Fracture Mandible
Conditions
Brief summary
Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction). The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing
Interventions
DEVICEStryker Hybrid
Place Hybrid arch bars
DEVICEErich
Control group is Erich arch bars
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis 2. Age 18 years - 90 years 3. Ability to give informed consent 4. Minimum 6 weeks follow-up 5. Pre and post-operative panoramic xrays
Exclusion criteria
1. Comminuted fractures 2. Infected fractures 3. Previously treated fractures 4. Complete edentulism 5. Gun shot wounds 6. Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Place Archbars | During initial admission and surgery | Time taken to place archbars |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fracture Healing at 6 Weeks | 6 weeks | Radiographic healing |
| Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures | up to 6 weeks post operatively | assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hybrid Placement of Hybrid arch bars for open or closed reduction of mandible fractures
Stryker Hybrid: Place Hybrid arch bars | 26 |
| Erich Placement of Erich archbars for open or closed reduction of mandible fractures
Erich: Control group is Erich arch bars | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | Hybrid | Erich | 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 | 26 Participants | 24 Participants | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 17 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 7 Participants | 12 Participants |
| Region of Enrollment United States | 26 participants | 24 participants | 50 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
Time to Place Archbars
Time taken to place archbars
Time frame: During initial admission and surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hybrid | Time to Place Archbars | 14.07 minutes | Standard Deviation 8.4 |
| Erich | Time to Place Archbars | 37.29 minutes | Standard Deviation 15.1 |
Secondary
Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures
assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures
Time frame: up to 6 weeks post operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hybrid | Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures | 5 Participants |
| Erich | Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures | 0 Participants |
Secondary
Number of Participants With Fracture Healing at 6 Weeks
Radiographic healing
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hybrid | Number of Participants With Fracture Healing at 6 Weeks | 18 Participants |
| Erich | Number of Participants With Fracture Healing at 6 Weeks | 18 Participants |