Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 32
- 主要终点
- Necessity for additional operation
研究概览
简要总结
The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.
详细描述
Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fractured tibia requiring fixation using an intramedullary nail
排除标准
- 未提供
研究组 & 干预措施
1
Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail.
干预措施: Intramedullary nail implant (Procedure)
2
Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal.
干预措施: Intramedullary nail implant (Procedure)
结局指标
主要结局
Necessity for additional operation
时间窗: Months 6, 9, and 12
次要结局
- Return to work, functional status, and health-related quality of life(Months 6, 9, and 12)