NCT02385695Unknown不适用
A Prospective Comparative Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
Qiang Zhou, MD. PhD.1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2015年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Range of Motion in Lumbar Spine
研究概览
简要总结
The purpose of this study is to compare outcomes of (i) surgical treatment with posterior dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in patients with multilevel lumbar degenerative disk disease.
详细描述
Study aims are:
- To evaluate superiority of Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in lumbar range of motion;
- To compare Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in functional outcomes as measured by change in Oswestry Disability Index;
- To compare radiological, clinical, patient-reported and, safety outcomes between the two surgical approaches.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age between 30 and 75 years inclusive
- •Radiographic evidence of multi-level lumbar disc degeneration disease
- •Scheduled for 2- or 3-level lumbar discectomy at levels from L1 to S1 with or without dynamic stabilization or fusion
- •Preoperative ODI ≥ 30%
- •Clinical symptoms consistent with diagnosis of lumbar DDD:
- •Radicular back or lower extremity pain and/or
- •Decreased muscular strength and/or
- •Abnormal sensation
- •Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment
排除标准
- •Cauda equina syndrome
- •Patients with other lumbar conditions that will, in the opinion of the investigator, interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
- •Osteoporosis defined as T-score ≤ -3.
- •BMD will be measured by DEXA performed on lumbar spine
- •Systemic infection such as AIDS and active hepatitis
- •Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance, which may impact the outcome or study participation
- •Participation in a clinical trial of investigational drug or device within the past 30 days
结局指标
主要结局
Range of Motion in Lumbar Spine
时间窗: 24 Months
次要结局
- Change in Oswestry Disability Index(24 Months)
研究者
Qiang Zhou, MD. PhD.
Deputy Chair of the Department of Orthopedics, Chair of the Department of Spine Surgical Group
Third Military Medical University
研究点 (1)
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