Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
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|ClinicalTrials.gov Identifier: NCT01876979|
Recruitment Status : Terminated (Extended study duration)
First Posted : June 13, 2013
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mandible Fracture||Device: IMF Screws Device: Erich Arch Bars||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Active Comparator: IMF Screws
Use of IMF screws as a means to wire the jaws.
Device: IMF Screws
stainless steel screws placed in bone
Other Name: Synthes IMF screws
Active Comparator: Erich Arch Bars
Use of Erich Arch bars in the wiring of the jaws.
Device: Erich Arch Bars
Surgical braces wired around teeth
- Time [ Time Frame: Time duration of placement of device in operating room ]Time duration for the application of device, in minutes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876979
|United States, Delaware|
|Christiana Care Hospital|
|Newark, Delaware, United States, 19718|
|Wilmington, Delaware, United States, 19801|
|Principal Investigator:||Daniel Meara, MD||Christiana Care Health Services|
|Study Chair:||Daniel J Meara, MS, MD, DMD||Christiana Care Health Services|