Abstract
Importance
Erich arch bars, 4-point fixation, and bone-supported arch bars are currently used in maxillomandibular fixation, although to what extent they differ in terms of overall charges and clinical outcomes has yet to be reported.
Objective
To determine the association of Erich arch bars, 4-point fixation, and bone-supported arch bars in maxillomandibular fixation with hospital charges and clinical outcomes.
Design, Setting, and Participants
This historical cohort included 93 patients with mandible fracture who underwent maxillomandibular fixation from January 1, 2005, to June 30, 2015, at a tertiary care center. Statistical analysis was conducted from October 4, 2015, to September 8, 2017.
Main Outcomes and Measures
Charge analysis from an institutional perspective, operative time, necessity for a secondary procedure, and postoperative complications.
Results
Of the 93 patients in the study (18 women and 75 men; median age, 28.0 years [interquartile range, 23.0-40.0 years]), 27 (29%) received Erich arch bars, 51 (55%) received 4-point fixation, and 15 (16%) received bone-supported arch bars. The mean operative time for Erich arch bars (98.7 minutes; 95% CI, 89.2-108.2 minutes) was significantly longer than for 4-point fixation (48.8 minutes; 95% CI, 41.8-55.7 minutes) and bone-supported arch bars (55.9 minutes; 95% CI, 43.1-68.6 minutes). A total of 17 patients who received Erich arch bars (63%), 37 patients who received 4-point fixation (72%), and 1 patient who received bone-supported arch bars (7%) needed to return to the operating room for hardware removal. Patients who received Erich arch bars and those who received 4-point fixation had significantly higher odds of requiring a secondary procedure than did patients who received bone-supported arch bars (Erich arch bars: odds ratio, 27.1; 95% CI, 2.7-274.6; and 4-point fixation: odds ratio, 42.8; 95% CI, 4.4-420.7). Mean total operative charges for application of the hardware alone were significantly less for 4-point fixation ($5290; 95% CI, $4846-$5733) and bone-supported arch bars ($6751; 95% CI, $5936-$7566) than for Erich arch bars ($7919; 95% CI, $7311-$8527). When secondary procedure charges were included, the mean total charge for Erich arch bars ($9585; 95% CI, $8927-$10 243) remained significantly more expensive than the mean total for 4-point fixation ($7204; 95% CI, $6724-$7684) and bone-supported arch bars ($6924; 95% CI, $6042-$7807). No clinically meaningful difference in complications between groups was found (Erich arch bars, 3 [11%]; 4-point fixation, 5 [10%]; and bone-supported arch bars, 2 [13%]).
Conclusions and Relevance
Bone-supported arch bars have comparable complication outcomes, operative time for placement, and overall charges when compared with Erich arch bars and 4-point fixation, and have a lower likelihood of requiring removal in an operative setting.
This cohort study examines the association of Erich arch bars, 4-point fixation, and bone-supported arch bars in maxillomandibular fixation with hospital charges and clinical outcomes.
Key Points
Question
To what extent do Erich arch bars, 4-point fixation, and bone-supported arch bars for maxillomandibular fixation differ in overall hospital charges and clinical outcomes?
Finding
In this cohort study of 93 patients, Erich arch bars were significantly more expensive than 4-point fixation and bone-supported arch bars, while charges were comparable between 4-point fixation and bone-supported arch bars. No significant differences in rates of complication were seen between the groups.
Meaning
Bone-supported arch bars may be considered an attractive alternative to 4-point fixation and Erich arch bars given the evidence for comparable complication outcomes and overall charges in conjunction with a relatively short operative time and lower likelihood of requiring removal in an operative setting.
