Operative Cost Comparison: Plating Versus Intramedullary Fixation for Clavicle Fractures

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1 Operative Cost Comparison: Plating Versus Intramedullary Fixation for Clavicle Fractures Andrew E. Hanselman, MD; Timothy R. Murphy, MD; George K. Bal, MD, FACS; E. Barry McDonough, MD abstract Although clavicle fractures often heal well with nonoperative management, current literature has shown improved outcomes with operative intervention for specific fracture patterns in specific patient types. The 2 most common methods of midshaft clavicle fracture fixation are intramedullary and plate devices. Through retrospective analysis, this study performed a direct cost comparison of these 2 types of fixation at a single institution over a 5-year period. Outcome measures included operative costs for initial surgery and any hardware removal surgeries. This study reviewed 154 patients (157 fractures), and of these, 99 had intramedullary fixation and 58 had plate fixation. A total of 80% (79 of 99) of intramedullary devices and 3% (2 of 58) of plates were removed. Average cost for initial intramedullary placement was $2955 (US dollars) less than that for initial plate placement (P<.001); average cost for removal was $1874 less than that for plate removal surgery (P=.2). Average total cost for all intramedullary surgeries was $1392 less than the average cost for all plating surgeries (P<.001). Average cost for all intramedullary surgeries requiring plate placement and removal was $653 less than the average cost for all plating surgeries that involved only placement (P=.04). Intramedullary fixation of clavicle fractures resulted in a statistically significant cost reduction compared with plate fixation, despite the incidence of more frequent removal surgeries. [Orthopedics. 2016; 39(5):e877-e882.] Clavicle fractures account for approximately 2.6% to 5% of all adult fractures. 1,2 Incidence rates peak in boys and men in the first 2 decades of life, with a second prominent cohort seen in elderly women. 3 Early studies in the 1960s by Neer 4 and Rowe 5 showed remarkably low nonunion rates for these types of fractures that were amenable to conservative management. In the past 20 years, however, numerous studies have contradicted these findings and reported higher nonunion rates than previously indicated. 6 This information created a shift toward operative intervention in appropriate fracture types, mainly displaced midshaft fractures, and this shift has resulted in improved nonunion rates and increased patient satisfaction. 7,8 Several studies have examined the different implant options available for clavicle fixation. These implants can be broadly categorized into 2 main groups, plate-and-screw constructs and intramedullary devices. Most current plating options incorporate dynamic compression and locking technology, with a preference for precontoured implants because The authors are from the Department of Orthopaedics, West Virginia University, Morgantown, West Virginia. Drs Hanselman, Murphy, and McDonough have no relevant financial relationships to disclose. Dr Bal is a paid consultant for and is on the speakers bureau of DePuy. Correspondence should be addressed to: Andrew E. Hanselman, MD, Department of Orthopaedics, West Virginia University, PO Box 9196, Morgantown, WV (ahansel1@hsc.wvu.edu). Received: October 16, 2015; Accepted: April 11, doi: / SEPTEMBER/OCTOBER 2016 Volume 39 Number 5 e877

2 of the unique shape of the clavicle. Reconstruction plates have been used for their contouring ability; however, they have been associated with nonunion. 9,10 Intramedullary options consist of Hagie pins, Herbert screws, Knowles pins, Steinmann pins, and titanium elastic nails, among others. 2 Both types of implants have advantages and disadvantages; however, studies comparing these 2 methods have yet to establish which type is optimal for fixation Because both types of implants are currently used by orthopedic surgeons, this study evaluated the costs associated with each type of fixation. The goal of the study was to directly compare the operative costs associated with clavicle open reduction and internal fixation (ORIF), particularly with regard to plating and intramedullary implants. The study hypothesis was that intramedullary fixation, despite the more frequent need for a second surgery for implant removal, would result in decreased operative costs compared with plate fixation. To the authors knowledge, no studies have compared the costs of these 2 methods of clavicle fixation. Materials and Methods Selection of Participants After the study was approved by the institutional review board, a retrospective chart review was completed with electronic medical records. Current Procedural Terminology (CPT) code (open treatment of clavicle fracture) was used to identify all patients who underwent clavicle fracture fixation performed by 2 board-certified orthopedic