A Comparison of Stryker Hybrid Arch Bars

Study Overview
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Brief Summary
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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

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

Conditions
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Fracture Mandible

Intervention / Treatment
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* Device: Stryker Hybrid
* Device: Erich


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Place Archbars | 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 | Radiographic healing | 6 weeks | 
| Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures | 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 |