Comparison of Endoscopic Lumbar Decompression and Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Degenerative Lumbar Spondylolisthesis
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: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression.
- Кому может быть актуально
- Состояния в реестре: Degenerative Lumbar Spondylolisthesis, Lumbar Degenerative Disease, Lumbar Spinal Stenosis. Базовые параметры: от 40 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of Endoscopic Lumbar Decompression and Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion (MIS-TLIF) for Degenerative Lumbar Spondylolisthesis: A Randomized Controlled Study
Обзор
Comparing the functional and radiographic outcomes in surgical treatment in failed conservative treatment, single-level low grade degenerative lumbar spondylolisthesis between Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion, which is conventional treatment recently, and Endoscopic Lumbar Decompression, which is minimal invasive in symptomatic treatment.
Подробное описание
This was a randomized controlled trial in patient with single-level low grade degenerative lumbar spondylolisthesis with failed conservatives treatment, by comparing two group of surgical intervention between Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) and Endoscopic lumbar decompression using functional outcomes.
The participants were randomized into two groups with 33 cases each group (Total = 66) by using computer generated program with block of four randomization with allocation ratio 1:1. The control group received conventional treatment which is Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion while the experimental group received endoscopic lumbar decompression. Using ODI score as primary outcome. Data were analyzed using chi-square test for categorical data (eg, sex, symptoms of weakness and numbness, level of spondylolisthesis) and unpaired T-test for continuous data (eg. VAS score, ODI, slippage percentage, lumbar lordosis degree, slip angle, op time) which considered significant difference of the outcomes when p \< 0.05 with a power of 80%. Consider endoscopic decompression is non-inferiority to MIS-TLIF when upper limit of the one-sided 95%CI for the differences in ODI means is less than margin (12.8 points) If the results show that endoscopic decompression is non-inferiority to MIS TLIF, endoscopic lumbar decompression may be a choice of treatments giving benefit of minimal invasive surgery and avoid interbody fusion complication such as pseudoarthrosis, adjacent problems and operative blood loss
Вмешательства
- Процедура Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression
The LE-ULBD: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression is a single portal through lamina with instrument to decompression both side of the spinal canal, giving strength of preserve facet joint, preserve spinal musculature, mitigate the risk of adjacent fusion and lesser bleeding
Первичные конечные точки
- Oswestry Disability Index score [Срок оценки: 1 year; Preoperative and post-operative at 12 months]
Вторичные конечные точки (9)
- Visual analog scale of leg pain [Срок оценки: 1 year; Preoperative and post-operative at 1,3,6 and 12 months]
- Visual analog scale of back pain [Срок оценки: 1 year; Preoperative and post-operative at 1,3,6 and 12 months]
- Modified Macnab criteria [Срок оценки: 1 year; Preoperative and post-operative at 1,3,6 and 12 months]
- Operative time [Срок оценки: 1 day; From patient's skin is cut, through each intervention surgery completion (minute) when the skin is closed]
- Length of hospital stay [Срок оценки: 1 year; The date from the patients had been admitted to discharge]
- Amount of blood loss [Срок оценки: 1 day; Start from the skin's is cut through surgery period and postoperative until the drain bottle was removed.]
- Radiographic outcomes: lumbar slip percentage [Срок оценки: 1 year; Preoperative and post-operative at 0,6 and 12 months]
- Radiographic outcomes: Slip angle [Срок оценки: 1 year; Preoperative and post-operative at 0,6,12 months]
- Radiographic outcomes: lumbar lordosis degree [Срок оценки: 1 year; Preoperative and post-operative at 0,6,12 months]
Критерии участия
Критерии включения
- Single level lumbar degenerative spondylolisthesis (Meyerding Grading Grade I or II).
- Failed conservative treatment for at least 3 months.
- No instability evidence of levels of lesion (Consideration from translation more than 5 mm or angulation change more than 10 degree in flexion and extension L-S plain films ).
- Able to follow up for at least 12 months.
- Patient who vorantarily agree to participate in research.
Критерии исключения
- Patients with severe foraminal stenosis diagnosed by MRI.
- Patients who have previously undergone lumbar spine surgery (revision surgery).
- Patients with other abnormalities in the lumbar spine, such as infection, tumors, or fractures.
- Patients who cannot undergo surgery due to underlying conditions or who cannot maintain the prone position for extended periods.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Таиланд · 1 центр
- Queen Savang Nadhana Memorial Hospital — Chon Buri
Идентификаторы
NCT: NCT06749314 · 024/2567