NCT00791180已完成不适用
Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Clinical Outcomes
研究概览
简要总结
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System. Secondary purpose of this study is to assess outcomes with historical controls along a continuum of motion and anatomy sparing procedures.
详细描述
This study will help the patient to the extent that it will allow the comparison of this unique treatment to the corpus of literature on radicular pathology, thus focusing a specific treatment for a specific pathology.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spondylolisthesis of less than Grade II at the index level (degenerative with intact pars)
- •Will receive a decompression for lumbar stenosis
- •Symptoms of leg and/or back pain
- •One pathological level
- •Between the ages of 20 and 80 at the time of surgery
- •Non-responsive to non-surgical treatment for at least six months
排除标准
- •Osteolytic spondylolisthesis
- •Planned complete facetectomy
- •Two or more pathological levels (and as enumerated int he Dynesys Spinal system instructions for use)
- •Use in the cervical spine
- •Active systemic or local infection
- •Extreme obesity as defined by a Body Mass Index (BMI)over
- •BMI calculated using Appendix A, adapted from the National Heart, Lung, and Blood Institute, Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.
- •Pregnancy
- •Mental illness
- •Severe osteoporosis or osteopenia. The World Health Organization defines osteoporosis as BMD<-2.5t. Professional discretion should be used and if bone quality is in question a DEXA scan is recommended.
- •Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
- •Alcohol or drug abuse
- •Patient unwilling or unable to follow postoperative instructions
- •Soft tissue deficit not allowing sound closure
- •Any medical or physical condition that would preclude the potential benefit of spinal surgery
- •Inadequate pedicles of the lumbar or sacral vertebrae; congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of othe devices;
- •Any medical or mental condition which would exclude the patient at high risk from surgery of the severity
结局指标
主要结局
Clinical Outcomes
时间窗: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months
次要结局
- Surgical Outcomes(Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months)
研究者
研究点 (1)
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