Pre-drilling or Self Drilling External Fixation Pins

NCT01046747 | Unknown DMC

• 1 other identifier: IRB - 12415 Pin Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

external fixation; pin tract infection; self drilling

Outcome Measures

Primary Outcomes (1)

• pin tract infection

  until pins are removed

Study Arms (2)

Pre-drill

ACTIVE COMPARATOR

These pins will be pre-drilled

Procedure: Placement of external fixation pins

No pre-drill

ACTIVE COMPARATOR

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

Interventions

Placement of external fixation pins PROCEDURE

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.

No pre-drill; Pre-drill

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Related Publications (7)

• Abouzgia MB, Symington JM. Effect of drill speed on bone temperature. Int J Oral Maxillofac Surg. 1996 Oct;25(5):394-9. doi: 10.1016/s0901-5027(06)80040-8.

  PMID: 8961026 BACKGROUND

• 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.

  PMID: 18982187 BACKGROUND

• 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. doi: 10.1016/s1350-4533(01)00016-9.

  PMID: 11334754 BACKGROUND

• Bonfield W, Li CH. The temperature dependence of the deformation of bone. J Biomech. 1968 Dec;1(4):323-9. doi: 10.1016/0021-9290(68)90026-2. No abstract available.

  PMID: 16329435 BACKGROUND

• 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(5):717-21. doi: 10.2106/00004623-200105000-00010.

  PMID: 11379741 BACKGROUND

• 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. doi: 10.1016/0363-5023(91)90033-8.

  PMID: 1861045 BACKGROUND

• 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. doi: 10.2106/JBJS.G.00425. No abstract available.

  PMID: 17606806 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Joint Dislocations

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

John R Fowler, MD

CONTACT

215-707-4545; fowler@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Last Updated: January 12, 2010

Record last verified: 2009-08

Locations

US (1)