Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Score on Pain Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. In this study, the team will compare patient related outcomes and comfort for each method of initial management of humeral shaft fractures. Participant pain, narcotic usage, and function will be tracked over a 2 week period to see which method of immobilization is preferred.
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
- 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
- 否
入选标准
- •Presenting to an emergency room or ICARE in the participating centers with an acute humeral shaft fracture
- •Age above 18 and skeletally mature
- •Isolated Injury
- •Treated non-operatively first 2 weeks
排除标准
- •Open fractures
- •Poly trauma
- •Injuries deemed operative by attending surgeon
- •Patients undergoing treatment for malignancy
结局指标
主要结局
Score on Pain Visual Analogue Scale (VAS)
时间窗: Week 2 post-treatment
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The total range of score is 0 (no pain) to 10 (unbearable pain); the higher the pain, the greater the amount of pain.
Number of Tramadol Pills Taken
时间窗: Week 2 post-treatment
All patients will be discharged with 28 pills of tramadol 50mg. At week 2 follow-up, number of tramadol pills taken will be reported.
次要结局
- Incidence of cutaneous complications(Week 2 post-treatment)
- Score on PROMIS - Physical Function - Short Form 10b(Week 2 post-treatment)