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OpenTrials
Completed

NCT Number: NCT02283528

A Comparison of Stryker Hybrid Arch Bars

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

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Key information

Conditions

Fracture Mandible Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Mandibular Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Memorial Hospital

Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Comminuted fractures
  • Infected fractures
  • Previously treated fractures
  • Complete edentulism
  • Gun shot wounds
  • Pregnancy or breast feeding

Treatment and study plan

Stryker Hybrid

Device

Place Hybrid arch bars

Erich

Device

Control group is Erich arch bars

Primary outcomes

  1. Time to Place Archbars

    Time frame: During initial admission and surgery

    Time taken to place archbars

Secondary outcomes

  1. Number of Participants With Fracture Healing at 6 Weeks

    Time frame: 6 weeks

    Radiographic healing

  2. 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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Acronym: Hybrid

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2014
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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