surgeons (G.K.B., E.B.M.) with specialization in shoulder surgery at the study institution between approximately 2008 and Inclusion criteria were midshaft clavicle fractures, intramedullary and plate fixation, and access to adequate billing information. Exclusion criteria were clavicle fractures that involved other procedures during the same operative case (ie, scapula repair, acromioclavicular joint repair), inadequate billing information, and hardware removal performed in the outpatient clinic. There were no exclusions based on age, sex, or race. Data Collection Records that were eligible for the study were reviewed by the primary investigators (A.E.H., T.R.M.) and categorized as either plate fixation or intramedullary fixation. Patient billing records were analyzed for the operative costs associated with any procedures involving hardware placement and hardware removal. These costs included supplies (general, sterile, nonsterile, and implants), operating room services, anesthesia services, and recovery room fees. Excluded costs included pharmacy services, laboratory services, inpatient fees, emergency department fees, and physical or occupational therapy. These costs were excluded because of their variability and dependence on many confounding factors. Statistical Methods Descriptive statistical analysis was used to evaluate the data. Student s t test was performed to compare the operative costs of intramedullary and plate fixation. The significance level (alpha) was set at Results Demographics The initial CPT code search identified 188 patients (193 clavicle fractures) who were treated between April 2008 and January On further review, 34 patients (36 fractures) were excluded because of lack of billing data, inadequate billing data, or subsequent intraoperative procedures that did not allow for differentiation of costs. Two of these 34 patients were excluded because they underwent hardware removal in the outpatient clinic. These adjustments resulted in a final study cohort of 154 patients (157 fractures). Average age was 32 years (range, years), with 120 male and 34 female patients. Fracture Treatment Type A total of 63% (99 of 157) of the fractures were treated with intramedullary fixation, and 37% (58 of 157) were treated with plate fixation. In addition, 80% (79 of 99) of the intramedullary implants and 3% (2 of 58) of the plate implants were removed intraoperatively. Average time to intramedullary implant removal from the original surgery date was 112 days. Of the 2 plate implants, 1 was removed at 161 days and the other was removed at 480 days. Fracture Description All fractures included in the study were considered midshaft clavicle fractures (located in the middle third), based on plain film evaluation by the senior authors (G.K.B., E.B.M.). In the plate group, 29% (17 of 58) were simple fractures and 71% (41 of 58) were comminuted. In the intramedullary group, 57% (56 of 99) were simple fractures and 43% (43 of 99) were comminuted. Implant Type In the plate group, 3 different implants were used. Of these patients, 82% (47 of 57) were treated with an Acumed Clavicle Plate (Acumed, Hillsboro, Oregon). In addition, 16% (9 of 57) were treated with a Synthes Reconstruction Plate (Synthes, Inc, West Chester, Pennsylvania). The remaining 2% (1 of 57) were treated with an Arthrex Clavicle Plate (Arthrex, Inc, Naples, Florida). Locking screws were used in 28% (16 of 57) of the plate surgeries. In the intramedullary group, 2 different implants were used. Of these patients, 52% (51 of 99) were treated with a Rockwood Clavicle Pin (DePuy Orthopaedics, Inc, Warsaw, Indiana) and 48% (48 of 99) were treated with a Hagie Clavicle Pin (Smith & Nephew, Inc, Memphis, Tennessee). e878 Copyright SLACK Incorporated

3 Operative Time Average operative time was similar for both treatment types. The plate group had an average operative time of 2 hours and 4 minutes. The intramedullary group had an average operative time of 2 hours and 5 minutes. Time calculations were based on total operative time, including placement and removal surgeries. Operative time was defined as the period from patient entrance into the operating room until patient exit from the operating room. Itemized Operative Costs Table 1 shows the results of the itemized cost analysis. For operating room supplies, which included general supplies, nonsterile supplies, sterile supplies, and the operative implant, there was an average difference of $1031, with the intramedullary device costing less (P<.001). For operating room services, the average difference was $478, with the intramedullary device costing less (P=.030). For anesthesia services, the average difference was $10, with the intramedullary device costing less (P=.149). For recovery room services, the average difference was $128, with plate fixation costing less (P=.013). Total Operative Cost Table 2 shows the results of the total cost analysis. Intramedullary placement (n=99) had an average cost of $9949 (range, $4794-$15,805), whereas plate placement (n=58) had an average cost of $12,904 (range, $8057-$16,718). The difference was $2955, with average intramedullary placement costing less than plate placement (P<.001). Intramedullary removal (n=79) had an average cost of $2131 (range, $891-$5082), whereas plate removal (n=2) had an average cost of $4005 (range, $2536-$5473). This difference was $1874, with average intramedullary removal costing less than plate removal (P=.2). Average total cost for all fractures fixed, regardless of whether the implants were removed, resulted in average total cost for intramedullary fixation (n=99) of $11,650 (range, $6179- $18,951) and average total cost for plate fixation (n=58) of $13,042 (range, $8057- $19,038). This difference was $1392, with average total cost for intramedullary fixation less than that for plate fixation (P<.001). Average total cost for all fractures treated with intramedullary placement and removal (n=79) was $12,232 (range, $6179-$18,951), whereas the average total cost for fractures treated only with plate placement (n=56) was $12,885 (range, $8057-$16,718). The difference was $653, and the average total cost for intramedullary placement and removal was less than the average total cost for plate placement alone (P=.04). Complications No documented cases of nonunion occurred in the plate group (0%). There were 4 documented cases of nonunion Table 1 Average Itemized Costs of Clavicle Fixation a Cost Intramedullary Plate Discussion The findings of this study supported the initial hypothesis that intramedullary fixation of clavicle fractures results in lower operative costs compared with plate fixation. These results were statistically significant when the average initial costs for surgical placement and the average total surgical costs for all clavicles treated at the study institution were compared. Because most intramedullary im- Intramedullary- Plate Difference Operating room supplies -$1031 <.001 Average $4714 $5746 Median $4495 $5757 Range $1903-$8672 $1072-$10,119 Operating room services -$ Average $5852 $6330 Median $5787 $6017 Range $2664-$9206 $3573-$10,376 Anesthesia services -$ Average $233 $244 Median $235 $236 Range $104-$389 $151-$395 Recovery room services $ Average $849 $720 Median $803 $677 Range $319-$2224 $151-$1921 a Values rounded to the nearest whole US dollar. in the intramedullary group (4%). In the plate group, 6 patients had supraclavicular nerve paresthesias (11%), 5 patients had painful or prominent hardware (9%), and 2 patients had prolonged postoperative drainage (4%) that was treated successfully with oral antibiotics. In the intramedullary group, 37 patients had painful or prominent hardware (37%) and only 1 patient had prolonged postoperative drainage (1%) that was treated successfully with oral antibiotics. P SEPTEMBER/OCTOBER 2016 Volume 39 Number 5 e879

4 Table 2 Average Costs of Clavicle Fixation a Cost Intramedullary Plate Intramedullary- Plate Difference Placement only -$2955 <.001 Average $9949 $12,904 Median $9921 $13,122 Range $4794-$15,805 $8057-$16,718 Removal only -$ Average $2131 $4005 Median $2125 $4004 Range $890-$5082 $2536-$5473 Total (all fractures) -$1392 <.001 Average $11,650 $13,042 Median $11,692 $13,122 Range $6179-$18,951 $8057-$19,038 Total (intramedullary placement/removal vs plate placement only) Average $12,232 $12,885 Median $12,098 $13,081 Range $6179-$18,951 $8056-$16,718 a Values rounded to the nearest whole US dollar. plants placed at the authors institution are removed and most plating implants are not, this study also compared both of these average costs. This comparison showed statistically significant cost savings in the intramedullary group, despite the need for 2 surgical procedures vs 1 procedure. Although the subset of patients undergoing surgery for clavicle fractures is substantially smaller than that of patients treated without surgery, operative management of clavicle fractures has increased significantly over the past 2 decades. Traditionally, these fractures were believed to have remarkably low nonunion rates with nonoperative management. In the 1960s, separate studies by Neer 4 and Rowe 5 reported nonunion rates of less than 5% with conservative management. However, more recent studies showed higher nonunion rates than previously reported as well as a benefit from operative fixation in appropriate fracture types. 