A Comparison of Stryker Hybrid Arch Bars (Hybrid)

January 11, 2019 updated by: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Grady Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
  2. Age 18 years - 90 years
  3. Ability to give informed consent
  4. Minimum 6 weeks follow-up
  5. Pre and post-operative panoramic xrays

Exclusion Criteria:

  1. Comminuted fractures
  2. Infected fractures
  3. Previously treated fractures
  4. Complete edentulism
  5. Gun shot wounds
  6. Pregnancy or breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid
Placement of Hybrid arch bars for open or closed reduction of mandible fractures
Device: Stryker Hybrid
Place Hybrid arch bars
Active Comparator: Erich
Placement of Erich archbars for open or closed reduction of mandible fractures
Device: Erich
Control group is Erich arch bars

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Place Archbars
Time Frame: During initial admission and surgery
Time taken to place archbars
During initial admission and surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Fracture Healing at 6 Weeks
Time Frame: 6 weeks
Radiographic healing
6 weeks
Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or 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
up to 6 weeks post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 21, 2017

Study Completion (Actual)

December 21, 2017

Study Registration Dates

First Submitted

October 25, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00076048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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