Recruiting

Pre-drilling vs. No Pre-drilling

Sponsor:

Temple University

Code:

NCT01046747

Conditions

Fracture

Dislocation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placement of external fixation pins

Study Details

Brief summary:

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.

Conditions

Fracture

Dislocation

Study ID

NCT01046747

Start date

Jul, 2009

Status verified date

Aug, 2009

Primary completion date

Aug, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pre-drill

These pins will be pre-drilled

active comparator: No pre-drill

these pins will not be pre-drilled, but will rely on the self drilling function of the pin for insertion

Interventions

Placement of external fixation pins

The fractures will be treated according to standard of care. If the external fixation is to be used as a staging procedure, then this will be removed and an internal fixation procedure will be performed. The pin sites will be checked daily according to standard of care. All individuals involved in the examination of the pin sites will receive a standardized training in the grading of pin tract infection and loosening. Each pin site will be graded individually by three persons to evaluate internal accuracy of our grading. Pin tract infections will be first graded as yes or no, and then graded according to the Modified Joglekar Classification (Grade 0-4, Grade 0: no erythema, no drainage; Grade 1: erythema, no drainage OR no erythema with serous drainage; Grade 2: erythema, serous drainage; Grade 3: erythema, purulent drainage; Grade 4: gross pin loosening). Pin loosening will be evaluated at the time of pin removal and graded as either yes or no.

Primary outcome measure

  • pin tract infection [ Time Frame: until pins are removed ]

Central Contacts and Locations

Central contacts

John R Fowler, MD

215-707-4545fowler@temple.edu

Locations

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

John R Fowler, MD

215-707-4545

Principal Investigator:

Saqib Rehman, MD

More Information

Sponsor

Temple University

Last update posted

Jan 12, 2010

Last verified

Aug, 2009

Keywords

  • external fixation
  • pin tract infection
  • self drilling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2010-01-12.