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Набор по приглашению NCT05033457

Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis

— Наблюдательное Lumbar Disc Herniation

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: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy.
Кому может быть актуально
Состояния в реестре: Lumbar Disc Herniation. Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
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Официальное название

Comparative Study Between Unilateral Biportal Endoscopy Technique and Percutaneous Endoscopic Transforaminal Discectomy for the Treatment of Lumbar Spinal Canal Stenosis

Обзор

OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD. METHODS In the period from July 2020 to December 2020, using UBE or PETD to treat lumbar canal stenosis.Patients were classified into two groups based on the surgery they had undergone. Preoperative and postoperative MR image was used to evaluate the removal rate of lumbar disc herniated material by two surgical methods. The two surgical methods are also compared and evaluated in terms of operation time, incision size, hospitalization time, etc.

Подробное описание

It was performed as a retrospective analysis of prospectively collected data on patients received spinal endoscopic decompression between July 2020 to December 2020 was conducted. All patients underwent lumbar MRI examination with the result of L5-S1 disc herniation，accompanied by claudication or lower extremity radiation pain and other nerve compression symptoms. The symptoms have not improved with conservative treatments including physical therapy, medication, and epidural injection procedures for a minimum of 12 weeks. Patients who hadprevious spine surgery, infection, trauma, tumors or spondylolisthesis were excluded. The surgery was performed by the same experienced spinal surgeon and the surgical patient were closely followed for 3 months after surgery.

The investigators performed two kinds of endoscopic lumbar discectomy：unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD).

Вмешательства

  • Процедура unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy
    Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group.Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group.

Первичные конечные точки

  • Cross-sectional area of the preoperative lumbar intervertebral disc [Срок оценки: preoperative]
  • Cross-sectional area of the preoperative spinal canal [Срок оценки: preoperative]
  • Cross-sectional area of the postoperative lumbar intervertebral disc [Срок оценки: 3 months after surgery]
  • preoperative ODI [Срок оценки: preoperative]
  • ODI on 3 months after operation [Срок оценки: 3 months after surgery]
  • ODI at the final follow-up [Срок оценки: Final follow-up]
  • preoperative VAS back pain score [Срок оценки: preoperative]
  • preoperative VAS leg pain score [Срок оценки: preoperative]
  • VAS back pain score on postoperative day 1 [Срок оценки: 1 day after operation]
  • VAS leg pain score on postoperative day 1 [Срок оценки: 1 day after operation]
Вторичные конечные точки (2)
  • operation time [Срок оценки: intraoperative]
  • incision size [Срок оценки: intraoperative]

Критерии участия

Критерии включения

\- Single-segment lumbar disc herniation/lumbar spinal stenosis

Критерии исключения

  • Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes

Критерии включения

Критерии включения

Single-segment lumbar disc herniation Symptoms of nerve compression

Критерии исключения

foraminal and extraforaminal disc herniation multilevel disc herniation, spinal stenosis spondylolisthesis scoliosis prior lumbar surgery spinal infection spinal tumor a history of hip or knee arthritis

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • Shanxi Medical University — Taiyuan

Идентификаторы

NCT: NCT05033457 · sxsrmyyjzwc202101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