Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis

December 2, 2025 updated by: Hira Umar, Punjab Health Care Commission

A Randomized Controlled Trial Comparing Surgical Outcomes of Decompressive Laminectomy Versus Decompressive Laminectomy With Transpedicular Screw Fixation in Multilevel Lumbar Spinal Stenosis

Lumbar spinal stenosis is a condition where the spinal canal becomes narrowed and can cause symptoms such as back pain, numbness, leg pain, and difficulty walking. Surgery is often considered when symptoms do not improve with medical treatment.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lumbar spinal stenosis (LSS) is a common degenerative spinal disorder causing neurogenic claudication, back pain, radiculopathy, and functional limitation. Multilevel stenosis is frequently associated with degenerative disc disease and facet joint hypertrophy. Decompressive laminectomy is a widely performed procedure; however, concerns exist regarding postoperative instability, which may affect long-term outcomes. Instrumented fixation using transpedicular screws may provide stability but also increases operative time, surgical risk, and healthcare cost.

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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Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 60000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Decompressive Laminectomy Only
Surgical decompressive laminectomy performed without instrumented fixation in patients with multilevel lumbar spinal stenosis.
Procedure: 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.
Procedure: 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.
Experimental: 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.
Procedure: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oswestry Disability Index (ODI)
Time Frame: Baseline and 3 months after surgery
Functional disability will be assessed using the Oswestry Disability Index (ODI), recorded preoperatively and at 3-month follow-up to measure improvement in functional outcome.
Baseline and 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Punjab Health Care Commission

Investigators

  • Principal Investigator: Hira Umar, MBBS, SIMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHL-LSS-Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Plans for sharing individual participant data have not yet been finalized. Data sharing may be limited by institutional policy, ethical requirements, and patient confidentiality considerations. If a data-sharing framework is approved in the future, the plan will be updated in this record.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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