An interventional study of Stryker Hybrid and Erich in Fracture Mandible, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
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
84 studies on the registry are indexed under Mandibular Fractures; 20 are open to participants now.
This study's enrollment of 50 is above the median of 22 across 64 interventional studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.
Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Placement of Hybrid arch bars for open or closed reduction of mandible fractures
Device: Stryker Hybrid
Placement of Erich archbars for open or closed reduction of mandible fractures
Device: Erich
Place Hybrid arch bars
Control group is Erich arch bars
Time to Place Archbars
Time taken to place archbars
Time frame: During initial admission and surgery
Number of Participants With Fracture Healing at 6 Weeks
Radiographic healing
Time frame: 6 weeks
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
| Milestone | Hybrid | Erich |
|---|---|---|
| Started | 26 | 24 |
| Completed | 26 | 24 |
| Not completed | 0 | 0 |
Time taken to place archbars
| minutes | Hybrid | Erich |
|---|---|---|
| Time to Place Archbars | 14.07 ± 8.4 | 37.29 ± 15.1 |
Radiographic healing
| Participants | Hybrid | Erich |
|---|---|---|
| Number of Participants With Fracture Healing at 6 Weeks | 18 | 18 |
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
| Participants | Hybrid | Erich |
|---|---|---|
| Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures | 5 | 0 |
Collected over 6 weeks post baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hybrid | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Erich | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | Hybrid | Erich | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 26 | 24 | 50 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Hybrid | Erich | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 22 | 20 | 42 |
| Race (NIH/OMB)(Participants) | Hybrid | Erich | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 21 | 17 | 38 |
| White | 5 | 7 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Hybrid | Erich | Total |
|---|---|---|---|
| United States | 26 | 24 | 50 |
Documents are hosted by the registry — open the source record to download them.
The record gives a start of May 2015, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 1 year after primary completion.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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