Идёт набор NCT07281625

Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis

Ранняя фаза I С лечением Lumbar Spinal Stenosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Decompressive Laminectomy, Decompressive Laminectomy With Transpedicular Screw Fixation.
Кому может быть актуально: Состояния в реестре: Lumbar Spinal Stenosis. Базовые параметры: 30 лет — 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Пакистан
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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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Вмешательства

Процедура 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.
Процедура 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.

Первичные конечные точки

Change in Oswestry Disability Index (ODI) [Срок оценки: Baseline and 3 months after surgery]

Критерии участия

Критерии включения

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