Objective Assessment of Vestibular Function Outcome After Cartilage Cap Occlusion Surgery for Dehiscent Superior Semicircular Canal
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- objective improvement
研究概览
简要总结
The primary objective of this study is to measure objective, functional outcomes of patients undergoing cartilage cap occlusion surgery for a dehiscent superior semicircular canal.
详细描述
One option for managing a dehiscent superior semicircular canal is surgical intervention. One of the surgical techniques is the transmastoid and tegmen mini-craniotomy cartilage cap occlusion of the dehiscent superior semicircular canal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ambulatory
- •independent self-sufficient adults
- •good general health
- •medically stable
排除标准
- •Medically unstable
研究组 & 干预措施
Surgical Group
patients will undergo a primary transmastoid and tegmen mini-craniotomy cartilage cap occlusion surgery.
干预措施: cartilage cap occlusion surgery (Procedure)
Non Surgical Group
patients meet the same criteria but will elect not to undergo surgery
结局指标
主要结局
objective improvement
时间窗: baseline to 3 months
The primary outcome measure will be the subsequent (3 month) FGA scores between the control group and the surgery group to assess any objective improvement attributable to surgery
次要结局
- ABC Scale(baseline to 3 months)
- VAS scores(baseline to 3 months)