Evaluation of Bisphosphonate Coated Pins for Extern Fixation in Tibia Osteotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical mode.
研究概览
简要总结
The purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model.
详细描述
The pin fixation and the risk for pin loosening and pintract infection is intimately connected Moroni et al., Magyar et al. Toksvig-Larsen and W-Dahl) The pin performance ratio for insertion to extraction torque (PPI) varies significantly between screw types.
The extraction torque force is the most important value and it is estimated that a removal torque around 300 Nm probably will be the best bon-pin fixation in clinical practice.
In animal studies and even in clinical studies the hydroxyapatite (HA) coated screw retained the highest level of osseointegration. However, the fixation for HAscrews is, especially in diaphyseal bone, the risk for too tight fixation, with extreme difficulties to remove the screws in few cases as a result ( high pain and seldom it is impossible to remove the screw) Coating by biphosphonate is a new novel technique with preclinical appealing performance, which theoretically should make this coating very appealing in clinical practice. The theory behind this technique is that it create a good pinfixation reasonable easy to remove.
The current most used cortical screw designs performed poorest in terms of fixation (PPI)
Method
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
- Double (Participant, Outcomes Assessor)
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
- •All patients which are diagnosed with arthr and needs an operation.
排除标准
- 未提供
结局指标
主要结局
To evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical mode.
时间窗: 2011-07-01-2012-02-01
To evaluate the relative osseomechanical strength of a novel coated pin/screw
次要结局
未报告次要终点
