Decompressive laminectomy alone versus laminectomy with transpedicular screw fixation for lumbar spinal stenosis
A Randomized Controlled Trial Comparing Surgical Outcomes of Decompressive Laminectomy Versus Decompressive Laminectomy With Transpedicular Screw Fixation in Multilevel Lumbar Spinal Stenosis
Adults age 30–60 with multilevel lumbar spinal stenosis who haven't improved after six weeks of non-surgical care will be randomly assigned to decompressive laminectomy alone or to laminectomy plus transpedicular screw fixation to see which option relieves pain, improves function, and gives better spinal stability.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | Punjab Health Care Commission Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07281625 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 60 adults aged 30–60 with MRI-confirmed multilevel lumbar spinal stenosis who failed at least six weeks of conservative treatment. Participants will be randomized to decompressive laminectomy alone or decompressive laminectomy with transpedicular screw fixation and followed for postoperative outcomes. Primary measures include operative time, postoperative complications, length of stay, pain by VAS at baseline, day 7 and 3 months, and function by ODI at baseline and 3 months, with radiographs used to assess spinal stability and fusion at 3 months. The single-center trial will be conducted at the Department of Neurosurgery, Services Institute of Medical Sciences in Lahore over a six-month recruitment period.
Who should consider this trial
Good fit: Ideal candidates are adults 30–60 with MRI-confirmed multilevel lumbar spinal stenosis, Pfirrmann grade 3–5 degenerative disc disease, who have failed at least six weeks of conservative treatment and have no prior lumbar surgery or major comorbidities.
Not a fit: Patients with prior lumbar spine surgery, spinal malignancy, congenital deformity or scoliosis/kyphoscoliosis, high-grade spondylolisthesis (grade 3–5), or significant comorbidities such as diabetes or ischemic heart disease are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the trial could identify which surgical approach provides better short-term pain relief, function, and spinal stability and help surgeons reduce complications and future procedures.
How similar studies have performed: Previous randomized and observational studies have reported mixed results, with some selected-patient series suggesting fusion can improve stability or reduce reoperation but other studies showing little clear long-term functional advantage and higher complication rates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 30-60 years * 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: * Previous history of lumbar spine surgery * Spinal malignancy * Congenital lumbar spinal stenosis, scoliosis, or kyphoscoliosis * Lumbar spondylolisthesis grade 3-5 * Significant comorbidities including diabetes mellitus or ischemic heart disease
Where this trial is running
Lahore, Punjab Province
- Services Institute of Medical Sciences — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Hira Umar, MBBS — Sims Siut
- Study coordinator: Hira Umar, MBBS
- Email: quickcareclinicdr03@gmail.com
- Phone: +92 317 4226862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.