Share this article on:

The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center

Mcphillamy, Austin MD; Gurnea, Taylor P. BS; Moody, Alastair E. BS; Kurnik, Christopher G. BS; Lu, Minggen PhD

doi: 10.1097/BOT.0000000000000721
Supplement Article

Objectives: In today's climate of cost containment and fiscal responsibility, generic implant alternatives represent an interesting area of untapped resources. As patents have expired on many commonly used trauma implants, generic alternatives have recently become available from a variety of sources. The purpose of this study was to examine the clinical and economic impact of a cost containment program using high quality, generic orthopaedic locking plates. The implants available for study were anatomically precontoured plates for the clavicle, proximal humerus, distal radius, proximal tibia, distal tibia, and distal fibula.

Design: Retrospective review.

Setting: Level II Trauma center.

Patients: 828 adult patients with operatively managed clavicle, proximal humerus, distal radius, proximal tibia, tibial pilon, and ankle fractures.

Intervention: Operative treatment with conventional or generic implants.

Results: The 414 patients treated with generic implants were compared with 414 patients treated with conventional implants. There were no significant differences in age, sex, presence of diabetes, smoking history or fracture type between the generic and conventional groups. No difference in operative time, estimated blood loss or intraoperative complication rate was observed. No increase in postoperative infection rate, hardware failure, hardware loosening, malunion, nonunion or need for hardware removal was noted. Overall, our hospital realized a 56% reduction in implant costs, an average savings of $1197 per case, and a total savings of $458,080 for the study period.

Conclusions: Use of generic orthopaedic implants has been successful at our institution, providing equivalent clinical outcomes while significantly reducing implant expenditures. Based on our data, the use of generic implants has the potential to markedly reduce operative costs as long as quality products are used.

Level of Evidence: Therapeutic Level III.

*Bay Street Orthopaedics, Petoskey, MI;

Reno Orthopaedic Clinic, Reno, NV;

University of Nevada School of Medicine, Reno, NV; and

§Department of Biostatistics, University of Nevada, School of Community Health Sciences, Reno, NV.

Reprints: Austin Mcphillamy, MD, Bay St Orthopaedics, 4048 Cedar Bluff Drive, Suite 1, Petoskey, MI 49770 (e-mail: amcphil@gmail.com).

Research Grant for this Publication received from Smith & Nephew.

The authors report no conflict of interest.

Accepted September 19, 2016

Back to Top | Article Outline

INTRODUCTION

In the current health care environment, there has been increased awareness in the availability and effectiveness of generic orthopaedic implants and their contribution to cost containment. As generic implants continue to be developed for various orthopaedic applications, it is imperative to demonstrate that these products do in fact provide clinical outcomes comparable with traditional implants. The total United States orthopaedic trauma implant market is estimated to be valued at over $5.3 billion by 2016.1 The potential economic impact of generic orthopaedic implant use as a cost containment strategy between the hospital, surgeon, patients, and payors cannot be understated. Although their successful use has been demonstrated by several smaller previous studies2,3 widespread use of generic implants has not been realized despite the adoption of generics in the pharmaceutical industry. The purpose of this study is to demonstrate the financial implications of such a cost containment program using modern locking plate implant designs and to examine the clinical outcomes associated with the use of these implants.

Back to Top | Article Outline

MATERIALS AND METHODS

After approval by the institutional review board, 3 of the orthopaedic traumatologists at our institution adopted the use of generic precontoured periarticular plates (Orthopaedic Implant Company, Reno, NV) beginning first in May 2013 then successively thereafter as other implants became available. Despite a significantly lower cost, these constructs were biomechanically tested as equivalent to major implant company products before the initiation of the project. Review of our trauma database identified patients with operatively managed clavicle, proximal humerus, distal radius, proximal tibia, tibial pilon, and ankle fractures treated with generic implants. These patients were then compared with patients treated operatively with conventional implants before the utilization and availability of generic implants for the aforementioned applications. All patients were treated using standard fixation techniques for each injury pattern and underwent similar postoperative protocols. They were followed in clinic at 2 weeks, 6 weeks, 3 months, and 6 months intervals with physical exam and radiographs. Chart review was undertaken to obtain basic demographic variables such as age, sex, smoking, and diabetic history. Hospital records were analyzed to identify operative time, estimated blood loss (EBL) and any adverse intraoperative events. Injury radiographs were reviewed to determine fracture classification.

