Status:
TERMINATED
Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
Lead Sponsor:
Christiana Care Health Services
Conditions:
Mandible Fracture
Eligibility:
All Genders
18-70 years
Phase:
NA
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 b...
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. Pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01876979
Start Date
July 1 2013
End Date
April 1 2015
Last Update
June 28 2017
Active Locations (2)
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1
Christiana Care Hospital
Newark, Delaware, United States, 19718
2
Wilmington Hospital
Wilmington, Delaware, United States, 19801