Introduction
Facial fractures continue to place a significant burden on the US health care system, with estimated annual costs of greater than $1 billion.1,2 Of the various locations in which facial fracture can occur, the mandible is the most commonly fractured facial bone requiring medical intervention, accounting for more than 64% of all facial fracture reductions performed in the United States annually.1,3,4,5
The main goal of mandibular fracture treatment is reduction of the fractured bone segments to reproduce the interrelationship of the occlusal surfaces. Surgical approaches for the treatment of mandibular fractures include open-reduction with rigid internal fixation (ORIF), maxillomandibular fixation (MMF), or a combination of the 2 procedures. Although surgical approaches are guided largely by fracture type, MMF is often regarded as the more traditional and conservative therapy, while ORIF is considered the more resource-intensive therapy. Several studies, including a randomized clinical trial, have shown MMF treatment to have significant cost and quality of life advantages compared with ORIF treatment without changing overall clinical outcomes.6,7,8 However, given that otolaryngology, plastic surgery, and oral and maxillofacial surgery all provide surgical management for patients with mandibular injuries, the optimal surgical technique remains at the discretion of the treating surgeon, and is dependent largely on the patient’s general condition, bone quality, fracture characteristics, and available evidence at the time of treatment.
A variety of techniques are currently used when performing MMF (Figure). The traditional MMF procedure uses Erich arch bars with interdental wiring, and its ability for maintaining excellent reproducibility of occlusion is well established within the literature.9,10,11 Although arch bars are relatively inexpensive, their drawbacks include prolonged operating time for placement, high risk of wire stick injuries during placement, significant pain and discomfort to the patient, periodontal trauma, and compromising oral hygiene with increased risk of caries.12,13,14,15 These same wires are often difficult to remove in the clinic because of patient discomfort. An alternative technique pioneered in the early 1990s called 4-point fixation uses 4 specialized self-drilling, self-tapping intermaxillary fixation bone screws placed in the maxillar and mandibular positions according to the fracture location, dentition, extent of surgical exposure, and quality of bone.12 Steel wiring is secured in a looped fashion over the screw shoulder on each opposing jaw to achieve MMF. Advantages of intermaxillary fixation screws include shortened operating time, minimization of hardware within the oral cavity, improved oral hygiene, and better patient tolerability; however, intermaxillary fixation screws also come with an increased hardware cost, risk of tooth root injury during placement, and risk of loss of fixation with screw avulsion.11,12,16,17,18,19 Furthermore, occlusal outcomes with 4-point fixation can be strongly dependent on screw location: the relatively anterior location of the screws and wires when in occlusion inherently provides a biomechanical disadvantage posteriorly.17,20,21
Figure. The 3 Different Techniques Currently Used in Maxillomandibular Fixation.
From left to right: Erich arch bars, bone-supported arch bars, and 4-point fixation.
In 2012, Stryker launched a bone-supported arch bar system (SmartLock Hybrid MMF, Stryker Corp), which was shortly followed by the Synthes MatrixWAVE MMF System in 2014 (DePuy Synthes Co) and the Biomet Microfixation OmniMax MMF System in 2015 (Biomet Inc). These new bone-supported arch bar systems are proposed to provide the occlusive stability of Erich arch bars with the tolerability of 4-point fixation. As such, there is growing interest in determining to what extent the use of Erich arch bars, 4-point fixation, and bone-supported arch bar fixation systems differ in terms of overall charges to the patient or patient’s insurance carrier and clinical outcomes.
In this study we review a cohort of patients with radiographically confirmed, isolated mandibular fractures treated with Erich arch bars, 4-point fixation, or bone-supported arch bar fixation to determine the association between the different MMF treatment methods currently in use and the charges for care, operative times, and rates of complications.
Methods
We analyzed the records of patients treated with MMF at Wake Forest Baptist Medical Center between January 1, 2005, and June 30, 2015. Surgery within the study was performed by facial plastic surgeons, otolaryngologists, and plastic surgeons. Inclusion criteria for patients included age 15 years or older, radiographically confirmed mandible fracture at presentation, and that the patient underwent MMF treatment with Erich arch bars, 4-point fixation, or bone-supported arch bars with a minimum follow-up length of 4 weeks. Excluded from the study were cases involving mandible fractures secondary to gunshot wounds, cases in which ORIF was also performed, concurrent midface fractures, fractures secondary to severe facial trauma requiring multiple surgical procedures, or those with inadequate follow-up. This study was approved by the Wake Forest Baptist Health Institutional Review Board, which waived patient consent as all patient data were deidentified.