16,17 A randomized controlled study of ORIF vs nonoperative management for displaced midshaft clavicle fractures by the Canadian Orthopaedic Trauma Society 7 showed earlier radiographic union, a lower rate of nonunion, improved patient satisfaction, and improved function at 1 year in the operative group. A randomized controlled study by Robinson et al 6 reported similar findings, with ORIF for displaced midshaft clavicle fractures resulting in a lower nonunion rate vs nonoperative treatment. A recent meta-analysis by McKee et al 8 confirmed lower rates of nonunion and symptomatic malunion in addition to earlier return to function in operative groups. Although most clavicle fractures have satisfactory healing with nonoperative management, some types of fractures benefit from operative intervention. Many implants are available for clavicle fixation. These devices are often P -$ grouped into 2 broad categories: plateand-screw constructs and intramedullary implants. Although most surgeons prefer plating, especially for midshaft clavicle fractures, there are advantages and disadvantages to both types. On 1 hand, plates tend to provide more rigid stabilization, especially with the advent of locking-plate technology, and in cases of severe comminution, plates may allow earlier rehabilitation. 18 Disadvantages include larger surgical exposure and more extensive soft tissue disruption, the potential risk of vascular injury with screw placement, more difficult hardware removal, and increased fracture risk after hardware removal. 2 On the other hand, intramedullary devices offer better preservation of soft tissue, improved cosmesis, easier implant removal, and lower risk of refracture after implant removal. Disadvantages include the unfamiliarity of most surgeons with the procedure, pin migration, potential shortening and rotation of the fracture, and increased need for hardware removal. 19 Numerous studies have compared these 2 methods of fixation. Wenninger et al 11 compared intramedullary pinning and plating for acute midshaft fractures in an active military population. Results showed similar union rates and return to full duty in both groups, along with increased complication risk in the plating group. Kleweno et al 13 reported similar results in a comparison of intramedullary pinning and plating in acute midshaft clavicle fractures in the general population. Several meta-analyses and systematic reviews have been performed within the past few years. Duan et al 12 looked at randomized controlled trials comparing plate fixation, intramedullary fixation, and nonoperative management and found no difference between plate and intramedullary fixation in shoulder scores and rates of nonunion and infection. However, they reported increased side effects of implantation with plating, which they defined as symptomatic hardware events. e880 Copyright SLACK Incorporated

5 In a systematic review, Houwert et al 14 examined several lower-level studies and concluded that limited data supported 1 method of treatment over the other. Overall, data seem to be inconclusive regarding which implant type provides superior outcomes with clavicle fractures. Cost-effectiveness is an important consideration in the current health care environment, specifically with health care policy and reimbursement a constant topic of debate. The authors performed a thorough literature search and found no studies that evaluated and compared the cost of plate and intramedullary fixation. However, 2 studies analyzed the cost of operative clavicle fixation compared with conservative management. Pearson et al 20 performed a formal cost-effectiveness analysis based on prospective randomized controlled data on 132 patients with a displaced midshaft clavicle fracture. They reported a cost-effectiveness ratio of $65,000/quality adjusted lifeyear, which was within the range of many widely used procedures. These data represented the societal impact of clavicle fracture fixation; however, the study did not analyze information on individual patient costs. A more recent study by Althausen et al 21 examined individual patient data in a comparison of operative vs nonoperative management. They reviewed 204 patients with displaced midshaft clavicle fractures and showed that the operative group had an average cost savings of $5091 compared with the nonoperative group. Although initial hospital bills were higher as a result of surgical intervention, the operative group lost less time from work and therefore lost less income. Both studies are important for evaluating the cost-effectiveness of clavicle fracture fixation, but they do not provide a comparison of different treatment methods. Although the current study provided statistically significant results, there are several limitations to consider. First, the study was retrospective in design; therefore, the data set was limited to previously recorded information and patient records. Of the original 193 fractures analyzed, 36 were excluded because of absent cost reporting, inadequate cost reporting, or inability to differentiate costs from other concurrent procedures. Second, the comparison focused strictly on the operative costs associated with fixation of clavicle fractures. A more detailed cost-benefit model, including time off work, income lost, the need for therapy, and complications, was beyond the scope of this study. Third, this study did not investigate nonfinancial costs associated with