Risk of Pseudoarthrosis After Spinal Fusion: Analysis From the Healthcare Cost and Utilization Project

doi:10.1016/j.wneu.2018.08.026

World Neurosurgery

Volume 120, December 2018, Pages e194-e202

https://doi.org/10.1016/j.wneu.2018.08.026 Get rights and content

Highlights

•
HCUP administrative databases are valuable sources of inpatient data.
•
The pseudoarthrosis risk varies depending on the anatomic site and surgical approach.
•
Levels fused, smoking, and steroid use increased the risk for all fusions.
•
Hypertension and sleep apnea increased the risk in thoracolumbar fusion.
•
A large sample size allows one to uncover trends not seen in previous studies.

Background

Pseudoarthrosis after spinal fusion is an important cause of pain, neurologic decline, and reoperation.

Methods

The Healthcare Cost and Utilization Project State Inpatient Databases were queried in New York, California, Florida, and Washington for adult patients who had undergone new spinal fusion from 2009 to 2011. In accordance with the Healthcare Cost and Utilization Project methods series and analysis guidelines, generalized linear mixed effects models were used to estimate the odds of experiencing postoperative pseudoarthrosis as a function of multivariable patient characteristics, comorbidities, and surgical approach.

Results

Of the 107,420 patients who had undergone cervical fusion, 1295 (1.2%) developed pseudoarthrosis requiring reoperation. On multivariable analysis, the risk factors included posterior (odds ratio [OR], 4.47; 95% confidence interval [CI], 3.92–5.10) and combined (OR, 1.77; 95% CI, 1.33–2.36) approaches, fusion of ≥9 vertebrae (OR, 2.54; 95% CI, 1.38–4.68), smoking (OR, 1.19; 95% CI, 1.05–1.34), and long-term steroid use (OR, 1.89; 95% CI, 1.18–3.00). Of the 148,081 patients who underwent thoracic or lumbar fusion, 2665 (1.8%) developed pseudoarthrosis. Posterior (OR, 0.58; 95% CI, 0.51–0.56) and combined (OR, 0.46; 95% CI, 0.40–0.54) approaches resulted in reduced rates. Fusion of 4–8 vertebrae (OR, 1.52; 95% CI, 1.39–1.67), ≥9 vertebrae (OR, 1.87; 95% CI, 1.49–2.34), hypertension (OR, 1.18; 95% CI, 1.09–1.28), sleep apnea (OR, 1.48; 95% CI, 1.26–1.72), smoking (OR, 1.22; 95% CI, 1.12–1.33), and long-term steroid use (OR, 1.53, 95% CI, 1.08–2.18) resulted in increased rates.

Conclusions

These findings strongly associate several diagnoses with the development of pseudoarthrosis. However, further prospective studies are warranted to establish causation.

Introduction

Symptomatic pseudoarthrosis after spinal fusion procedures is an important cause of postoperative morbidity and reoperation. In a series of scoliosis corrections reported by Ahmed et al.,¹ pseudoarthrosis and surgical site infection were the most common causes of early reoperation. Pseudoarthrosis can present with a combination of axial and radicular symptoms as a result of failure of fusion of a spinal unit. Cost-effectiveness analyses for reoperation for symptomatic pseudoarthrosis illustrate the high and variable cost of such procedures, ranging from $24,000 to $64,000 for lumbar surgeries.2, 3 A number of smaller series have identified risk factors for pseudoarthrosis, including smoking, diabetes, steroid use, and younger age.4, 5, 6 However, to date, no large database studies have been performed to evaluate the risk factors for symptomatic pseudoarthrosis after spinal fusion. The goal of the present study was to identify and quantify the patient characteristics and risk factors for the development of symptomatic pseudoarthrosis after spinal fusion procedures within a large population using a large inpatient database.