Patient age, sex, smoking status, fracture location, and postoperative complications were recorded. Operative time for hardware placement and hardware removal (if necessary) were also recorded. Operating time, defined as the time interval recorded by the nursing staff between procedure start and finish times, was used to determine facility and anesthesia charges at our home institution. Surgeon fees were excluded given the invariability of this charge across the 3 different interventions. All charges were calculated and reported in US$.
Based on national averages in 2017 when the data were collected, Erich arch bar hardware was estimated to be $40, a single Karlis screw used in 4-point fixation was estimated to be $105, a single arch bar used in bone-supported arch bar fixation was estimated to be $285, and a single locking screw used in bone-supported arch bar fixation was estimated to be $120. The charge for anesthesia at our home institution is $469 per unit, in which 5 base units are charged per procedure and 1 unit is charged every 15 minutes until completion of the procedure. The operating room (OR) facility charge at our institution progressively increases per every 30 minutes, and ranges from $296 at 0 to 30 minutes to $1923 at 210 to 240 minutes. The total charges to the patient or patient’s insurance carrier for each MMF technique was calculated by combining the hardware charge with the anesthesia and facility charges for placement. A separate charge analysis was conducted that included the additional charges incurred for return to the OR for removal of hardware. Given that the time associated with removal is negligible (<30 minutes) without significant disposable hardware charges for all 3 techniques, a flat charge of $2640 ($2344 for anesthesia according to 5 base units and $296 for the facility) was assigned per operative removal procedure.
Rates of malocclusion, malunion, nonunion, wound dehiscence, tooth damage, injury to tooth roots, infection, plate fracture, screw fracture, screw loosening, and loss of screw at follow-up were compared. If apparent tooth devitalization was present, tooth root injury was assessed by follow-up orthopantomography.
Statistical Analysis
Statistical analysis was conducted from October 4, 2015, to September 8, 2017. Outcomes were defined from the date of surgery to the date of last follow-up. Descriptive statistics for patient characteristics were calculated as means and SDs or percentages as appropriate. For the 3 dichotomous outcomes of any complication, malocclusion, and return to the OR, a multivariable logistic model was used to assess the effect of MMF application type on the outcome after controlling for age, sex, smoking status, and fracture location. Odds ratios and 95% CIs were calculated using these models. For the continuous outcomes of OR time and total operative charges with and without return to OR charges, a multivariable linear regression model was used to assess the association of MMF application type with the outcome after controlling for age, sex, smoking status, and fracture location. Least squares mean values and 95% CIs were calculated using these models. All P values were from 2-sided tests and results were deemed statistically significant at P < .05.
Results
Patient Characteristics
From an initial sample of 185 patients treated with MMF at our institution, 93 patients were identified who had undergone treatment with 1 of the 3 techniques of interest and fulfilled our inclusion criteria. A total of 82 patients were excluded for receiving concomitant ORIF and an additional 10 patients did not meet the minimum 4-week follow up. A total of 27 patients (29%) underwent fixation with Erich arch bars, 51 patients (55%) underwent 4-point fixation, and 15 patients (16%) underwent fixation with bone-supported arch bars. Patient characteristics for the entire cohort as stratified by fixation technique can be found in Table 1. The median age at surgery was 28.0 years (interquartile range, 23.0-40.0 years), and patients were predominately male (75 [81%]). Cigarette, cigar, or smokeless tobacco use was common at the time of surgery (65 patients [70%]). Fractures mainly occurred at the subcondyle (28 [30%]), followed by the angle (24 [26%]) and body (13 [14.0%]), and fractures were bilateral in 11 patients (12%). The median follow-up duration was 42.0 days (interquartile range, 32.0-62.0 days) for Erich arch bars, 45.5 days (interquartile range, 38.0-61.0 days) for 4-point fixation, and 58.0 days (interquartile range, 45.0-75.0 days) for bone-supported arch bars.
