Actively Recruiting
A Randomized Controlled Trial Comparing Surgical Outcomes of Decompressive Laminectomy Versus Decompressive Laminectomy With Transpedicular Screw Fixation in Multilevel Lumbar Spinal Stenosis
Led by Punjab Health Care Commission · Updated on 2025-12-15
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Lumbar spinal stenosis is a condition where the spinal canal narrows, causing back pain, numbness, leg pain, and difficulty walking. This research aims to compare two surgical approaches for treating lumbar spinal stenosis: decompressive laminectomy alone and decompressive laminectomy combined with transpedicular screw fixation. The study seeks to find which surgery offers better pain relief, improved function, fewer complications, and greater spinal stability after surgery. Participants aged 30 to 60 years with MRI-confirmed multilevel lumbar spinal stenosis who have not improved after six weeks of conservative treatment will be randomly assigned to one of two groups. One group will have decompressive laminectomy alone, which involves removing the vertebral lamina to relieve pressure on the spinal canal. The other group will have decompressive laminectomy with additional spinal stabilization using transpedicular screw fixation to prevent instability and promote fusion. During the study, researchers will measure pain levels using the Visual Analog Scale (VAS) at the start, day 7, and three months after surgery, and functional status using the Oswestry Disability Index (ODI) at the start and three months post-surgery. Postoperative X-rays will assess spinal stability and bone fusion. Other data collected include operative time, complications, and hospital stay length. The total study will last six months, with participants closely monitored throughout.
CONDITIONS
Brief Title
Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 60 years
- Diagnosis of lumbar spinal stenosis confirmed by MRI
- Multilevel disc herniation present
- Degenerative disc disease with Pfirrmann grade 3 to 5 on T2-weighted MRI
- Symptoms not improving after at least six weeks of conservative treatment
You will not qualify if you...
- Previous lumbar spine surgery
- Presence of spinal malignancy
- Congenital lumbar spinal stenosis, scoliosis, or kyphoscoliosis
- Lumbar spondylolisthesis grade 3 to 5
- Significant health conditions such as diabetes mellitus or ischemic heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and hospital stay
Participants undergo either decompressive laminectomy alone or decompressive laminectomy combined with transpedicular screw fixation to treat lumbar spinal stenosis.
1 surgery visit and hospital stay
Duration - 3 months
Participants are followed to assess pain, functional status, complications, and spinal stability after surgery.
3 visits (Day 7, 1 month, and 3 months post-surgery)
Trial Site Locations
Total: 1 location
1
Services Institute of Medical Sciences
Lahore, Punjab Province, Pakistan, 60000
Actively Recruiting
Research Team
H
Hira Umar, MBBS
F
Fazal Rehman, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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