Abstract
Introduction:
The escalation of United States (U.S.) spine surgery volume has been accompanied by considerable advancements in our understanding of spine physiology and technology. Together with implant development over the past decades, these improvements have led to shifts in implant usage. This investigation aimed to elucidate the trends in spinal implant utilization in the U.S. from 2013 to 2022.
Materials and Methods:
Spine implant utilization and pricing averages between 2013 and 2022 were extracted from Orthopedic Network News. The total sample composed of 664,310 spine procedure purchase orders. Prices were adjusted for inflation based on 2022 prices. Trends were analyzed using linear regression.
Results:
The U.S. spine procedure volume increased significantly from around 800,000 procedures per year in 2013 to over 1.1 million in 2022, with 73% comprising lumbar and cervical fusions. The proportion of procedures performed in patients over 64 years old increased significantly in both lumbar and cervical cases, constituting 50% and 37% of procedures, respectively. In lumbar spine in 2022, 46% of procedures utilized both pedicle screws (PSs) and interbody devices, 37% PSs only, and 13% interbody devices only. Lumbar PS price decreased significantly to $923 each despite stable lumbar and cervical fusion procedure costs. Polyetheretherketone (PEEK) and allograft interbody device usage declined while metal increased significantly.
Conclusion:
Nationwide spine procedure volume rose notably from 2013 to 2022, with the majority constituting lumbar and cervical fusions. The most frequent treatment for a lumbar fusion is a PS construct with an interbody fusion device. Interbody fusion device materials witnessed decline in the use of PEEK and allograft, with metals becoming the preferred material.
Level of Evidence:
III
Keywords: Cervical fusion, implant pricing, lumbar fusion, osteobiologics
INTRODUCTION
Spine procedures in the United States (U.S.) represent a significant portion of neurosurgical and orthopedic surgeries, reflecting advancements in medical technology and an increasing demand for interventions that address back pain and spinal disorders.[1] Over the past several decades, the volume of spine surgeries has shown a steady increase, with continued upward trends in spinal fusions, disc replacements, and vertebroplasties.[2,3] As the U.S. population ages and an upward trend in obesity and its related conditions continue, increasing rates of osteoarthritis and joint degeneration can be expected to contribute to further demand for spinal procedures.[4,5]
An estimated 50% of adults over 65 years old experience back pain, a number only expected to rise.[6,7] Spinal fusions have witnessed a growing list of indications including spondylolisthesis with instability, spinal deformity, disc degeneration, recurrent disc herniation, and severe spinal stenosis.[3,8] The effectiveness of these procedures is reflected in the improved quality of life and reduced long-term disability in patients suffering from chronic back conditions.[9] As such, the growing prevalence of spine procedures is becoming an increasingly vital component of health-care services, prompting the need for ongoing evaluation of its implementation.
While trends in spinal surgery techniques have evolved, research on spine implant pricing and their utilization are scarce. Studies to date have often been limited to select academic centers or have focused on the distinction between inpatient and outpatient settings, leaving a gap in comprehensive pricing and usage data across the country. To address this issue, the Orthopedic Network News (ONNs)[10] releases an annual report that offers a more inclusive picture. The publication further examines the patterns of spine implant utilization, trends in surgical technique, and the financial impact associated with them. Recognizing the limitations of previous research and the increasing demand for spine procedures, this study aims to identify trends in U.S. spine implant and technology use, as well as the associated prices, from 2013 to 2022.
MATERIALS AND METHODS
Spinal implant utilization and pricing averages between 2013 and 2022 were collected from ONNs, the largest publicly available implant registry.[10] They publish data from Curvo Research Network, their parent company. The resource is a quarterly publication and online information service on pricing and quality issues in orthopedics. Each year, ONN publishes a spine surgery newsletter in which this specific data on spinal implant pricing, procedure breakdown, and industry updates can be found.
From 2013 to 2022, nationwide utilization and pricing averages were based on a sample of 664,310 spine procedure purchase orders. Most recent estimates from 2022 were based on procedures in 244 U.S. hospitals. Data categories included types of spine procedure performed, lumbar and cervical fusion statistics, average selling price (ASP) per procedure, and ASP for specific implant materials. All prices were adjusted to their equivalence in 2022 U.S. dollars using inflation rates reported by the Bureau of Labor Statistics (Washington D.C.). Trends were analyzed using simple linear regressions.
