NCT06394089招募中不适用
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
A single-center, prospective cohort trial aims to provide stronger evidence regarding the impact of degenerative spondylolisthesis on the clinical outcome of unilateral biportal endoscopy for lumbar spinal stenosis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 50-80 years
- •Diagnosis of LSS affecting 1-2 vertebral levels
- •Predominant manifestation of neurogenic intermittent claudication, with ineffective conservative treatment for at least 3 months
- •Presence of lumbar DS of less than grade II and absence of spine instability
- •Willingness to participate in the study and complete follow-up assessments.
排除标准
- •Diagnosis of isthmic lumbar spondylolisthesis or lumbar DS of grade ≥II
- •Evidence of instability at the affected vertebral level (intervertebral angle change > 15° and/or vertebral translation ≥ 4.5 mm in standing flexion-extension radiographs of the lumbar spine)
- •History of prior surgery at the affected vertebral level
- •Presence of scoliosis with a Cobb angle >20º
- •Presence of other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
- •Medical disorders that preclude surgical tolerance
- •Participation in other clinical research projects related to the treatment of lumbar spinal stenosis.
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: From enrollment to the end of follow-up at 2 year
0-100%, the higher the score, the more severe the lumbar spine dysfunction
次要结局
- White blood cell count(From enrollment to 3 days after surgery)
- Creatine kinase level(From enrollment to 3 days after surgery)
- Lactate dehydrogenase level(From enrollment to 3 days after surgery)
- Myoglobin level(From enrollment to 3 days after surgery)
- X-ray(From enrollment to the end of follow-up at 2 year)
- Computed tomography (CT) scan(From enrollment to the end of follow-up at 2 year)
- Magnetic resonance imaging (MRI)(From enrollment to the end of follow-up at 2 year)
- Surgical complication(From enrollment to the end of follow-up at 2 year)
- Visual analog scale (VAS) score for lower back pain(From enrollment to the end of follow-up at 2 year)
- Visual analog scale (VAS) score for leg pain(From enrollment to the end of follow-up at 2 year)
- Operative time(Immediately after the surgery)
- Intraoperative blood loss(Immediately after the surgery)
- Postoperative hospital stays(Immediately after the discharge)
- Japanese Orthopaedic Association (JOA) score(From enrollment to the end of follow-up at 2 year)
- Modified MacNab criteria(From enrollment to the end of follow-up at 2 year)
- Improvement ratio of Visual analog scale (VAS) score for lower back pain(From enrollment to the end of follow-up at 2 year)
- Improvement ratio of Visual analog scale (VAS) score for leg pain(From enrollment to the end of follow-up at 2 year)
- Improvement ratio of Japanese Orthopaedic Association (JOA) score(From enrollment to the end of follow-up at 2 year)
- Improvement ratio of Oswestry Disability Index (ODI)(From enrollment to the end of follow-up at 2 year)
- Percentage of neutrophils (N%)(From enrollment to 3 days after surgery)
- C-reactive protein level(From enrollment to 3 days after surgery)
研究者
研究点 (1)
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