Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age30-60
SponsorPunjab Health Care Commission

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous history of lumbar spine surgery

Spinal malignancy

Congenital lumbar spinal stenosis, scoliosis, or kyphoscoliosis

Lumbar spondylolisthesis grade 3-5

Trial design

Design model

Parallel

Treatments tested in this trial

  • Decompressive Laminectomy

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Decompressive Laminectomy OnlyActive comparator 2 interventions
Group B: Laminectomy With Transpedicular Screw FixationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Oswestry Disability Index (ODI)

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.

Time frame
Baseline and 3 months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Punjab Health Care Commission

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Sponsor institution