A Comparison of Stryker Hybrid Arch Bars Versus Erich Arch Bars for Maxillomandibular Fixation of Mandibular Fractures: A Prospective Randomized Study
Phase: NA
Conditions: Fracture Mandible
Sponsor: Emory University

IRB00076048  
NCT02283528 
 
A Comparison of Stryker Hybrid Arch Bars 
 versus Erich Arch Bars for Maxillomandibular 
Fixation of Mandibular Fractures:  
A Prospective Randomized Study 
 
 
 
 
 
Investigators: 
 
Gary F Bouloux 
MD, DDS, MDSc, FRACDS, FRACDS 
 
Shelly Abramowicz 
DMD, MPH 
 
 
 
 
01/27/2015 
 
 
 
 
 
 
 
 
 

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Schema:  
Consecutive patients presenting to Grady Memorial Hospital with mandibular fractures 
will be evaluated for recruitment in this pilot study. Patients requiring either open 
reduction and internal fixation (ORIF) or closed reduction (CR) will be included in the 
study. 
 
The choice of surgical method (ORIF versus CR) will be determined by the patient 
preference in conjunction with the attending surgeons expert opinion. The surgical 
procedure for closed treatment is a simple and standardized procedure involving 
placement of arch bars and maxillomandibular fixation (MMF) for a period of 4-6 weeks. 
The surgical procedure for ORIF will involve the placement of arch bars intraoperatively, 
exposure of fractures by intraoral or transcutaneous incisions, intraoperative MMF and 
ORIF. All procedures will be done under a general anesthesia. All eligible subjects will 
be initially stratified to ORIF or CR. Subjects within each group will then be randomized 
to either Stryker Hybrid arch bars or Erich arch bars (control). In all groups the arch bars 
will be left in place for six weeks. Stryker Hybrid arch bars will be placed according to 
the manufactures instruction using a minimum of four locking screws per arch. Erich 
arch bars will be placed using a combination of 24 and 25 gauge wire as is the historical 
technique. Arch bar removal is a simple procedure that will be completed under local 
anesthesia in the outpatient clinic. 
The primary predictor variable is the type of archbar (Stryker Hybrid versus Erich). 
The primary outcome variable is time required to place the arch bars. Secondary 
outcomes include union (nonunion, fibrous union, malunion), complications, hospital 
charges and need for additional procedures 
 
 
Introduction: 
 
Mandible fractures are commonly a result of maxillofacial trauma and account for the 
majority of facial fractures. The majority of fractures are treated with either ORIF or CR. 
Erich arch bars are the most commonly used type of MMF and are considered the gold 
standard. However, the application of Erich arch bars is time-consuming and requires 
the presence of teeth.  Intermaxillary fixation screws and IVY loops are alternative 
approaches that may also be used. The hybrid arch bar system developed by Stryker is 
unique in that the bars are secured to the underlying alveolar bone with self-drilling 
locking screws rather than the teeth. This potentially reduces the time required to place 
the arch bars as well as the need for teeth. 
There are is no studies comparing Stryker Hybrid arch bars to traditional methods of 
MMF.  
 

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Objectives 
 
1) Is there a difference in the application time when comparing Stryker hybrid 
arch bars to Erich arch bars for the ORIF or CR of mandibular fractures? 
2) Is there any difference in overall surgical time, postoperative length of stay, 
hospital charges, fracture healing or complications when comparing Stryker 
hybrid arch bars to Erich arch bars for the ORIF or CR of mandibular fractures? 
 
Patient Selection 
Patients presenting to Grady Memorial Hospital will be eligible for inclusion in the study.  
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 
 
Informed consent will be obtained on all patients. Any patient who declines to participate 
in this study will be treated in an identical fashion to those who enroll in this study other 
than the type of intra-operative MMF will be determined by the attending surgeon rather 
than randomized. 
 
Pretreatment Evaluation 
 
All patients will have a history and physical examination as part of their admission to 
Grady Memorial Hospital. All patients will have a panorex xray or maxillofacial CT scan 
to assess the severity and location of mandible fractures and other facial fractures, as is 
the standard of care. In addition to routine blood tests (complete blood count and 
metabolic panel), patients reporting diabetes in their history will have a hemoglobin A1c 
drawn. Patients reporting human immunodeficiency virus infection in their history will 
have a CD4 count drawn unless they have recent result (CD4 count within 6 months) or 

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refuse. This will allow the level of immunocompetence in patients with known diabetes 
or HIV to be evaluated and additional medical care (additional antibiotics, antifungals, 
opportunistic infection prophylaxis, strict blood glucose control etc.) to be provided as 
the standard of care.  
 
Registration and Randomization 
 
Eligible patients will be offered the opportunity to enroll in the study when they are first 
consulted by the oral and maxillofacial surgery service. Consent will be obtained by one 
of the study investigators. Subjects will then be randomized to either Stryker hybrid arch 
bars or Erich archbars group using sealed envelopes that have been prepared by the 
study statistician.  
 
Sample size 
No prior studies exist to guide sample size calculations. It is anticipated that this pilot 
study will include a total of 40 subjects in the CR arms and 60 subjects in the ORIF 
arms. This study will allow for a drop out rate 30% for the outcome variables which is 
consistent with the patient population based on prior studies. 
 
