Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The difference in radiographic union
研究概览
简要总结
The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 85 years
- •Stable Tibial fracture recommended for surgical intervention
排除标准
- •Patients not meeting inclusion criteria
- •Unstable fracture patterns e.g. those needing a secondary intervention - masquelet/cement spacer)
- •Previously non-ambulatory patients
- •Delayed presentation of fracture (>4 weeks)
- •Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability
- •Patients with an achieve infection or wound at the surgical site
- •Any previous ligament or fracture surgery on the index site
- •Inflammatory rheumatic disease or other rheumatic disease-
- •Immune compromised patients (hepatitis, HIV, etc.)
- •Unwilling or unable to participate or follow study protocol
研究组 & 干预措施
Micromotion Cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
干预措施: micromotion intramedullary nail cohort (Procedure)
Standard Cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw
干预措施: standard intramedullary nail cohort (Procedure)
结局指标
主要结局
The difference in radiographic union
时间窗: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively
bridging callus, minimum three cortices bridged
次要结局
- difference in complication rates(1 year post-operatively)
研究者
Joseph Johnson
Associate Professor
University of Alabama at Birmingham