Clinic charts and radiographs were examined to compare rates of malunion, nonunion, hardware failure, infection, and symptomatic hardware requiring removal. These are referred to in our analysis as post-operative complications. All clinic charts and postoperative radiographs were reviewed by blinded authors (T.P.G., A.E.M., C.K.) to minimize bias. Hospital financial records were appraised to determine operative implant costs.

Data were analyzed using SAS (Statistical Analysis System) version 9.2 for Windows by a statistician at the University of Nevada, Reno (ML). Descriptive statistics were used to describe the data. Two-sample t-tests were applied to detect the differences of means for continuous variables and χ2 and Fisher exact tests were performed to test the differences of proportions for categorical variables between conventional and generic groups. Level of significance was set at P < 0.05.

Back to Top | Article Outline

RESULTS

Review of our institutional database identified 414 patients treated with generic implants which were compared with a consecutive series of 414 patients with similar injuries treated with conventional implants before the arrival of generic options. Each specific injury and implant was addressed.

Back to Top | Article Outline

Clavicle

There were 134 patients in the generic group and 134 in the conventional group. The average age between the conventional and generic groups was 36.1 (16.4) and 36.8 (17.0), respectively (P = 0.73). The conventional group was 84% male, whereas the generic group was 86% male (P = 0.49). In the conventional group, 13 (9.7%) were smokers and in the generic group 18 (13.4%) were smokers (P = 0.30). There were 2 (1.5%) diabetics in conventional group and 3 (2.2%) in the generic group (P = 0.65). The Orthopaedic Trauma Association (OTA) fracture classifications and their distribution between treatment groups were similar. There were no significant differences in age, sex, smoking, diabetes, or fracture type between the 2 groups.

All fractures were treated with precontoured superior clavicular locking plates placed through a standard open superior approach. There was no difference in operative time or EBL with an average time of 41 minutes and EBL of <5 mL in the conventional group and 39 minutes and <5 mL in the generic group (P = 0.44, P = 1.0). No intraoperative problems with instrumentation were encountered.

All fractures in both groups healed and no cases of nonunion, malunion, or infection were reported. However, 9 (15%) patients in conventional group and 1 (2%) in the generic group required hardware removal secondary to hardware prominence (P = 0.008). This difference was of statistical significance.

Total clavicle implant costs were $205,395 ($1532/case) in conventional cases and $101,974 ($761/case) in generic cases. The average savings per case was $772 in implants alone. Overall, our hospital realized an average 50% reduction in implant costs per case, resulting in $103,421 savings for the study period.

Back to Top | Article Outline

Proximal Humerus

There were 35 patients in the generic group and 35 in the conventional group. The average ages of the conventional and generic groups were 60.4 (14.1) and 60.5 (14.2), respectively (P = 0.98). The conventional group was 50% male, whereas the generic group was 44% male (P = 0.61). In the conventional group, 4 (11.4%) were smokers and in the generic group 9 (25.7%) were smokers (P = 0.11). There were 2 (5.7%) diabetics in conventional group and 1 (2.9%) in the generic group (P = 0.86).). The OTA fracture classifications and their distribution between treatment groups were similar. There were no significant differences in age, sex, smoking, diabetes, or fracture type between the 2 groups.

All fractures were treated with precontoured proximal humeral locking plates placed through a standard deltopectoral approach. There was no difference in operative time or EBL with an average time of 56 minutes and EBL of 133 mL in the conventional group and 53 minutes and 126 mL in the generic group (P = 0.56, P = 0.68). No problems with instrumentation were encountered.

Postoperative complications occurred in 9 (29%) of patients in conventional group and 7 (30%) of generic group (P = 0.32). There were 5 cases of varus malunion and 4 cases of screw penetrance in the conventional group and 4 cases of varus malunion and 3 cases of screw penetrance in the generic group. Statistical analysis demonstrated no difference in infection rates, malunion, nonunion, hardware failure, or symptomatic hardware requiring removal.

