Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
研究概览
简要总结
The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.
详细描述
Lumbar disc herniations are quite common and typically improve after surgical correction. However, some patients develop recurrent herniations at the same level. Controversy exists as to why reherniated discs occur. Moreover, existing research does not settle the issue of whether a second decompression/discectomy or a repeat decompression/discectomy with pedicle screw fusion is the more successful treatment. This study is designed to compare differences in patient-reported pain, physical function, and satisfaction between the two types of surgery patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent lumbar disc herniation by MRI or CT with history of decompression at the same level in the past
- •Recurrent symptomatic history (with or without back pain) with radicular leg pain that improved following the first surgery
- •Male or female 18-75 years old
- •Flexion and extension x-rays that demonstrate an absence of sponylolisthesis or spondylolisthesis with less than 3 mm of movement
排除标准
- •Recurrence of disc herniation within 3 months of first decompression
- •Multiple level herniated discs
- •No history of lumbar back surgery except as in Inclusion criteria above
- •Documented severe osteoporosis or osteopenia
- •Symptoms of low back pain only
- •Diabetes mellitus
- •Patients with suspected or diagnosed psychological/psychiatric problems that could compromise the reliability of their results
- •Lumbar spondylolisthesis on flexion/extension x-rays > 3 mm
- •History of lumbar spine fractures (new or old)
- •Any concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
- •Autoimmune diseases
- •Age less than 18 or greater than 75 years
研究者
Michelle McFarland, MPH, CHRC
Manager - Mercy Research
Mercy Research