Table 1. Characteristics for the Entire Cohort and Stratified by Maxillomandibular Fixation Technique.
| Characteristic | Patients, No. (%) | |||
|---|---|---|---|---|
| Overall (N = 93) | Erich Arch Bars (n = 27) | 4-Point Fixation (n = 51) | Bone-Supported Arch Bars (n = 15) | |
| Age, median (IQR), y | 28.0 (23.0-40.0) | 27.0 (21.0-39.0) | 31.0 (24.0-43.0) | 24.0 (23.0-40.0) |
| Sex | ||||
| Male | 75 (81) | 21 (78) | 42 (82) | 12 (80) |
| Female | 18 (19) | 6 (22) | 9 (18) | 3 (20) |
| Tobacco use | 65 (70) | 20 (74) | 34 (67) | 11 (73) |
| Fracture location | ||||
| Symphysis or parasymphyseal | 10 (11) | 3 (11) | 2 (4) | 5 (33) |
| Body | 13 (14) | 3 (11) | 8 (16) | 2 (13) |
| Angle | 24 (26) | 6 (22) | 16 (31) | 2 (13) |
| Ramus | 5 (5) | 1 (4) | 3 (6) | 1 (7) |
| Subcondylar | 28 (30) | 10 (37) | 15 (29) | 3 (20) |
| Condylar | 12 (13) | 3 (11) | 7 (14) | 2 (13) |
| Coronoid | 0 | 0 | 0 | 0 |
| Alveolar | 1 (1) | 1 (4) | 0 | 0 |
| Bilateral fractures | 11 (12) | 5 (19) | 5 (10) | 1 (7) |
Abbreviation: IQR, interquartile range.
Operative Time
The mean operative time was adjusted for age, sex, smoking status, and fracture location. The mean operative time for placement of Erich arch bars was 98.7 minutes (95% CI, 89.2-108.2 minutes), compared with 48.8 minutes (95% CI, 41.8-55.7 minutes) for 4-point fixation and 55.9 minutes (95% CI, 43.1-68.6 minutes) for bone-supported arch bar fixation (Table 2). Operative time was increased for Erich arch bars when compared with both 4-point fixation (–49.9 minutes; 95% CI, –38.2 to –61.6 minutes) and bone-supported arch bars (–42.8 minutes; 95% CI, –26.9 to –58.7 minutes). There was a slight difference in operating times for placement of 4-point fixation compared with bone-supported arch bars, as the mean application time for 4-point fixation was 7.1 minutes (95% CI, –7.4 to 21.6 minutes) less than the application of bone-supported arch bars.
Table 2. Comparison of Mean Operative Times for Hardware Placement by Maxillomandibular Fixation Technique.
| Operative Time | Erich Arch Bars (n = 27) | 4-Point Fixation (n = 51) | Bone-Supported Arch Bars (n = 15) |
|---|---|---|---|
| Mean (SD), min | 98.6 (29.6) | 48.8 (23.9) | 56.1 (15.4) |
| Least squares mean value (95% CI), min | 98.7 (89.2-108.2) | 48.8 (41.8-55.7) | 55.9 (43.1-68.6) |
Return to OR for Hardware Removal
There was a substantial difference among the 3 groups in the number of patients who required a secondary procedure for hardware removal. The number of patients who needed to return to the OR for hardware removal was relatively similar between those who received Erich arch bars (17 [63%]) and 4-point fixation (37 [72%]), while 1 patient who received bone-supported arch bars (7%) needed to return to the OR for hardware removal. Patients who received Erich arch bars and those who received 4-point fixation had significantly higher odds of requiring a secondary procedure than did patients who received bone-supported arch bars (Erich arch bars: odds ratio, 27.1; 95% CI, 2.7-274.6; and 4-point fixation: odds ratio, 42.8; 95% CI, 4.4-420.7).
Operative Charges
The mean total operative charges for application of the hardware alone for both 4-point fixation ($5290; 95% CI, $4846-$5733) and bone-supported arch bar fixation ($6751; 95% CI, $5936-$7566) was significantly less when compared with fixation with Erich arch bars ($7919; 95% CI, $7311-$8527), with overall differences of $2629 (95% CI, $2245-$3013) less for 4-point fixation and $1168 (95% CI, $649-$1687) less for bone-supported arch bar fixation when compared with Erich arch bars (Table 3). Charges for placement of 4-point fixation were also significantly less than bone-supported arch bar fixation, with a mean difference of $1461 (95% CI, $988-$1934). When the additional charges associated with a secondary procedure for hardware removal were included in the total mean operative charge analysis, Erich arch bars ($9585; 95% CI, $8927-$10 243) still remained clinically more expensive than both 4-point fixation ($7204; 95% CI, $6724-$7684; mean charge difference, $2381; 95% CI: $1965-$2797) and bone-supported arch bars ($6924; 95% CI, $6042-$7807; mean charge difference, $2661; 95% CI, $2099-$3223).
