The Effect of Autologous Bone Marrow Concentration on Femoral Shaft Fracture Union
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1-month postoperative degree of union evaluated by plain radiograph
研究概览
简要总结
This study aims to evaluate the effect of bone marrow concentration on union of femoral shaft fracture by comparing clinical and imaging outcomes between patients receiving Intramedullary nail fixation with intraoperative bone marrow concentration and those receiving Intramedullary nail fixation only.
详细描述
Femoral shaft fracture is a common orthopaedic injury. Intramedullary nail is one of the standard treatments. Its primary goal is to develop an osseous bridge between adjacent motion segments to prevent motion, relieve pain, and facilitate bone union. Delayed union or nonunion is common in femoral shaft fracture. Risk factors include comminuted fracture, open fracture, smoking, diabetes and open reduction of fracture fixation. Mesenchymal stem cells are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve bone healing. Therefore, the goal of this study was to evaluate the effect of bone marrow concentration on union of femoral shaft fracture.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With recent diagnosis of femoral shaft fracture
- •Treated with intramedullary nail fixation
- •With one or more risk factors of non-union: comminuted fracture, open fracture, smoking, obesity, diabetes, open reduction,
- •Age between 20 and 80 years
排除标准
- •Old femoral shaft fracture
- •With concurrent major trauma, ex. intracranial hemorrhage, pneumothorax, hemothorax, internal bleeding.
- •With prior history of femoral surgery
- •With current or prior history of trauma or infection at femur
- •With current diagnosis of coagulopathy
- •With current or prior history of cancer
- •With current or prior history of hematological disease
- •Pregnancy
- •Patients who will not cooperate with one-year followup
结局指标
主要结局
1-month postoperative degree of union evaluated by plain radiograph
时间窗: 1-month postoperative
Degree of union evaluated by plain radiograph
次要结局
- 2-month postoperative degree of union evaluated by plain radiograph(2-month postoperative)
- 3-month postoperative degree of union evaluated by plain radiograph(3-month postoperative)
- 6-month postoperative degree of union evaluated by plain radiograph(6-month postoperative)
- 12-month postoperative degree of union evaluated by plain radiograph(12-month postoperative)
研究者
Pei-Yuan Lee, MD
Principal Investigator
Show Chwan Memorial Hospital