Ankle fractures are common musculoskeletal injuries, with one study showing an incidence of 187 ankle fractures per 100,000 person-years.1 They are the fourth most common type of fracture, accounting for approximately 7% of all fractures, with epidemiologic studies showing an increasing incidence.2–5
Ankle fractures place both a clinical and an economic burden on society. Belatti and Phisitkul6 conducted a study showing that the economic impact of foot and ankle surgery in the Medicare population alone was $11 billion annually, with operative treatment of bimalleolar and trimalleolar ankle fractures having the third greatest economic impact of all foot and ankle procedures.6
As the cost of health care continues to increase in the United States, clinicians must critically evaluate their own practices to help minimize unnecessary expenditures. Implant choice has become an increasingly important area of scrutiny in orthopedics, especially given the range of clinically appropriate options.
In unstable ankle fractures, surgery is indicated to reduce the development of posttraumatic arthritis.7 This typically involves open reduction and internal fixation of the distal fibula with an antiglide plate on the posterolateral surface of the fibula, or a laterally placed neutralization plate with an interfragmentary lag screw. Implant choices include one-third tubular plates and precontoured anatomic plates, with or without locking screws. Although anatomic plating may be beneficial in specific cases, no published data exist justifying its blanket use. There are substantial differences in the cost of various plate constructs. This study sought to compare the economic impact of one-third tubular plates, placed with nonlocking screws, vs periarticular distal fibular plates, placed with either locking or nonlocking screws, in the treatment of lateral malleolus fractures. The authors hypothesized that in AO/OTA type 44B and 44C fractures, the use of one-third tubular plate constructs would significantly minimize implant cost.
Materials and Methods
Once institutional review board approval had been obtained, a retrospective chart and radiographic review was performed of patients who had undergone open reduction and internal fixation of AO/OTA type 44B or 44C fibula fractures. Inclusion criteria were AO/OTA type 44B and 44C fibula fractures that were treated operatively with plate fixation, no history of ipsilateral ankle fracture, operative treatment within 2 weeks of initial evaluation, and age 18 to 55 years. Exclusion criteria were an unstable syndesmosis requiring stabilization, fibula fractures that were treated with an intramedullary device or tension band fixation, comminution preventing the ability to compress across the fracture site, age older than 55 years, and fractures distal to the syndesmosis (AO/OTA type 44A).
Between 2006 and 2013, a total of 201 patients were identified who met the inclusion criteria. All were treated at a single institution of a multicenter practice by 1 of 4 foot and ankle fellowship-trained orthopedic surgeons (S.M.R., J.A., D.I.P.). Office notes, radiographs, and operative reports were reviewed. Patient demographic data were collected, including age, sex, body mass index, presence of diabetes, and smoking status. Radiographs were used in conjunction with operative reports to determine the type of plate as well as the types and numbers of screws used in the construct to treat the fibula fracture. All patients were treated with interfragmentary lag screw fixation and lateral neutralization plating consisting of either a one-third tubular plate or an anatomic periarticular distal fibular plate. Facility-specific, plate-specific costs were obtained for each case. To develop a conservative economic model focused on actual differences in plate costs, screw costs were assumed to be constant between the 2 construct options.
The Nationwide Inpatient Sample, the largest publicly available all-payer database, developed for the Healthcare Cost and Utilization Project by the Agency for Healthcare Research and Quality,8 was queried for postoperative diagnoses of ankle fractures (International Classification of Diseases, Ninth Revision, codes 824.2 through 824.7) to estimate the incidence of ankle fractures requiring open reduction and internal fixation of the lateral malleolus.
Decision tree analysis has been increasingly used in orthopedics to compare treatment options, especially gaining acceptance for cost-benefit and economic analysis.9–14 Decision trees may be built using a variety of data sources, including population databases, retrospective reviews, and existing literature, and may be used to follow cohorts across time or to analyze cross-sectional cohorts.15,16 By stochastically analyzing models, variability can be captured, improving generalizability.9,17 A Monte Carlo simulation was conducted with the estimated at-risk US population to calculate the associated costs and economic burden of one-third tubular plates vs anatomic plates in open reduction and internal fixation of lateral malleolus fractures. Additionally, a 2-sample test was used to determine if there was a statistical difference between the total costs of the 2 types of constructs. P<.05 was considered statistically significant.
Decision tree analysis was conducted using TreeAge Pro 2015, R1.0 release, software (TreeAge Software, Inc, Williamstown, Massachusetts). All statistical analyses were performed using SPSS version 12.0 software (IBM, Chicago, Illinois).
A total of 201 patients who met inclusion criteria were treated for AO/OTA type 44B and 44C fractures. Of these, 120 patients were treated with one-third tubular plates and 81 were treated with various periarticular distal fibular plates. The one-third tubular plate group did not differ statistically from the periarticular distal fibular plate group for any patient demographic (Table). Using the Nationwide Inpatient Sample database, the authors estimated that the annual incidence of admitted operatively treated ankle fractures requiring fibula plating in the United States was 59,029. According to the authors' facility-specific costs, one-third tubular plating had an average per plate cost of $90.86 (95% confidence interval, $90.84-$90.87). Anatomic plating, on the other hand, had an average per plate cost of $746.97 (95% confidence interval, $746.55–$747.39). Across the United States, use of only one-third tubular plating would result in plate costs totaling $5,363,375 per year (95% confidence interval, $5,362,513–$5,364,237), whereas anatomic plating would result in plate costs totaling $44,092,892 per year (95% confidence interval, $44,068,163–$44,117,621)—a statistically significant difference of $38,729,517 per year (95% confidence interval, $38,704,773–$38,754,261; P<.0001).