Total proximal humeral implant costs were $118,538 ($3386/case) in conventional cases and $56,175 ($1605/case) in generic cases. The average savings per case was $1782 in implants alone. Overall, our hospital realized an average of 47% reduction in implant costs per case, resulting in $62,363 savings for the study period.

Back to Top | Article Outline

Distal Radius

There were 76 patients in the generic group and 76 in the conventional group. The average ages of the conventional and generic groups were 56.6 (12.5) and 55.3 (16.8) respectively (P = 0.63). The conventional group was 24% male, whereas the generic group was 30% male (P = 0.51) The OTA fracture classifications and their distribution between treatment groups were similar. There were no significant differences in age, sex, smoking, diabetes, or fracture type between the 2 groups.

All fractures were treated with precontoured volar distal radial locking plates placed through a standard volar (flexor carpi radialis) approach. There was no difference in operative time with an average of 37.4 minutes in the conventional group and 38.4 minutes in the generic group (P = 0.68). The average EBL was 2.9 mL in the conventional group and 5.0 mL in the generic group (P = 0.42). No problems with instrumentation were encountered.

All patients healed in both groups and no cases of infection were reported. Postoperative complications occurred in 7 (9.2%) of patients in conventional group and 6 (7.9%) of generic group (P = 0.66). These included 6 cases of dorsal malunion and one postoperative extensor tendon rupture in the conventional group. Four cases of dorsal malunion and 2 extensor tendon ruptures were observed in the generic group. Statistical analysis demonstrated no difference in infection rates, malunion, nonunion, hardware failure, or symptomatic hardware requiring removal.

Total distal radial implant costs were $168,370 ($2215/case) in conventional cases and $79,610 ($1047/case) in generic cases. The average savings per case was $1167 in implants alone. Overall, our hospital realized an average of 47% reduction in implant costs per case, resulting in $88,760 savings for the study period.

Back to Top | Article Outline

Proximal Tibia

There were 28 patients in the generic group and 28 in the conventional group. The average ages for patients in the conventional and generic group were 52.3 (16.4) and 53.4 (18.4), respectively (P = 0.82). The conventional group was 46% male and the generic group was 54% male (P = 0.43). In the conventional group, 7 (25%) were smokers and in the generic group 3 (11%) were smokers (P = 0.45). There were 2 (7.1%) diabetics in the conventional group and 1 (3.5%) in the generic group (P = 0.95). The OTA fracture classifications and their distribution between treatment groups were similar. There were no significant differences in age, sex, smoking, diabetes, or fracture type between the 2 groups.

Lateral and medial precontoured locking proximal tibia plates were available for treatment of all patients. Average operative time was 47 minutes in the conventional group and 55 minutes in the generic group (P = 0.06). There was no difference in EBL with an average of 10 mL in the conventional group and <5 mL in the generic group (P = 0.18). No problems with instrumentation were encountered.

All fractures in both groups healed. Postoperative complications occurred in 5 (17.8%) of patients in conventional group and 3 (10.7%) in the generic group (P = 0.54). In the conventional group, there was one case of postoperative infection requiring debridement, one varus malunion, and 3 patients who underwent hardware removal for symptomatic hardware. In the generic group, there was one varus malunion and 2 cases of prominent hardware required removal. Statistical analysis demonstrated no difference in infection rates, malunion, nonunion, hardware failure, or symptomatic hardware requiring removal.

Total proximal tibial implant costs were $133,392 ($4764/case) in conventional cases and $72,072 ($2574/case) in generic cases. The average savings per case was $2190 in implants alone. Overall our hospital realized an average 54% reduction in implant costs per case, resulting in approximately $61,320 savings for the period studied.

