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N/A N=50 Randomized Treatment

A Comparison of Stryker Hybrid Arch Bars

Fracture Mandible

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Time to Place Archbars — 14.07; 37.29 minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Stryker Hybrid (Device); Erich (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Emory University
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Place Archbars
14.07; 37.29
SECONDARY
Number of Participants With Fracture Healing at 6 Weeks
18; 18
SECONDARY
Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures
5; 0

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

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02283528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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