In the current health care climate, the economics of operative management are being increasingly scrutinized. The burden of cost-effectiveness of implant choice falls on the surgeon when multiple, clinically appropriate options exist, and the direct economic burden on any cost differential falls on the hospital. Whenever possible, there should be clear evidence that the more costly option provides superior outcomes. Recently, the number of new implant designs specific to the distal fibula has grown. Although cadaveric studies have shown differences in the biomechanical strength of various constructs, it is unclear what benefit this translates to clinically. A biomechanical cadaveric study by Schaffer and Manoli18 examined lateral neutralizing plates vs antiglide plates for short oblique fractures. Antiglide plating was found to be stiffer and stronger and to require more energy to failure than lateral plating; however, the clinical significance of the difference could not be determined. Studies regarding the clinical outcomes of the 2 methods have found them comparable in terms of functional scores and complication rates.19
In the current study, all fractures were fixed with an interfragmentary lag screw and a lateral neutralizing plate. A recent study compared 4 different lateral neutralization plates in the treatment of simulated AO/OTA type 44B distal fibula fractures in cadaveric specimens. Plating was performed with a Synthes one-third tubular plate, a Synthes LCP plate with locked screws, the precontoured, non-locked TriMed Sidewinder, or an Ortho-helix MaxLock Extreme locked, precontoured plate. No significant differences in bending stiffness, torsional stiffness, or fracture site motion were found between the different plates.20
There are some cases (eg, patients with osteoporosis and poor bone stock) in which biomechanical studies show that periarticular anatomic locking constructs may confer benefit; however, results have been mixed, and clinical data are lacking.21–24 In a biomechanical cadaveric study by Davis et al,21 construct rigidity of one-third tubular plates was compared with that of periarticular distal fibular plates in osteoporotic bone. Increased rotational strength with periarticular plates was shown; however, these authors could not recommend against using one-third tubular plating for osteoporotic bone, explaining that fixation obtained was still adequate for treatment. In another biomechanical cadaveric study, Minihane et al23 showed that one-third tubular plates, when used in an antiglide fashion, provided more stability than lateral periarticular locking plates in osteoporotic distal fibula fractures.
A prior, unpublished study by the current authors found no difference between one-third tubular plates and precontoured anatomic plates in the ability to achieve and maintain reduction.
In the face of clinical equipoise, surgeons may tend to choose implants on the basis of their personal training, their familiarity with the instruments, and the ease of use of an implant. However, the current authors challenge surgeons to consider implant costs when choosing fixation constructs for all fractures. In the previous Distal Radius Acute Fracture Fixation Trial,25 percutaneous Kirschner wire fixation was compared with volar locking plates in the treatment of distal radius fractures. Major cost savings occurred with the use of percutaneous Kirschner wire fixation without detriment.
The current findings suggest that general use of one-third tubular plating instead of anatomic plating whenever possible for fibula fractures would result in cost savings of up to nearly $40 million annually in the United States. This margin will become more important to providers with shifts toward bundled payments, with studies showing the easiest cost-containing strategy to be the use of generic, low-cost, high-value orthopedic implants whenever appropriate.26
Limitations of this study included its retrospective nature, which may have introduced bias for treatment and patient selection. The authors tried to control for this by selecting cohorts that were similar in demographics and fracture classification. In this study, the cost difference between one-third tubular plates and anatomic distal fibular plates was based on the facility-specific costs across multiple centers staffed by surgeons in the same group. The exact costs may differ from one institution to another based on multiple factors, including practice size, location, and medical device company partnerships. However, the cost difference between one-third tubular plates and pre-contoured anatomic plates is substantial, even if the exact costs vary slightly based on practice settings. Another limitation of this study was its narrow focus on only the cost of the implants. Further examination of other costs possibly associated with implant choice, such as differences in operating room time, revision rates, hardware failure rates, and hardware removal rates, is warranted for a complete analysis of cost-effectiveness of implant choice. However, given that, in the current series, surgeon preference primarily drove implant choice, the authors think that the primary driver in cost was implant choice. Finally, unlike usual cost-effectiveness studies, this study did not provide a metric, such as quality-adjusted life years gained, for the effectiveness of implant choice. However, in a parallel, unpublished study, the current authors investigated the effectiveness of one-third tubular plates vs precontoured anatomic plates in achieving and maintaining anatomic reduction, finding no difference between the 2 types of plates.
Although the authors argue for the judicious use of expensive precontoured locking plates, they admit that there are some cases in which anatomic locking plates do play an important role in the treatment of distal fibula fractures. As previously mentioned, patients with poor bone stock and osteoporosis may benefit from locked plating. In addition, anatomic locking plates may be the best choice for comminuted distal fibula fractures and very distal fibula fractures.27
Unless clinically justifiable on a per-case basis, or until the advent of studies showing significant clinical benefit, there currently is no reason for the substantially increased expense from widespread use of precontoured anatomic fibular plating for fractures amenable to one-third tubular plating.
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- Shibuya N, Davis ML, Jupiter DC. Epidemiology of foot and ankle fractures in the United States: an analysis of the National Trauma Data Bank (2007 to 2011). J Foot Ankle Surg. 2014; 53(5):606–608. doi:10.1053/j.jfas.2014.03.011 [CrossRef]
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- Thur CK, Edgren G, Jansson KÅ, Wretenberg P. Epidemiology of adult ankle fractures in Sweden between 1987 and 2004: a population-based study of 91,410 Swedish inpatients. Acta Orthop. 2012; 83(3):276–281. doi:10.3109/17453674.2012.672091 [CrossRef]
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|Demographic||One-Third Tubular Plate Group||Precontoured Plate Group||P|
|Age, mean (range), y||34.95 (18–53)||34.27 (18–50)||.421|
|Body mass index, mean (range), kg/m2||29.67 (18.7–55.8)||27.99 (18.3–46.3)||.758|