Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis

NCT07281625 | Recruiting Early Phase 1

• 1 other identifier: SHL-LSS-Trial
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Spinal Stenosis

Keywords

laminectomy; spinal stenosis; lumbar fusion; VAS pain score

Outcome Measures

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.

  Baseline and 3 months after surgery

Study Arms (2)

Decompressive Laminectomy Only

ACTIVE COMPARATOR

Surgical decompressive laminectomy performed without instrumented fixation in patients with multilevel lumbar spinal stenosis.

Procedure: Decompressive Laminectomy; Procedure: Decompressive Laminectomy With Transpedicular Screw Fixation

Laminectomy With Transpedicular Screw Fixation

EXPERIMENTAL

Surgical decompressive laminectomy combined with transpedicular screw fixation to provide additional spinal stability in patients with multilevel lumbar spinal stenosis.

Procedure: Decompressive Laminectomy; Procedure: Decompressive Laminectomy With Transpedicular Screw Fixation

Interventions

Decompressive Laminectomy With Transpedicular Screw Fixation PROCEDURE

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.

Decompressive Laminectomy Only; Laminectomy With Transpedicular Screw Fixation

Decompressive Laminectomy PROCEDURE

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 Only; Laminectomy With Transpedicular Screw Fixation

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Punjab Health Care Commission: lead

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 60000, Pakistan

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Hira Umar, MBBS

  SIMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hira Umar, MBBS

CONTACT

+92 317 4226862; quickcareclinicdr03@gmail.com

Fazal Rehman, MBBS

CONTACT

03227793559; fazal171@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-10

Locations

PA (1)