Pre-drilling or Self Drilling External Fixation Pins

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT01046747
First received: January 8, 2010
Last updated: January 11, 2010
Last verified: August 2009
  Purpose

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.


Condition Intervention
Fracture
Dislocation
Procedure: Placement of external fixation pins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pre-drilling Pilot Holes for Self-drilling Schanz Pins: Does it Reduce the Incidence of Pin Tract Infection and Pin Loosening?

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • pin tract infection [ Time Frame: until pins are removed ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pre-drill
These pins will be pre-drilled
Procedure: 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.
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
Procedure: 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.

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  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046747

Contacts
Contact: John R Fowler, MD 215-707-4545 fowler@temple.edu

Locations
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: John R Fowler, MD    215-707-4545      
Sub-Investigator: John R Fowler, MD         
Principal Investigator: Saqib Rehman, MD         
Sub-Investigator: Siddarth Joglekar, MD         
Sub-Investigator: Joe Dwyer, MD         
Sponsors and Collaborators
Temple University
  More Information

Publications:
Responsible Party: John R Fowler, M.D., Temple University School of Medicine
ClinicalTrials.gov Identifier: NCT01046747     History of Changes
Other Study ID Numbers: IRB - 12415 Pin Study
Study First Received: January 8, 2010
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
external fixation
pin tract infection
self drilling

Additional relevant MeSH terms:
Dislocations
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 25, 2014