Back to Top | Article Outline

Tibial Pilon

There were 17 patients in the generic group and 17 in the conventional group. The average age of the conventional and generic groups were 47 (14) and 56 (14.3), respectively (P = 0.08). The conventional group was 62% male, whereas the generic group was 81% male (P = 0.25). In the conventional group, 7 (41.1%) were smokers and in the generic group, 4 (23.5%) were smokers (P = 0.08). There was 1 (5.9%) diabetic in conventional group and none in the generic group (P = 1). The OTA fracture classifications and their distribution between treatment groups were similar. There were no significant differences in age, sex, smoking, diabetes, or fracture type between the 2 groups.

Medial and anterolateral precontoured locking distal tibia plates were available for the treatment of patients and were placed through standard approaches. There was no difference in operative time or EBL with an average time of 51 minutes and EBL of <5 mL in the conventional group and 45 minutes and <5 mL in the generic group (P = 0.42, P = 0.86). No problems with instrumentation were encountered.

Postoperative complications occurred in 6 (35.3%) of patients in conventional group and 5 (29.4%) of generic group (P = 0.74). In the conventional group, there were 3 infections and 3 nonunions requiring reoperation, whereas in the generic group there were 4 cases of delayed union and one postoperative infection requiring reoperation. Statistical analysis demonstrated no difference in infection rates, malunion, nonunion, hardware failure, or symptomatic hardware requiring removal.

Total distal tibia implant costs were $117,419 ($6907/case) in conventional cases and $69,411 ($4083/case) in generic cases. The average savings per case were $2824 in implants alone. Overall our hospital realized an average of 59% reduction in implant costs per case, resulting in $48,008 savings for the period studied.

Back to Top | Article Outline

Ankle Fractures

One hundred twenty eight patients were treated with generic implants and 128 with conventional implants. The average ages of the conventional and generic groups were 50.7 (17.6) and 47 (18.0) respectively (P = 0.13). In the conventional group, 44% were male and 46% male in the generic group (P = 0.94). In the conventional group, 31 (24.2%) were smokers and in the generic group, 26 (46.1%) were smokers (P = 0.11). There were 10 (7.8%) diabetics in conventional group and 9 (7.0%) in the generic group (P = 0.8). The OTA fracture classifications and their distribution between treatment groups were similar. There were no significant differences in age, sex, smoking, diabetes, or fracture type between the 2 groups.

Distal fibular precontoured locking plates and 1/3 tubular locking small fragment plates were available for treatment of these fractures. There was no difference in operative time or EBL with an average time of 38 minutes and EBL of <5 mL in the conventional group and 31 minutes and <5 mL in the generic group (P = 0.17, P = 0.24). No problems with instrumentation were encountered.

Postoperative complications occurred in 9 (7.0%) of conventional patients and 10 (7.8%) of generic patients (P = 0.88). The conventional group had 2 nonunions, 3 infections, 3 cases of symptomatic hardware requiring repeat operative intervention and one case of reflex sympathetic dystrophy. In the generic group, there were 2 cases of nonunion, one fibular malunion, 4 infections, and 3 cases of symptomatic hardware requiring repeat operative intervention. Statistical analysis demonstrated no difference in infection rates, malunion, nonunion, hardware failure, or symptomatic hardware requiring removal.

Total ankle implant costs were $210,432 ($1644/case) in conventional cases and $116,224 ($908/case) in generic cases. The average savings per case was $736 in implants alone. Overall, our hospital realized an average 55% reduction in implant costs per case, resulting in $94,208 savings for the study period.

Back to Top | Article Outline

Total Savings

The 414 patients treated with conventional implants incurred $953,546 in implant costs, whereas the 414 generic patients incurred $495,466 in implant expenditures (Table 1). Generic implant use resulted in an average savings per case of $1197. The total savings during the study period amounted to $458,080.

TABLE 1

TABLE 1

Back to Top | Article Outline

DISCUSSION

The estimated value of the orthopaedic trauma device market in 2016 is nearly $5.3 billion and is rapidly increasing. In 2009, the US plate and screw market was estimated at $2.05 billion dollars and is expected to increase to $2.26 billion by 2016. With the increasing use of locking technology, the locking plate market is estimated to exceed $842 million in 2016.1 The first modern locking plate was described by Ramotowski in 1991 and its patents have long expired.4 As a result, the locking constructs which are the topic of this study have been off patent for several years. Interestingly, unlike other businesses such as the pharmaceutical industry, generic orthopaedic implant options have only recently become available. Although there is a tremendous amount of money and development invested into new implant designs there is not always a strong correlation with improved clinical outcomes.2 This cycle continues to escalate the costs of care.

