Pre-drilling or Self Drilling External Fixation Pins
Status unconfirmed · Not applicable
Conditions studied: Fracture, Dislocation
In brief
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.
Key facts
- Study ID
- NCT01046747
- Run by
- Temple University
- People needed
- 100
- Starts
- 2009-07-01
- Last updated by the study team
- 2010-01-12
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-89
- Fluency in spoken/ written English/ Spanish (consent form in Spanish will be needed)
- Lower extremity fracture/ dislocation treated with an external fixator
You may not qualify if…
- Prisoners
- 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.
Where it is running
- Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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