Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
To explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy.
详细描述
The study was to explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy. 128 patients with single-segmental LDH were randomly divided into discectomy with Dynesys group(group A) and simple discectomy group(group B). Both groups were evaluated by Visual Analogue Score(VAS), Oswestry Disability Index(ODI), radiological evidence of intervertebral height and range of motion(ROM) of the treated segment at pre- and post-operation. Operation duration and blood loss was recorded. The clinical outcomes and complications were evaluated afterwards. All patients received a 2-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria was Single-segmental LDH with low back pain and radicular pain.
排除标准
- •Exclusion criterias were lumbar stenosis(LSS), lumbar spondylolysis and degenerative spondylolisthesis, spinal deformity, lumbar surgery history, obviously osteoporosis, vertebral fracture, cauda equina syndrome, ankylosing spondylitis, tuberculosis, infection, tumor, obesity.
结局指标
主要结局
Oswestry Disability Index
时间窗: 2 year
Oswestry Disability Index is for movement function, Questionnaire examines perceived level of disability in everyday activities of daily living. The ODI score (index) is calculated as: For example: If all 10 sections are completed, the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%; If one section is missed (or not applicable), the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%.
Range of motion(ROM)
时间窗: 2 year
ROM was measured by the flexion-extension radiographs of both endplates of the treated segment.
visual analog scale
时间窗: 2 year
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Intervertebral height
时间窗: 2 year
Intervertebral height in X-ray is for recontruction of the intervertebral space.
次要结局
未报告次要终点