Despite hundreds of articles demonstrating the clinical equivalence of generic medications in the literature, only 2 scientific articles were able to be found on generic orthopaedic implants. Waddell et al published a clinical trial of generic total hip implants in Canada on 150 patients who were followed for over 2 years.5 The use of generic implants resulted in no increase in complication rates and general improvement in hip scores. The second paper was published by Althausen et al in 2014. This paper evaluated the clinical and economic benefits of generic 7.3 mm cannulated screws' use in the treatment of femoral neck fractures and percutaneous sacroiliac fixation. Authors demonstrated a 70% reduction in implant costs with no difference in clinical outcomes.6 Our paper seeks to add to the work of these authors in documenting the economic benefit of generic locking plate use with similar clinical results to conventional implants.

Our study demonstrates the significant cost savings associated with generic implants, realizing a 56% savings overall in implant costs compared with conventional implants equating to an average savings of $1197 per case for the studied implants. The total amount saved was $458,080 over the study period while demonstrating no significant effect on intraoperative or postoperative outcome measures. The total savings that could be realized at our trauma center could have been even greater but only 3 of 5 traumatologists currently use generic implants. In addition, new generic implant designs, such as cephalomedulary nails, continue to be released. However, these have not been used at our institution long enough to study effectively.

As outlined in previous work, multiple barriers to generic implant use exist. Perhaps most important is the lack of surgeon confidence in a generic product. Inaccurate perception of generic implants is propagated by surgeons, implant companies, and hospitals alike. Although biomechanical equivalence is confirmed preoperatively and all implants approved for use in the United States must meet Food and Drug Administration standards, clinical efficacy must be demonstrated. Because of a general reticence to adopt any type of generic implant, we selected implants that are mechanically sound, conceptually simple, and require no sales representation for implantation. Surgeons must only pick a plate of the appropriate shape and length, drill with a single size drill bit, and measure screws of the appropriate length. This study evaluates use of very simple devices using techniques with which fracture surgeons have had experience for years. Our data set compares patients treated by traumatologists over a 2-year period, one group with generic implants and one with conventional implants. Equivalence was demonstrated across all operative, postoperative, and radiographic parameters. The only difference was significant cost savings.

Another barrier to change is surgeon's conflict of interest. At many institutions, orthopaedic traumatologists are paid consultants or have royalty agreements with implant companies. This can make it difficult to effect change. At our institution, none of our trauma surgeons has a consulting agreement or royalty agreement with any of the major branded implant companies. This may play a role in easier adoption of generic implants at our facility. Certainly, conflicts of interest do arise when such relationships exist. This has been a major factor in recent Department of Justice investigations of total hip and knee arthroplasty implant use. For institutions that fear loss of research funding, we advocate that money saved from generic implant use can be appropriated towards research and service line reinvestment. This will free institutions of manufacturer bias or single vendor support.

Another concern raised during generic implementation involved the worry that existing conventional vendors and sales representatives would alter the level of service they provide or increase the prices on unique implants and instrumentation. At our institution, the use of generic alternatives over the past 4 years has stimulated better service from conventional companies who wish to preserve their market share. In addition, such dramatic savings have provided the hospital with the ability to more effectively negotiate prices on conventional items such as intramedullary nails and plate and screw constructs. Matrix pricing has become the norm at our institution with hemiarthroplasty and nail constructs which have resulted in massive savings as well. As a result, the use of generic alternatives has been successful on many levels.

