A Randomized Controlled Trial Comparing Surgical Outcomes of Decompressive Laminectomy Versus Decompressive Laminectomy With Transpedicular Screw Fixation in Multilevel Lumbar Spinal Stenosis
概览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- Punjab Health Care Commission
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Oswestry Disability Index (ODI)
概览
简要总结
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.
详细描述
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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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Oswestry Disability Index (ODI)
时间窗: 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.
次要结局
未报告次要终点
研究者
Hira Umar
Doctor
Services Institute of Medical Sciences, Pakistan