Therapy 
 
In the ORIF group, thirty patients will be randomized to each arm of the study (30 
Stryker hybrid arch bars and 30 Erich arch bars). In the CR group, twenty subjects will 
be randomized to each arm of the study (20 Stryker hybrid arch bars and 20 Erich arch 
bars). A number of different resident surgeons will perform the surgical treatment 
including the application of MMF. All residents will complete Stryker clinical skills 
training and will be standardized as the application process and technique for both arch 
bar systems. For all study subjects, time will be recorded from start to completion of 
maxillary and mandibular arch bar placement, and from insertion of throat pack to 
removal of throat pack.  This will me measure using two different electronic timers to 
record the respective times. All arch bars will be left in place (ORIF and CR) for a period 
of 6 weeks. Patients will be discharged from the hospital as soon as possible after 
medically stable from surgery. Patients will be seen for follow up routinely for a 
minimum of 6 weeks postoperatively to ensure appropriate healing.   
 
Patient Assessment 
 
Patients will be assessed during surgery and in the postoperative period while in the 
hospital. After discharge, patients will be followed routinely to ensure complete bony 
consolidation of the fracture and at 4 to 12  weeks postoperatively. The primary 

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outcome variable is application time for placement of arch bars. Secondary outcomes 
include intra-operative surgical time length of stay after surgical procedure, length of 
stay, hospital charges, fracture healing and complications. 
 
All data will be collected by the PI or CI during the initial admission for surgery to 
repair the fracture or at the one week and 6 week follow-up appointments. All data will 
be recorded on a standard data collection sheet. Subjects will have not have any 
questionnaires or surveys to complete. Demographic, preoperative, operative and 
postoperative variables will be recorded and analyzed. Demographic data includes age, 
sex and race. Preoperative variables include medical history (DM and HIV), social 
history, fracture location, number of fractures, time from injury to surgery and antibiotic 
use. Operative variables include time for arch bar application, surgical time and surgical 
approach. Post operative variables include fracture healing, follow-up, complications 
and hospital charges.  It is anticipated that the study will conclude at 24 months. All 
subjects will be paid $50 at the 4 to 12 week follow-up visit. 
 
Data Collection 
 
A data collection sheet will be used to record demographic, preoperative, operative and 
postoperative variables. A separate copy of the data collection sheet is attached. All 
data collection sheets (unscrubbed and scrubbed) will be kept in a locked office. All data 
will be entered into a computer and this will be both password protected and secured in 
a locked office. 
 
Data Safety Monitoring Plan 
 
The use of either Erich arch bars or Stryker Hybrid arch bars are both FDA approved 
and used in clinical practice routinely to immobilize the jaws due to fracture. They can 
immobilize the jaw for 4 to 6 weeks to allowing healing when open surgery is not 
indicated or wanted by the patient. They can also immobilize the jaw temporarily during 
surgery to allow the surgical placement of titanium plates and screws to repair the 
fracture. There are no anticipated risks for subjects recruited to this study. However to 
ensure safety of subjects the investigators have appointed Dr Guillermo Umpierrez MD 
as the medical monitor. The medical monitor responsibilities include 
 
 Pre-investigation discussion to verify understanding of the protocol, DSMB and 
IRB requirements.  
 Ensure that that eligibility and exclusion criteria are adhered to ensure the 
appropriate risk/benefit ratio for subjects. 
 Ensure written consent is obtained for each subject  
 

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 Ensure that subjects are 18 yrs of age, non-pregnant and not actively seeking to 
become pregnant, not breast feeding and are not disadvantaged populations.  
 Ensure that data on adverse outcomes is recorded appropriately in the surgical 
operative report and during the follow-up visits.  
 Provision for subject withdrawal and documentation for reasons of 
discontinuation. 
 Ensure that data is entered in real time to provide electronic access on a monthly 
basis.  
 Three Monthly conference with the investigators.  
 Review subject records periodically to ensure that data is accurate and legible. 
Of particular importance will be recognizing any data omission, missing visits or 
examinations, drop-out subjects and reasons for withdrawal and satisfactory 
completion of informed consent.  
 A written record of the teleconference and any site visits will be kept as well as 
any corrective action recommended by the monitor.  
 
 
Bibliography 
 
1. West GH, Griggs JA, Chandran R, Precheur HV, Buchanan W, Caloss R. Treatment 
outcomes with the use of maxillomandibular fixation screws in the management of 
mandible fractures. J Oral Maxillofac Surg. 2014 Jan;72(1):112-20.  
 
2. Bell RB, Wilson DM. Is the use of arch bars or interdental wire fixation necessary for 
successful outcomes in the open reduction and internal fixation of mandibular angle 
fractures? J Oral Maxillofac Surg. 2008 Oct;66(10):2116-22. 
 
3. Thor A, Andersson L. Interdental wiring in jaw fractures: Effects on teeth and 
surrounding tissues after a one-year followup. Br J Oral Maxillofac Surg 2001 
Oct;39(5):398-401.

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Screened
Enrolled 130 
(30 lost to 
F/U)
ORIF 60
Stryker 
Hybrid 
archbars
Erich 
archbars
CR 40
Stryker 
Hybrid 
archbars
Erich 
archbars

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Budget 
 
1) Research Coordinator 0.3 FTE 
 
 Prepare and submit IRB application 
 Follow subjects and ensure adequate F/U 
 Data entry 
 Record Data on site 
 Issue Reimbursement to subjects 
 
 
 
 
 
 
30% of 1 FTE ($46000) for 2 yrs 
 
 
 
 
 
plus fringe 26.5% 
 
 
$34,914 
 
 
2) Subject Reimbursement (100) 
 
 
 
 
$5000 
 
 
 
3) Redcap data base (electronic)  
 Setup 
 Annual fees 
 
 
 
 
 
 
 
 
 
 
$2500 
 
4) Data analysis and randomization  
 
 
 
$3000 
 
5) Salary Support  
 Gary Bouloux MD, DDS     
 
1% effort 
 
$5000 
 
     6) Indirect  
 
 
 
 
39%  
 
$19661 
 
TOTAL 
 
 
 
 
 
 
 
 
$70075