跳至主要内容
临床试验/NCT03439228
NCT03439228招募中不适用

To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial

Hamilton Health Sciences Corporation2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月16日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验