RESULTS
Spine implant sales reached an estimated $9.01 billion in 2022, up from $8.78 (adjusted) in 2013. Parallel to this, the volume of spine procedures requiring vertebroplasty or instrumentation increased significantly from around 800,000 procedures per year in 2013 to over 1.1 million in 2022 (β =28,461, P < 0.05). Of note, cervical disc arthroplasty volume grew significantly from <20,000 procedures in 2013 to nearly 50,000 procedures in 2022 (β =3645, P < 0.01).
About 73% of instrumented procedures in 2022 consisted of lumbar and cervical fusions. From a demographic standpoint, the proportion of lumbar fusions that were performed for female patients dropped significantly from 58% to 52% (β = −0.4, P < 0.05), although no such change was seen in cervical fusions. The proportion of fusion procedures, however, in patients over 64 years old increased significantly in both lumbar (β =0.92, P < 0.01) and cervical (β =1.31, P < 0.01) cases, now constituting 50% and 37% of instrumented procedures, respectively. From 2013 to 2022, there was no significant change in the number of lumbar levels fused, but the average number of cervical levels fused per procedure increased significantly from 1.89 to 2.29 (β =0.058, P < 0.01).
Lumbar fusion technique has not significantly changed in the past decade, with 46% of procedures using both pedicle screws (PSs) and interbody devices, 37% using PSs only, and 13% using interbody fusion only in 2022 [Figure 1]. Cervical fusions, however, saw a significant increase in posterior cervical screw usage (β =1.02, P = 0.001), while interbody fixation alone and cervical plate with interbody device usage remained relatively stable). The inflation-adjusted costs of lumbar and cervical fusion procedures did not change significantly, costing $13,457 and $5184, respectively, in 2022. Interestingly, the inflation-adjusted price of a lumbar PS decreased significantly from $1299 in 2013 down to $923 in 2022 (β = −29.97, P < 0.01), a nearly 30% reduction when adjusted for inflation.
Figure 1.
Lumbar fusion technique implementation from 2013 to 2022.[10] IBF = Interbody fusion, PS = Pedicle screw
In terms of biologics utilization in lumbar fusions, 50% of surgeries included demineralized bone matrix or allograft bone, 31% included bone morphogenetic proteins (BMPs), 12% included bone substitutes, and 10% included cell-based matrix (CBM) [Figure 2]. Of these, only bone substitute utilization from 2013 to 2022 changed significantly, decreasing from 23% in 2013 (β = −1.62, P < 0.01).
Figure 2.
Biologics usage in lumbar fusions from 2013 to 2022.[10] DBM = Demineralized bone matrix, BMP = Bone morphogenetic protein, CBM = Cell-based matrix
In 2022, breakdown of interbody fusion device material usage demonstrated that 21% of procedures used polyetheretherketone (PEEK), 65% used metals such as titanium and trabecular metal, and 13% used allograft [Figure 3]. From 2013 to 2022, interbody fusion device materials experienced significant changes in utilization with PEEK (β = −5.83, P < 0.001) and bone (β = −1.95, P < 0.05) utilization showing a significant decline while metal has grown to become the preferred material (β =8.18, P < 0.001). Of note, allograft interbody ASP decreased significantly, from $3685 in 2013 to $2004 in 2022 (β = −184, P < 0.01), while metal and PEEK devices did not experience significant change in ASP.
Figure 3.
Interbody Fusion Device Material Utilization from 2013 to 2022.[10] PEEK = Polyetheretherketone
In 2022, the top five leaders in the spinal implant market were Medtronic with 23.2% of the share, NuVasive with 8.9%, Stryker with 8.7%, and DePuy Synthes and Globus Medical each with 8.3% of the market share. In this same year, Medtronic had the greatest share of cervical plate market at 37%, NuVasive had the greatest share of lateral approach thoracolumbar plate market at 32%, and Globus Medical led interbody device sector at 24%, with Medtronic immediately behind at 22%.
DISCUSSION
Our study documents the current trends in spine procedure volume, utilization, and pricing over the recent decade. Growing volume aligns with the number of spine surgeons in the U.S., which has increased by 9.6% between 2012 and 2017.[11] With over a million instrumented spine surgeries performed nationwide each year, indications and access-to-care analytics are more critical than ever. In addition, Beschloss et al. point to insurance developments like the Affordable Care Act as contributors to over 100% increases in certain spine procedures between 2004 and 2015.[12] Greenberg et al. highlight a similar trend, where authors found Medicaid expansion under the Affordable Care Act to be associated with an economically and statistically significant increase in spine surgery volume.[13] Heightened availability and accessibility are therefore likely to have major roles in the ballooning spine market.
