Mandible Fracture
Conditions
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.
Interventions
DEVICEIMF Screws
stainless steel screws placed in bone
DEVICEErich Arch Bars
Surgical braces wired around teeth
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time | Time duration of placement of device in operating room | Time duration for the application of device, in minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intermaxillary Fixation Screws Use of Intermaxillary Fixation screws as a means to wire the jaws.
IMF Screws: stainless steel screws placed in bone | 2 |
| Erich Arch Bars Use of Erich Arch bars in the wiring of the jaws.
Erich Arch Bars: Surgical braces wired around teeth | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 3 |
Baseline characteristics
| Characteristic | Intermaxillary Fixation Screws | Erich Arch Bars | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Duration to Maxillomandibular Fixation (minutes) | 17 minutes | 40.3 minutes | 28.7 minutes |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Time
Time duration for the application of device, in minutes.
Time frame: Time duration of placement of device in operating room
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IMF Screws | Time | 17 minutes |
| Erich Arch Bars | Time | 40.3 minutes |