Fracture Clinical Trial
Official title:
Pre-drilling Pilot Holes for Self-drilling Schanz Pins: Does it Reduce the Incidence of Pin Tract Infection and Pin Loosening?
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-89 2. Fluency in spoken/ written English/ Spanish (consent form in Spanish will be needed) 3. Lower extremity fracture/ dislocation treated with an external fixator Exclusion Criteria: 1. Prisoners 2. Patients unable to give informed consent 3. Patients who require that pins be placed without skin coverage at the pin site 4. Patients receiving Ilizarov or other circular external fixators with transfixing wires. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Temple University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University |
United States,
Abouzgia MB, Symington JM. Effect of drill speed on bone temperature. Int J Oral Maxillofac Surg. 1996 Oct;25(5):394-9. — View Citation
Antoci V, Ono CM, Antoci V Jr, Raney EM. Pin-tract infection during limb lengthening using external fixation. Am J Orthop (Belle Mead NJ). 2008 Sep;37(9):E150-4. — View Citation
Bachus KN, Rondina MT, Hutchinson DT. The effects of drilling force on cortical temperatures and their duration: an in vitro study. Med Eng Phys. 2000 Dec;22(10):685-91. — View Citation
Bonfield W, Li CH. The temperature dependence of the deformation of bone. J Biomech. 1968 Dec;1(4):323-9. — View Citation
Moroni A, Faldini C, Marchetti S, Manca M, Consoli V, Giannini S. Improvement of the bone-pin interface strength in osteoporotic bone with use of hydroxyapatite-coated tapered external-fixation pins. A prospective, randomized clinical study of wrist fractures. J Bone Joint Surg Am. 2001 May;83-A(5):717-21. — View Citation
Seitz WH Jr, Froimson AI, Brooks DB, Postak P, Polando G, Greenwald AS. External fixator pin insertion techniques: biomechanical analysis and clinical relevance. J Hand Surg Am. 1991 May;16(3):560-3. — View Citation
Ziran BH, Smith WR, Anglen JO, Tornetta P 3rd. External fixation: how to make it work. J Bone Joint Surg Am. 2007 Jul;89(7):1620-32. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pin tract infection | until pins are removed | No |
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