Another theoretical barrier to generic implant use is concerns of patients' perceptions. One article by Sewell et al describes these concerns regarding generic medication.3 Using generic medications with similar efficacy to brand name medications for underinsured populations clearly has its advantages. However, 4 focus groups with 30 community members from Alabama, ¼ of whom were uninsured, and more than half with a high school education or less revealed that many misconceptions of generic medicine existed. Common themes included perceptions that generics are not “real” medicine, that generics are only for “minor” illnesses, and that the medical system cannot be trusted. They concluded that although education about generics could help overcome misinformation, “overcoming mistrust of the medical system and the sense of having to settle for generics because of poverty may be more challenging.”3 Although these perceptions exist, the World Health Organization believes that strategies to promote generic substitution should be included in national medicine policies.7

Cost-effectiveness and comparative effectiveness evaluations are increasing in prevalence in orthopaedic peer review literature. An implant or intervention with equivalent effectiveness that costs 50%–60% less is clearly cost-effective and beneficial. Assuming biomechanical equivalence, generic products have a huge potential for cost savings. The credibility and viability of generic implants is directly tied to the capacity of the scientific community to properly test generic implants and ensure that their quality and effectiveness are equivalent to conventional implants. The intramedullary nail market is expected to increase to $788 million by 2016 in addition to the $574 million in cephalomedullary nails. In 2016, the external fixation market is estimated to be $555 million, whereas the plate and screw market $2.26 billion.1 These numbers are staggering. If the 40%–60% reduction in costs shown in this study could be applied to other implants, orthopaedic trauma surgeons could have a massive effect on the economics of the healthcare crisis. Given the fact that many of our patients are uninsured or underinsured, we believe that it is our duty to be cost conscious as long as biomechanical equivalency and clinical performance remain equal.

Back to Top | Article Outline

CONCLUSIONS

Perhaps the most crucial impact of generic implant utilization is the renewed focus on surgeons as end users of health care resources. The concept of generic implants demonstrates that surgeons do have the capability to positively impact the escalating cost of health care without compromising patient safety or quality of outcomes. As health care resources become more limited if not scarce, innovative cost saving programs will be essential to physicians as a means of preserving patient care standards within an evolving and increasingly complex health care delivery system. Use of generic locking plates has been a very successful endeavor at our institution, demonstrating a 56% savings overall in implant costs compared with conventional implants equating to an average savings of $1197 per case and total savings of $458,080 over the study period. Hospital implant costs were decreased significantly without any associated increase in complication rate or change in radiographic outcome. This has profound implications for the treatment of trauma patients as patents have expired on many other products such as intramedullary nails, other locking plates and disposable items such as drill bits. Generic implant usage has the potential to markedly reduce operative costs in a manner similar to the generic pharmaceutical industry. As long as quality products are used, patient care is unaffected and cost savings can be realized. A portion of savings from such a change can be reinvested in the hospital trauma program to support OTA/American Association of Orthopaedic Surgeons position statement guidelines, assist in gain sharing and co-management efforts and positively affect the cost of fracture implants in the future.

Back to Top | Article Outline

REFERENCES

1. U.S. Market for Orthopedic Trauma Devices. Vancouver, BC, Canada: Data Research Inc; 2010. Available at: www.idataresearch.net. Accessed September 1, 2016.
2. Daigle ME, Weinstein AM, Katz JN, et al.. The cost-effectiveness of total joint arthroplasty: a systematic review of published literature. Best Pract Res Clin Rheumatol. 2012;26:649–658.
3. Sewell K, Andreae S, Luke E, et al.. Preceptions of and barriers to use of generic medications in a rural African American population, Alabama, 2011. Prev Chronic Dis. 2012:E142.
4. Ramotowski W, Granowski R. Zespol. An original method of stable osteosynthesis. Clin Orthop Relat Res. 1991;272:67–75.
5. Waddell JP, Morton J. Generic total hip arthroplasty. Clin Orthop Relat Res. 1995:109–116.
6. Althausen PL, Kurnik CG, Shields T, et al.. Clinical and economic impact of generic 7.3 mm cannulated screw use at a level II trauma center. Am J Orthop (Belle Mead NJ). 2014;43:405–410.
7. Cameron A, Mantel-Teeuwisse AK, Leufkens HG, et al.. Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved? Value Health. 2012;15:664–673.
Keywords:

orthopaedic trauma; cost containment; generic implants

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.