An increase in the number of surgeries could also be due to expanding indications in an increasingly aging population. Some of the first documented spinal fusions in the late 1800s and early 1900s were performed to address instability and/or deformity from trauma or scoliosis.[14] In modern times, indications have expanded to include a broader spectrum of conditions including degenerative spondylolisthesis/scoliosis and spinal neoplasms, with the majority of procedures now performed for degenerative etiologies.[15,16] These trends therefore reflect broader societal and health-care shifts such as the aging population, advancements in surgical safety that permit the treatment of older patients, and broader indications for surgery. As the aging population continues to require and undergo spine surgery, with outcomes improving or remaining stable despite the complexity that age adds to surgical risk, it is implied that age alone should not be a deterrent to considering surgery.[17,18]
Demographically, our study noted that the proportion of lumbar and cervical fusion procedure patients that were 65 and older increased significantly from 2013 to 2022. This is in line with trends observed in the prior decade; Vonck et al. noted that despite increases in average age and number of comorbidities, length of stay remained constant and a decrease in mortality was seen across the study period.[19] Further examination of outcomes and mortality rates within older patient populations is needed, as medical knowledge and technology better equips us to care for elderly patients in the perioperative period.[16,19,20,21]
According to our study, there has been no significant change observed in trends of lumbar fusion approach (i.e., PS instrumentation with posterolateral bone grafting vs. PSs with interbody fixation vs. standalone interbody fixation). Nearly half of 2022 lumbar fusions implemented PS fixation together with interbody fusion while over a third opted for sole PS fixation, a breakdown that has remained stable since 2013. This finding demonstrates that surgeons continue to trust the increased stability that a combination interbody/PS system gives to their patients.
PS constructs have been in use since the mid twentieth century with high rates of effectiveness in spinal reconstruction.[22,23,24] Cited disadvantages of screw-only constructs have been attributed to inadequate decompression of the foramen without restoration of disc height via interbody fixation or the absence of adequate load sharing through the anterior column.[25] In response, PS constructs began to incorporate interbody devices like those seen in posterior lumbar interbody fusion or transforaminal lumbar interbody fusion to provide anterior column support without the need for an anterior incision.[26] The preference for PS constructs with interbody device fixation is likely due to more stable bony fixation when compared with use of the PSs alone due to load sharing principles and maximizing surface areas of bony contact.[27] Posterolateral fusion alone without interbody fixation may be reserved for elderly patient populations with instability, requiring central decompression without significant foraminal stenosis. Utilizing this approach can minimize operative time while providing adequate relief of symptoms in a more at-risk patient population.[28]
Cervical spinal fusions saw significant changes in methodology from 2013 to 2022, though procedure cost did not change. More recent implementation and growing confidence of posterior cervical biomechanics explains its growing share of procedures. Advancements in computer-assisted navigation systems and robots have also improved the safety and accuracy of screw placement, benefiting patient outcomes.[29] While cervical plates with interbody devices remain the predominant cervical fusion technique, our study noted a drop in sole cervical plate fusions over the past decade. This is likely due to standalone interbody fixation systems with integrated screw systems for anterior approaches, which are lower profile and may reduce the risk of dysphagia and injury to the esophagus and other adjacent structures.[30] Furthermore, the cost stability of both lumbar and cervical fusion procedures, despite the overall growth in spinal surgeries, suggests that other components may be offsetting the reduced cost of PSs.
Biologics remain an important factor in spinal fusions as they enhance specific cellular activity in hopes of promoting arthrodesis in the setting of instability or deformity.[31] In 2022, half of all procedures included demineralized bone matrix or allograft bone; 31% included BMPs; 12% included bone substitutes; 10% included CBM. Demineralized bone matrix (DBM) is frequently used due to its osteoconductive and osteoinductive properties and acts by facilitating the endogenous release of osteogenic agents to the surgical site, thus enhancing bone repair and healing.[32] DBM does not, however, offer structural support and is better suited for filling defects and cavities rather than providing mechanical stability.[33] Furthermore, while often highly efficacious, BMPs and CBM pose significant risks such as infection and are not always suitable.[34,35] Choice of biologic for spinal fusion is influenced by spinal region, surgeon preference, surgical training, health system formulary, and cost. As a result, more critical investigation is needed to better understand their uses and effects.[34] In addition, pricing of biologics must be further analyzed to understand the rising national spine surgery bill despite decreasing prices of other implants such as PSs.
