A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study)

J Orthop Trauma. 2017 Apr:31 Suppl 1:S10-S17. doi: 10.1097/BOT.0000000000000804.

Abstract

The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Equipment Failure Analysis
  • External Fixators / economics*
  • External Fixators / statistics & numerical data
  • Female
  • Fractures, Open / economics*
  • Fractures, Open / epidemiology
  • Fractures, Open / surgery*
  • Health Care Costs / statistics & numerical data
  • Humans
  • Internal Fixators / economics*
  • Internal Fixators / statistics & numerical data
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Prevalence
  • Prosthesis Design
  • Risk Factors
  • Surgical Wound Infection / diagnosis
  • Surgical Wound Infection / economics*
  • Surgical Wound Infection / epidemiology
  • Tibial Fractures / economics*
  • Tibial Fractures / epidemiology
  • Tibial Fractures / surgery*
  • Trauma Severity Indices
  • Treatment Outcome
  • United States / epidemiology
  • Young Adult