A Study on the Clinical Use of a New Expandable OLIF Cage With Posterior Bone Grafting in Lumbar Spine Surgery
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: Expandable OLIF cage with posterior bone grafting, Conventional OLIF cage.
- Кому может быть актуально
- Состояния в реестре: Lumbar Spondylolisthesis, Degenerative Lumbar Scoliosis, Lumbar Disc Herniation, Lumbar Spinal Stenosis. Базовые параметры: 40 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Multi-Center Randomized Controlled Clinical Study on the Application of a Novel Expandable Posterior Bone Grafting OLIF Cage
Обзор
This clinical trial aims to evaluate the safety and effectiveness of a novel expandable OLIF (Oblique Lateral Interbody Fusion) cage with posterior bone grafting in patients with lumbar degenerative diseases. OLIF is a minimally invasive spinal surgery technique that restores intervertebral height and relieves nerve compression by placing a cage into the disc space. The new device allows surgeons to adjust the height of the cage during surgery and deliver bone grafts through a special channel after expansion. This study compares the outcomes of patients receiving the new cage versus those treated with a conventional OLIF cage. The trial will assess pain relief, functional improvement, spinal stability, fusion success, and potential complications. Radiological images and patient-reported scores (like VAS and ODI) will be collected over 12 months. The study includes patients aged 40 to 80 with single-level lumbar spine disease who have not improved after at least 6 months of conservative treatment. This study will help determine whether the new expandable cage offers clinical advantages and better long-term outcomes for patients undergoing OLIF surgery.
Вмешательства
- Устройство Expandable OLIF cage with posterior bone grafting
This intervention involves the use of a novel expandable OLIF cage that allows intraoperative height adjustment and posterior bone grafting through a dedicated channel. The device is designed to restore intervertebral height and lumbar lordosis while minimizing endplate injury. Bone grafts (autologous or synthetic) are delivered after expansion to enhance fusion. This design aims to reduce cage subsidence, improve fusion rates, and simplify the surgical workflow compared to conventional OLIF cag - Устройство Conventional OLIF cage
Participants in the control group will undergo oblique lateral interbody fusion (OLIF) using a standard non-expandable interbody fusion cage. The cage has a fixed height and is inserted via the retroperitoneal approach. Bone grafts are packed into the cage prior to insertion through the anterior or lateral window. This represents the current standard practice for OLIF procedures and does not allow intraoperative height adjustment or posterior graft delivery. The procedure follows conventional OL
Первичные конечные точки
- Postoperative cage subsidence [Срок оценки: From enrollment to the 12th month after operation]
- ntraoperative cartilage endplate injury [Срок оценки: From enrollment to the 12th month after operation]
Вторичные конечные точки (5)
- Intervertebral Height [Срок оценки: From enrollment to the 12th month after operation]
- Clinical efficacy index of patients: VAS [Срок оценки: From enrollment to the 12th month after operation]
- Cobb angle of lumbar coronal plane [Срок оценки: From enrollment to the 12th month after operation]
- Cobb angle of lumbar deformity surface [Срок оценки: From enrollment to the 12th month after operation]
- Clinical efficacy index of patients: ODI [Срок оценки: From enrollment to the 12th month after operation]
Критерии участия
Inclusion Criteria:1: Age between 40 and 80 years (inclusive)
2: Clinically diagnosed with lumbar spondylolisthesis or lumbar spinal stenosis
3: Confirmed single-level lumbar degenerative disease
4: Affected level located at L2/3, L3/4, or L4/5
5: Failure of conservative treatment for at least 6 months
Exclusion Criteria:1: Patients requiring direct decompression of the spinal canal
2: History of prior lumbar or retroperitoneal surgery
3: Abnormal anatomy between the iliac vascular sheath and the psoas major muscle
4: Presence of active infection or other significant systemic diseases
5: Inability to complete surgical treatment or comply with follow-up due to various limitations
\-
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
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07028099 · QYFYEC2025-62