Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.

Study Overview
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Brief Summary
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Determining the cost effectiveness, based on the time duration of application, of two methods of wiring the jaws together during surgery to repair mandible fractures. One technique is more expensive but faster in application, while the other is less expensive and takes more time to apply.

Detailed Description
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Purpose: To identify which option of wiring the jaws together during treatment of mandible fractures is more cost effective to the patient, Erich arch bars or IMF (Intermaxillary Fixation) screws. Patients who sustain mandible fractures that meet the inclusion criteria will be randomized to one of the two treatment types listed above. The overall treatment in both categories is consistent with the standard of care, the only difference being the method utilized to achieve intermaxillary fixation during the course of the surgery.

Official Title
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Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?

Conditions
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Mandible Fracture

Intervention / Treatment
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* Device: IMF Screws
* Device: Erich Arch Bars


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-70 Patients with no greater than one (1) open fracture of the tooth-bearing mandible Mandibular angle fractures ± Ramus or subcondylar fracture Body/symphysis ± subcondylar Isolated angle fracture Isolate subcondylar fractures Bilateral subcondylar fractures Any condylar head/neck fracture requiring treatment Patients who are candidates for treatment of their fractures in the operating room setting Exclusion Criteria: Patients younger than 18 or older than 70 Patients with developing tooth buds anterior to the second molars Patients with inadequate stability of occlusion Edentulism Unstable vertical and horizontal stops to the occlusion Patients with disorders affecting bone healing, metabolism and turnover Those patients on bisphosphonates, oral or IV Patients with evidence of intrabony pathology of the mandible or maxilla The presence of any of the following: Greater than one (1) open fracture of the tooth-bearing mandible Bilateral angle fractures are exempt from this Comminuted fractures of the mandible Concomitant infection, or osteomyelitis of the mandible Mechanism of injury Pathologic fracture Gun-shot wounds

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IMF Screws<br>Use of IMF screws as a means to wire the jaws. | Device: IMF Screws<br>* stainless steel screws placed in bone<br>* Other names: Synthes IMF screws;|
| Active Comparator: Erich Arch Bars<br>Use of Erich Arch bars in the wiring of the jaws. | Device: Erich Arch Bars<br>* Surgical braces wired around teeth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | Time duration for the application of device, in minutes. | Time duration of placement of device in operating room |