Interbody fusion device materials witnessed significant change in the past decade. Metals such as titanium and trabecular metal now comprise most of these devices while materials such as PEEK have significantly declined. While PEEK was favored previously for its radiolucency and a modulus of elasticity that is comparable to bone, titanium is recognized for its osteoinductive properties, potentially enhancing the fusion rate.[36] Studies have found no significant functional differences between PEEK and metal cages, but better fusion rate and initial stability were observed with metal cages, likely contributing to decline in PEEK usage.[37,38] Moreover, although there was no significant change in PEEK or metal device prices during this time span, a significant drop in the ASP of allograft interbody devices prompts further monitoring of its utilization over the coming years.
From an industry standpoint, Medtronic led the spinal implant market in 2022 with a 23.2% share. This dominance was particularly evident in the cervical plate market, where they held 37%. NuVasive, while holding the second greatest overall market share at 8.9%, led the thoracolumbar plate market with nearly a third of the share, pointing to a strategic specialization in this niche. Moreover, Globus Medical not only held a similar overall share but also positioned itself as the leader of the interbody device sector, slightly ahead of Medtronic. This may reflect a targeted approach to capturing market leadership within specific segments rather than diversifying across the entire spinal market. On the other hand, Stryker and DePuy Synthes, each with <10% of market shares, respectively, demonstrated competitive standings but did not dominate in a specific category. This varied competition is likely contributing to a wider spectrum of implant models and decreased implant prices that will further impact implant utilization and technical trends down the line. Finally, the market’s slight increase in total sales amid relatively stable procedure costs suggests a shift toward investment in advanced technologies such as navigation systems and robotics.
A major limitation of this study is its basis on a limited sample of the U.S. hospitals, representing <5% of the national total. Moreover, only spine cases that included industry were included in the ONN database. This included fusions, disk replacements and vertebroplasties. As such, no decompressive procedure was included in this analysis. Furthermore, both regional differences and the impact of the COVID-19 pandemic were unable to be elucidated from this data. Despite these limitations, ONN’s registry remains the most extensive publicly accessible implant database, providing detailed information on spinal procedures and implant utilization for several decades and answering the questions of this study. As innovation in spine procedures progresses, clinical understanding and efficiency will continue to influence implant utilization and pricing trends. Future research should therefore encompass investigations into the long-term effects of various materials and surgical techniques on patient outcomes to ascertain their effectiveness and safety.
The key points of this study suggest certain shifts in spinal surgery techniques and patient demographics, with a rise in instrumented spine procedure volume and a shift toward older patient populations for lumbar and cervical fusions. The increase in the number of levels fused in cervical procedures and the relative increase in usage of posterior cervical screw stabilization systems may reflect our ability to safely address more complex pathology, although further investigation is needed to evaluate this specific trend. The decline in the use of bone substitutes and traditional materials like PEEK and allograft in favor of metals for interbody devices reflect advancements in material science. From an economic perspective, the stability of inflation-adjusted prices for fusion procedures despite the changing materials and techniques could reflect market pressures, increased competition, or improvements in efficiency. Overall, these trends reveal ongoing innovation in spine surgery with a focus on cost-efficiency and value-based health care. Awareness of these shifts is integral in developing more sustainable practices in the health-care economy and potentially improved access to care for the aging population.
CONCLUSION
In the U.S. from 2013 to 2022, spine procedure volume rose notably, with the majority constituting lumbar and cervical fusions. The proportion of patients 65 and older undergoing these procedures increased significantly, demonstrating a shift to older patient populations. The most frequent category of treatment for a lumbar fusion is a PS construct with an interbody fusion device. In the cervical spine, the number of multi-level fusions of three or more vertebra has increased. Biologic materials in lumbar fusions saw a significant decrease in bone substitute utilization. Interbody fusion device materials witnessed a marked decline in the use of PEEK and allograft, with metals becoming the preferred material. Financially, the marginal increase in overall spinal implant sales despite the rising volume of surgeries underscores a shift in cost dynamics within the industry. Significant reductions in the ASP of implants such as PSs and bone substitutes, combined with stable overall procedure costs, suggests increased investment in other technologies such as navigation systems and robotics that continue to drive market sales.
Author contributions
All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Gabrielle Dykhouse. The first draft of the manuscript was written by Gabrielle Dykhouse and all authors reviewed previous versions of the manuscript. All authors read and approved the final manuscript.
Ethics approval
This study was IRB exempt as it was a retrospective database analysis.
Conflicts of interest
Dr. Lynn McGrath is a consultant for Brainlab and Joimax.
Dr. Roger Härtl is a consultant for Depuy Synthes and Brainlab, an advisor for 3D Bio and RealSpine, and receives royalties from Zimmer Biomet.
Funding Statement
Nil.
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