N/A
N=50
A Comparison of Stryker Hybrid Arch Bars
Fracture Mandible
Bottom Line
View on ClinicalTrials.gov: NCT02283528 ↗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
| Outcome | Result | p-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
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.