Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pin Complications
研究概览
简要总结
The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.
详细描述
Halo Thoracic Orthoses (Halos) are used to immobilise unstable cervical fractures. The halo grips the skull via 4 pins. Pin loosening is a major complication of halo wear. Pin loosening is painful and can result in loss of control of the fractures. Treatment is required urgently and involves re-siting the pin.
Comparisons: This study will compare two pin management practises with the aim to determine which is optimal to reduce the incidence of complications including pin loosening. Patients will be randomly allocated into 2 groups. The control group will receive treatment in accordance with current practise at The Alfred, the pins will not be re-tensioned throughout the treatment period. The alternative treatment group will have their pins re-tensioned fortnightly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Must be fitted with a Halo Thoracic Orthosis at The Alfred Hospital
排除标准
- •Patients who can not have their halo pins tensioned to at least 8lb/inch pressure.
结局指标
主要结局
Pin Complications
时间窗: Treatment duration (approx 12 weeks)
Pins classified at each follow-up as OK, At Risk, Loose, Moderate or Severe Infection
次要结局
- Anxiety Text(Fortnightly)
- Pain(Fortnightly)
- Pin Tension Measurements(Fornightly)