Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis

Punjab Health Care Commission

Status and phase: Enrolling; Early Phase 1

Conditions: Lumbar Spinal Stenosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07281625

SHL-LSS-Trial

Details and patient eligibility

About

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.

Full 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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Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Decompressive Laminectomy Only

Active Comparator group

Description:

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

Treatment:

Procedure: Decompressive Laminectomy With Transpedicular Screw Fixation

Procedure: Decompressive Laminectomy

Laminectomy With Transpedicular Screw Fixation

Experimental group

Description:

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

Treatment:

Procedure: Decompressive Laminectomy With Transpedicular Screw Fixation

Procedure: Decompressive Laminectomy