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Набор по приглашению NCT06685575

Comparative Outcomes of Conventional TLIF With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery

Без фазы С лечением Foraminal 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: Endoscopic Foraminotomy Surgery.
Кому может быть актуально
Состояния в реестре: Foraminal Stenosis. Базовые параметры: 30 лет — 80 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
Таиланд
Следующий шаг
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Официальное название

Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study

Обзор

Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study

Подробное описание

Backgrounds :

Lumbar foraminal stenosis is a condition in which a spinal nerve is entrapped in a narrow lumbar foramen in degenerative lumbar spinal disorders. The gold standard treatment of this condition has not been proposed yet. Several different techniques for this problem has been described, including foraminotomy, facetectomy, partial pediculectomy, fusion, and distraction instrumentation.Nowadays, due to the great advancement of the technology in endoscopy expanded the indication of endoscopic decompression from the central canal to the extraforaminal zone, Which was difficult to gain access from the mere microscope.

Objectives :

To compare outcomes between posterior decompression With conventional transforaminal lumbar interbody fusion (TLIF) and full-endoscopic foraminoplasty (FELF) in stable lumbar foraminal Stenosis

Methods :

This is an ambi-directional cohort study, In retrospective part conducted from JAN2019-JAN2024 in Queen Savang Vadhana Memorial Hospital and the prospective part conducted from AUG2024 - JUNE 2025, Thailand. 60 patients presented with stable lumbar foraminal stenosis were divided into posterior decompression with conventional transforaminal lumbar interbody fusion (TLIF) group ( N=30) and full-endoscopic lumbar foraminoplasty (FELF) group (N=30). Demographic data and pre-perioperative parameters were analyzed. For TLIF group , Standard procedure had been performed.

Posterior decompression, pedicle screws and interbody cage ( Mont blanc, Spineway, France) insertion under image intensifier ( BV Pulsera,Philips).For endoscopic foraminoplasty , uniportal stenoscope ( Vertebris ,Riwospine ) was used to perform endoscopic decompressive surgery. Post-operative outcome , for instance , Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) were recorded at preoperative, post-op day1, 3 month, 6 month and 1 year respectively. Other parameters such as estimated blood loss (EBL), length of hospital stay and post- operative complications were also recorded

Вмешательства

  • Процедура Endoscopic Foraminotomy Surgery
    Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis

Первичные конечные точки

  • Oswestry disability index (ODI) score post-operation at 12months [Срок оценки: 12 months]
Вторичные конечные точки (7)
  • Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months [Срок оценки: 6week, 3 months and 6 months]
  • visual analog scale (VAS) of pain both leg and back [Срок оценки: 1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months]
  • estimated blood loss (EBL) [Срок оценки: perioperation]
  • operative time [Срок оценки: perioperation]
  • length of hospital stay [Срок оценки: from 3 days to 1 week]
  • time return to work [Срок оценки: through the study completion, an average of 1 year]
  • postoperative complications [Срок оценки: through the study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Age 30-80
  • Persist radiculopathy and sciatica pain
  • Patient that was diagnosed Stable lumbar foraminal stenosis
  • Failed conservative for at least 6 months
  • Patients who willing to join the study

Критерии исключения

  • Patients with unstable lumbar foraminal stenosis
  • Patient with spine infection or tumor or fracture
  • Patient with BMD less than -2.5 or osteopenia
  • Patient with inflammatory joint diseases who on steroids
  • Patient who has undergo with surgery that inserted metals in back
  • Unable to answer questionnaires
  • Cannot tolerate surgery due to severe medical comorbidities

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Таиланд · 1 центр
  • Tanyasinee Soonthornthum — Chon Buri

Идентификаторы

NCT: NCT06685575 · 020/2567

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