NCT06365229已完成不适用
Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective, Non-randomized Cohort Trial Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS).
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
- •Diagnosed with LSS of 1-2 response levels
- •The predominant manifestation is neurogenic intermittent claudication, and conservative treatment has been ineffective for at least 3 months
- •Degenerative lumbar spondylolisthesis of less than I degree or without spine instability
- •Patients agree to participate in the study and are willing to complete the follow-up
排除标准
- •Isthmic lumbar spondylolisthesis or degenerative lumbar spondylolisthesis of greater than I degree
- •Instability at the response level
- •Prior surgical history at the response level
- •Scoliosis with Cobb angle >20 degrees
- •Other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
- •Patients with medical disorders who are unable to tolerate surgery
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: From enrollment to the end of follow-up at 1 year
0-100%, the higher the score, the more severe the lumbar spine dysfunction
次要结局
- Operation time(Immediately after the surgery)
- Erythrocyte sedimentation rate (ESR)(From enrollment to the follow-up at 2 weeks)
- VAS (visual analogue scale) for leg pain(From enrollment to the end of follow-up at 1 year)
- Stenosis grade(Baseline, pre-surgery)
- Surgical complication(From enrollment to the end of follow-up at 1 year)
- Blood loss(Immediately after the surgery)
- Gender(Baseline, pre-surgery)
- Computed tomography (CT) scans(From enrollment to the end of follow-up at 2 weeks)
- Japanese Orthopaedic Association (JOA) score(From enrollment to the end of follow-up at 1 year)
- Medical comorbidity(Baseline, pre-surgery)
- Previous spinal surgery(Baseline, pre-surgery)
- Creatine kinase (CK)(From enrollment to the end of follow-up at 2 weeks)
- VAS (visual analogue scale) for lower back pain(From enrollment to the end of follow-up at 1 year)
- Postoperative hospital stays(Immediately after the discharge)
- Body mass index (BMI)(Baseline, pre-surgery)
- Smoking status(Baseline, pre-surgery)
- Alcohol status(Baseline, pre-surgery)
- Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)(From enrollment to the end of follow-up at 1 year)
- Magnetic resonance imaging (MRI)(From enrollment to the follow-up at 2 weeks)
- Modified MacNab criteria(From enrollment to the end of follow-up at 1 year)
- Age(Baseline, pre-surgery)
- Physical examination finding(Baseline, pre-surgery)
- Affected level(Baseline, pre-surgery)
- Symptoms duration(Baseline, pre-surgery)
研究者
研究点 (1)
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