Table 3. Comparison of Overall Charges by Maxillomandibular Fixation Technique.
| Charge | Erich Arch Bars (n = 27) | 4-Point Fixation (n = 51) | Bone-Supported Arch Bars (n = 15) |
|---|---|---|---|
| Hardware charge, $ | 40 | 105 per screw | 285 per arch bar and 120 per screw |
| Mean charge, $ | |||
| Anesthesia | 5428 | 3869 | 4098 |
| Facility | 2483 | 975 | 1107 |
| Overall charge (95% CI), $ | |||
| Without operating room charge for removal of hardware | 7919 (7311-8527) | 5290 (4846-5733) | 6751 (5936-7566) |
| With operating room charge for removal of hardware | 9585 (8927-10243) | 7204 (6724-7684) | 6924 (6042-7807) |
Complications
A total of 10 patients experienced complications: 3 (11%) among those with Erich arch bars, 5 (10%) with 4-point fixation, and 2 (13%) with bone-supported arch bars (Table 4). Bite deformities occurred in 3 patients (11%) in the Erich arch bar group, 5 patients (10%) in the 4-point fixation group, and 2 patients (13%) in the bone-supported arch bar group. Different forms of malocclusion that occurred included class II and class III malocclusion, open bite, crossbite, and nonunion. In the Erich arch bar group, 1 patient (4%) experienced wound dehiscence and 1 patient (4%) experienced new tooth damage noted at hardware removal. In regard to screw-specific outcomes, 1 patient in both the 4-point fixation group (2%) and the bone-supported arch bar group (7%) experienced screw loosening prematurely, and 1 patient in the 4-point fixation group (2%) had premature loss of screw at follow-up. No patient experienced tooth root injury, infection, screw fracture, or plate fracture.
Table 4. Postoperative Complications for the Entire Cohort and Stratified by Maxillomandibular Fixation Technique.
| Complication | Patients, No. (%) | |||
|---|---|---|---|---|
| Overall (N = 93) | Erich Arch Bars (n = 27) | 4-Point Fixation (n = 5 1) | Bone-Supported Arch Bars (n = 15) | |
| Total No. of patients with complications | 10 (11) | 3 (11) | 5 (10) | 2 (13) |
| Malocclusion | 10 (11) | 3 (11) | 5 (10) | 2 (13) |
| Malunion | 0 | 0 | 0 | 0 |
| Nonunion | 1 (1) | 0 | 1 (2) | 0 |
| Wound dehiscence | 1 (1) | 1 (4) | 0 | 0 |
| Infection | 0 | 0 | 0 | 0 |
| Tooth damage | 1 (1) | 1 (4) | 0 | 0 |
| Tooth root injury | 0 | 0 | 0 | 0 |
| Plate fracture | 0 | 0 | 0 | 0 |
| Screw fracture | 0 | 0 | 0 | 0 |
| Screw loosening | 2 (2) | 0 | 1 (2) | 1 (7) |
| Loss of screw | 1 (1) | 0 | 1 (2) | 0 |
Discussion
In this study, we examined 93 patients with mandibular fracture treated at a tertiary care center with MMF using 1 of 3 techniques to determine if differences exist between them in health care delivery charges and clinical outcomes. This study is the first published series to our knowledge directly evaluating fixation with Erich arch bars vs 4-point fixation and bone-supported arch bar fixation for the treatment of mandibular fractures. We have shown that the self-drilling bone screws used in 4-point fixation and bone-supported arch bar techniques are associated with a reduction in operative time necessary for application when compared with Erich arch bars. The mean time for Erich arch bar placement at our institution coincides with operative times reported in previous studies,11,19,22,23 but some conflicting studies have noted much shorter times for application.24,25 These discrepancies in the literature may be owing in part to the variability in surgeon experience and technique between specialties, as well as possible alternative definitions of procedure start and end points.