removal surgery, such as the psychological and emotional effects of a second surgery. Fourth, data were collected retrospectively from a 5-year period. Over that time, there were likely changes in implant prices because of both the overall economy and changes in hospital-manufacturer contracts. Fifth, this study did not include specific implant costs. Although public list prices for implants are available, these prices do not represent the actual implant costs charged to the patient based on hospital contracts. Publication of these costs is prohibited by the study institution. Most clavicle pins likely have similar costs, whereas clavicle plates may vary in cost, based on factors including the size of the plate and the number and type of screws. Finally, this study did not report clinical outcomes and did not make conclusions as to which method of fixation is superior for fracture care. This information was not important for this study because several retrospective studies have already compared these 2 methods of fixation. Conclusion To the authors knowledge, this study is the first to directly compare individual operative costs between plating and intramedullary devices for midshaft clavicle fracture fixation. The current results showed decreased operative costs for intramedullary devices, despite more frequent use of a second operation for implant removal. For the small subset of patients who require operative intervention, these results are beneficial to both the surgeon and the patient, especially in the current health care environment. Future prospective studies as well as more detailed cost-benefit analyses are needed. References 1. Postacchini F, Gumina S, De Santis P, Albo F. Epidemiology of clavicle fractures. J Shoulder Elbow Surg. 2002; 11(5): Jeray KJ. Acute midshaft clavicular fracture. J Am Acad Orthop Surg. 2007; 15(4): Robinson CM. Fractures of the clavicle in the adult: epidemiology and classification. J Bone Joint Surg Br. 1998; 80(3): Neer CS II. Nonunion of the clavicle. J Am Med Assoc. 1960; 172: Rowe CR. An atlas of anatomy and treatment of midclavicular fractures. Clin Orthop Relat Res. 1968; 58: Robinson CM, Goudie EB, Murray IR, et al. Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial. J Bone Joint Surg Am. 2013; 95(17): Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures: a multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007; 89(1): McKee RC, Whelan DB, Schemitsch EH, McKee MD. Operative versus nonoperative care of displaced midshaft clavicular fractures: a meta-analysis of randomized clinical trials. J Bone Joint Surg Am. 2012; 94(8): Bostman O, Manninen M, Pihlajamaki H. Complications of plate fixation in fresh displaced midclavicular fractures. J Trauma. 1997; 43(5): Poigenfurst J, Rappold G, Fischer W. Plating of fresh clavicular fractures: results of 122 operations. Injury. 1992; 23(4): Wenninger JJ Jr, Dannenbaum JH, Branstetter JG, Arrington ED. Comparison of complication rates of intramedullary pin fixation versus plating of midshaft clavicle fractures in an active duty military population. J Surg Orthop Adv. 2013; 22(1): Duan X, Zhong G, Cen S, Huang F, Xiang Z. Plating versus intramedullary pin or conservative treatment for midshaft fracture of clavicle: a meta-analysis of randomized SEPTEMBER/OCTOBER 2016 Volume 39 Number 5 e881

6 controlled trials. J Shoulder Elbow Surg. 2011; 20(6): Kleweno CP, Jawa A, Wells JH, et al. Midshaft clavicular fractures: comparison of intramedullary pin and plate fixation. J Shoulder Elbow Surg. 2011; 20(7): Houwert RM, Wijdicks FJ, Steins Bisschop C, Verleisdonk EJ, Kruyt M. Plate fixation versus intramedullary fixation for displaced mid-shaft clavicle fractures: a systematic review. Int Orthop. 2012; 36(3): Lenza M, Faloppa F. Surgical interventions for treating acute fractures or non-union of the middle third of the clavicle. Cochrane Database Syst Rev. 2015; 5:CD Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997; 79(4): Zlowodzki M, Zelle BA, Cole PA, et al. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures. On behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005; 19(7): Golish SR, Oliviero JA, Francke EI, Miller MD. A biomechanical study of plate versus intramedullary devices for midshaft clavicle fixation. J Orthop Surg Res. 2008; 3: Wijdicks FJ, Houwert RM, Millett PJ, Verleisdonk EJ, Van der Meijden OA. Systematic review of complications after intramedullary fixation for displaced midshaft clavicle fractures. Can J Surg. 2013; 56(1): Pearson AM, Tosteson AN, Koval KJ, et al. Is surgery for displaced, midshaft clavicle fractures in adults cost-effective? Results based on a multicenter randomized, controlled trial. J Orthop Trauma. 2010; 24(7): Althausen PL, Shannon S, Lu M, O Mara TJ, Bray TJ. Clinical and financial comparison of operative and nonoperative treatment of displaced clavicle fractures. J Shoulder Elbow Surg. 2013; 22(5): e882 Copyright SLACK Incorporated