Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness
Determining the cost effectiveness 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Cost Effective in the Operating Room Setting?|
- Cost [ Time Frame: Duration of placement of device in operating room ] [ Designated as safety issue: No ]Duration of application of device in minutes multiplied by cost of operating room expenses in dollars per minute. This total added to the cost of the device.
|Study Start Date:||July 2013|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01876979
|United States, Delaware|
|Christiana Care Hospital|
|Newark, Delaware, United States, 19718|
|Wilmington, Delaware, United States, 19801|
|Principal Investigator:||Geoffrey Zinberg, DMD||Christiana Care Health Services|
|Study Chair:||Daniel J Meara, MS, MD, DMD||Christiana Care Health Services|