Although the main goal of mandibular fracture treatment is reduction of the fractured bone segments to reproduce the interrelationship of the occlusal surfaces, the optimal treatment strategy is controversial. The use of MMF for the treatment of both nondisplaced and moderately displaced mandibular fractures has been proposed to have significant cost and quality of life advantages compared with ORIF treatment without changing clinical outcomes.6,7,8 However, the question still remains as to which MMF technique might be best for both limiting overall charges to the patient or patient’s insurance carrier and postoperative complications.
The historical use of Erich arch bars to achieve MMF has been challenged relatively recently by newer alternative MMF methods that rely on bone screws, including 4-point fixation in the early 1990s and bone-supported arch bar fixation in 2013. Comparative studies on application time, complications, and patient outcomes between Erich arch bars and 4-point fixation are already well documented in the literature.11,12,16,17,22 Studies involving bone-supported arch bar systems remain limited given its relatively recent approval by the US Food and Drug Administration.23,26
Although the hardware charges for 4-point fixation and, even more so, for bone-supported arch bars are substantially higher than the hardware charges for Erich arch bars, the overall charges per procedure at our institution was significantly lower for both 4-point fixation and bone-supported arch bars owing to the discrepancy in operative time between the techniques. The comparative similarity in ease of application exhibited by 4-point fixation and bone-supported arch bar systems did not parallel the ability to remove them in a nonoperative setting. Bone-supported arch bars were the only hardware system associated with a significant decrease in the likelihood of requiring removal within an operative setting when compared with the Erich arch bar and 4-point fixation systems. Although the decision to return to an operative setting for removal is ultimately dependent on surgeon preference, patient tolerance also can prevent hardware removal within nonoperative settings. When the added charges of a secondary procedure were taken into consideration, the increased overall charges associated with Erich arch bars became even more substantial, while no overall difference in charges associated with 4-point fixation and bone-supported arch bars was observed.
Furthermore, Erich arch bars and 4-point fixation have both reported advantages and disadvantages. Erich arch bars inherently risk traumatizing the periodontia given the circumferential placement of wire between teeth, while 4-point fixation is often perceived to be more prone to loss of fixation and malocclusion, given the often subperpendicular orientation of its screws to the occlusal plane coupled with an inability to exert a tension band effect.11,17,20,21 Because these complications are related to the inherent design of each system, the combination of features seen with the bone-supported arch bar systems is thought to potentially yield the advantages of both. Even so, we found no significant difference in overall complications between the 3 different techniques.
Charges were based on an institutional perspective of resources used, and as such indirect charges or out-of-pocket direct charges incurred by the patient were excluded. The out-of-pocket charges or insurance-billed charges to patients and/or a patient’s insurance were not used as the primary end point owing to the wide variability in monetary charges after hospital-patient or hospital-insurance negotiations.
Last, owing to the retrospective nature of this study, we were unable to consider patient morbidity factors in outcome measures. A formal cost-utility analysis that is able to incorporate quality-adjusted life-year measures in the setting of a prospective multi-institutional study may help better define the total economic cost implications associated with the 3 techniques evaluated in this study. Likewise, the inherent difficulty in obtaining long-term follow-up in trauma patient populations limits the results of our study to relatively short-term complications, and such a study could help clarify additional costs and complications that might occur on a more long-term basis.
Limitations
Our results should be interpreted with caution given the retrospective nature of the study, small sample size, and relatively short-term follow-up. Other limitations include those related to an academic hospital setting, including the high number of attending physicians in both otolaryngology and plastic surgery who performed the operations during the 10 years of the study, and subsequent inability to control for any variation in technique between surgeons.
Conclusions
We have shown that the use of the relatively new bone-supported arch bar systems are an attractive alternative to both 4-point fixation and Erich arch bars for obtaining MMF in patients with mandibular fracture given the evidence for comparable complication outcomes and overall charges to the patient or patient’s insurance carrier in conjunction with a reduction in operative time required for application and lower likelihood of requiring removal in an operative setting.
References
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