions
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Decompressive Laminectomy
Surgical removal of the vertebral lamina to decompress the spinal canal in patients with multilevel lumbar spinal stenosis. No instrumentation or fixation is applied.
Decompressive Laminectomy With Transpedicular Screw Fixation
Surgical decompression via laminectomy combined with spinal stabilization using transpedicular pedicle screws for multilevel lumbar spinal stenosis to prevent postoperative instability and provide bony fusion.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of lumbar spinal stenosis based on MRI criteria (anteroposterior canal diameter \<10-15 mm or cross-sectional area \<75-145 mm²)
* Multilevel disc herniation
* Degenerative disc disease with Pfirrmann grade 3-5 on T2-weighted MRI
* Failure of at least six weeks of conservative treatment
Exclusion Criteria
* Spinal malignancy
* Congenital lumbar spinal stenosis, scoliosis, or kyphoscoliosis
* Lumbar spondylolisthesis grade 3-5
* Significant comorbidities including diabetes mellitus or ischemic heart disease
30 Years
60 Years
ALL
No
Sponsors
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Punjab Health Care Commission
OTHER
Responsible Party
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Hira Umar
Doctor
Principal Investigators
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Hira Umar, MBBS
Role: PRINCIPAL_INVESTIGATOR
SIMS
Locations
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Services Institute of Medical Sciences
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHL-LSS-Trial
Identifier Type: -
Identifier Source: org_study_id
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