Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of ⦠(NCT01876979) | Clinical Trial Compass
TerminatedNot Applicable
Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
Stopped: Extended study duration
United States5 participantsStarted 2013-07
Plain-language 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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Time
Timeframe: Time duration of placement of device in operating room