Clinical Trial: A Comparison of Stryker Hybrid Arch Bars

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Comparison of Stryker Hybrid Arch Bars Versus Erich Arch Bars for Maxillomandibular Fixation of Mandibular Fractures: A Prospective Randomized Study

Brief Summary:

Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction).

The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing


Detailed Summary:
Sponsor: Emory University

Current Primary Outcome: Time to place archbars [ Time Frame: During initial admission and surgery ]

Time taken to place archbars


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fracture healing [ Time Frame: 6 weeks ]
    Radiographic healing
  • Complications (to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures) [ Time Frame: up to 6 weeks post operatively ]
    assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures


Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: October 25, 2014
Date Started: May 2015
Date Completion: December 2017
Last Updated: January 21, 2017
Last Verified: July 2016