Clinical trial NCT01876979: Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
Official title: Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mandible Fracture
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time
timeFrame: Time duration of placement of device in operating room
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Hospital
state: Delaware
city: Wilmington
country: United States
facility: Wilmington Hospital
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Daniel Meara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Services
name: Daniel J Meara, MS, MD, DMD
role: STUDY_CHAIR
References: