To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of study completion
研究概览
简要总结
The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single-level lumbar instrumented postero-lateral fusion from L2-L5
- •Life expectancy greater than 2 years
排除标准
- •Previous lumbar surgery
- •Spine tumour/cancer
- •Documented osteoporosis
- •High grade (3 or 4) spondylolisthesis
结局指标
主要结局
Rate of study completion
时间窗: 12 months
Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.
Rate of enrolment
时间窗: 12 months
Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.
次要结局
- Functional Status(3 months, 6 months, 12 months)
- Pain Status(3 months, 6 months, 12 months)
- Lumbar bone fusion(12 months)
