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

Christiana Care Health Services5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Mandible Fracture

Interventions

IMF ScrewsDEVICE

stainless steel screws placed in bone

Erich Arch BarsDEVICE

Surgical braces wired around teeth

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Christiana Care Hospital

Newark, Delaware, United States

Wilmington Hospital

Wilmington, Delaware, United States

Outcomes

Primary Outcomes

Time

Time duration for the application of device, in minutes.

Time frame: Time duration of placement of device in operating room

Data from ClinicalTrials.gov

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