Pre-drilling Pilot Holes for Self-drilling Schanz Pins: Does it Reduce the Incidence of Pin Tract Infection and Pin Loosening?
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- pin tract infection
研究概览
简要总结
Hypothesis
There is no difference in the incidence of pin tract infection and pin loosening in case of lower extremity external fixators when self-drilling schanz pins are used with or without pre-drilling.
Primary Objective
The primary objective is to determine whether pre-drilling holes for external fixation pin insertion is superior to not pre-drilling holes for external fixation pin insertion in regards to the incidence of pin tract infection and pin loosening.
Secondary Objective
If any difference is found between the two techniques then, we will quantify and qualify those differences. The incidence of pin site infection and pin loosening in general will be determined and will also be stratified for site and size of pin. An attempt to identify risk factors for pin site infection will be made by observing the effect of secondary prognostic factors like mode of injury, diabetes, smoking, compartment syndrome, peripheral vascular disease, neurovascular injury. Interobserver reliability of the grading system for pin infection will also be determined.
详细描述
Background
The application of external fixation is a commonly performed emergency procedure in orthopaedics for temporary stabilization as well as definitive treatment of fractures. External fixation requires that metal pins be placed into the bone on either side of the fracture. The pins are then connected to an external frame, thus stabilizing the fracture. There is debate over the optimal technique for the insertion of these pins in regards to the need to pre-drill a pilot hole prior to pin insertion.
The technology behind external fixation has evolved greatly over the past thirty years. The original external fixation pins, "Shanz pins," were essentially metal rods with threads and a trocar point. A pilot hole was needed because these pins did not have the capability to create their own hole or path in the bone. Recent advances have lead to the creation of self-drilling/self-tapping pins, which have decreased the number of steps necessary to place the pins and thereby decreased operative time. The external fixators are usually placed as a temporary measure to allow for improvement of soft tissue condition before definitive open reduction and internal fixation. Since many external fixation devices are placed in patients who are critically ill, decreasing operative time is very important.
While saving operative time is essential it is also important that the device serves its purpose without leading to complications in the short term. The major complications related to external fixation are pin site infection and pin loosening. The literature is clear that high temperatures created during pin insertion leads to bone necrosis surrounding the pin, increased infection, and increased rates of loosening. It is unclear if the new generation self-drilling pins create the same amount of necrosis as the older generation of pins. Lab studies have shown increased temperatures with direct drilling with these pins as compared to pin insertion after drilling pilot holes with dedicated drill bits. It is unclear if this increased temperature results in increased rate of loosening or pin site infection in clinical practice.
A thorough literature search has revealed no randomized controlled studies to support the use of these pins without drilling pilot holes before insertion. The current standard of care is undefined and left to surgeon preference. Our study aims to provide guidelines for schanz pin insertion for external fixator application, which may help to reduce the number of pin tract infections suffered by patients and improve 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 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluency in spoken/ written English/ Spanish (consent form in Spanish will be needed)
- •Lower extremity fracture/ dislocation treated with an external fixator
排除标准
- •Patients unable to give informed consent
- •Patients who require that pins be placed without skin coverage at the pin site
- •Patients receiving Ilizarov or other circular external fixators with transfixing wires.
结局指标
主要结局
pin tract infection
时间窗: until pins are removed
次要结局
未报告次要终点