Section snippets

Data Source

The State Inpatient Databases (SID), a family of administrative databases developed by the Healthcare Cost and Utilization Project (HCUP) and sponsored by the Agency for Healthcare Research and Quality, were queried to identify patients who had undergone spinal fusion procedures in New York, California, Florida, and Washington from 2009 through 2011. These databases provide robust data regarding inpatient admissions from participating hospitals, including diagnoses and procedures performed, in

Results

A total of 278,257 patients who had undergone new spinal fusion from 2009 and 2011 were identified. Of these patients, 2117 were excluded from the analysis because they had undergone surgery at multiple anatomic sites, and 14,123 patients were excluded because the details were insufficient to determine whether surgery had occurred in the cervical, thoracic, or lumbar spine. Of the remaining 262,017 patients, 109,626 had undergone cervical fusion and 152,391, thoracic or lumbar fusion. Of the

Discussion

To the best of our knowledge, the present study is the first reported analysis of the risk factors for pseudoarthrosis using a large inpatient data sample of patients who had undergone spinal fusion procedures. As with all such “big data” analyses, this method has some unique strengths and weaknesses. The greatest strength is the very large sample size—more than one-quarter million patients in several states—in our series.7, 10 Correlations can be established between variables with remarkable

Conclusions

Study of the SIDs provided by the HCUP allows investigators to easily determine the prevalence of disease states and associations between conditions and patient factors. In the present study, several risk factors for pseudoarthrosis in patients undergoing cervical, thoracic, and lumbar fusions were identified. The anterior approach, number of vertebrae fused, sleep apnea, hypertension, smoking, rheumatoid arthritis, long-term steroid use, and white race were associated with an increased risk of

Acknowledgments

We thank the One:MAP laboratory at Loyola University School of Medicine.

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Predictive factors of symptomatic lumbar pseudoarthrosis following multilevel primary lumbar fusion
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Lumbar spinal fusion surgery is a well-established treatment for various spinal disorders. However, one of its complications, pseudoarthrosis, poses a significant concern. This study aims to explore the incidence, time and predictive factors contributing to pseudoarthrosis in patients who have undergone lumbar fusion surgery over a 10-year period.
Data for this research was sourced from the PearlDiver database where insurance claims of patients who underwent multilevel lumbar spinal fusion between 01/01/2010 and 10/31/2022 were examined for claims of pseudoarthrosis within the 10 years of their index procedure. A variety of demographic, comorbid, and surgical factors were assessed, including age, gender, Elixhauser Comorbidity Index (ECI), surgical approach, substance use disorders and history of spinal disorders. Statistical analyses, including chi-squared tests, multivariate analysis, and cox survival analysis were employed to determine significant associations.
Among the 76,337 patients included in this retrospective study, 2.70% were diagnosed with symptomatic lumbar pseudoarthrosis at an average of 7.38 years in a 10-year follow-up. Multivariate and Cox hazard analyses revealed that significant predictors of symptomatic pseudoarthrosis development following multilevel primary lumbar fusion include vitamin D deficiency, osteoarthritis, opioid and NSAID use, tobacco use, and a prior history of congenital spine disorders.
In summary, this study revealed a 2.70% incidence of symptomatic lumbar pseudoarthrosis within 10 years of the index procedure. It highlighted several potential predictive factors, including comorbidities, surgical approaches, and substance use disorders, associated with the development of symptomatic pseudoarthrosis. Future research should focus on refining our understanding of these factors to improve patient outcomes and optimize healthcare resource allocation.
Letter to the editor regarding “Surgical site infection a major risk factor of pseudarthrosis in adult spinal deformity surgery” by Boishardy et al.
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Citation Excerpt :
Most factors that were no longer significant had an aHR in the same direction, but not all in the case of 6-level to 11-level posterior instrumentation (no patients had pseudarthrosis; Table 2); and a single factor became significant, diabetes (0.68; 95% CI, 0.48,0.97). The aHR and 95% CI for diabetes in the main analysis showed a nonsignificant lower risk (aHR, 0.84; 95% CI, 0.69–1.01) for pseudarthrosis and this is a consistent finding to Hofler et al.’s study,7 which also identified a nonsignificant lower risk of pseudarthrosis for patients with type 2 diabetic cervical fusion in unadjusted multivariable regression (OR, 0.87; 95% CI, 0.73–1.02). The potentially lower pseudarthrosis risk may be because patients with diabetes prioritize treatment of other medical conditions related to their diabetes, which prevents them from returning for pseudarthrosis diagnosis/treatment.
Cervical pseudarthrosis is a postoperative adverse event that occurs when a surgically induced fusion fails to establish bone growth connecting the 2 regions. It has both clinical and financial implications and may result in significant patient morbidity; it continues to be one of the leading causes of pain after surgery.
A retrospective longitudinal cohort study was performed. Patients in the IBM MarketScan Commercial Claims and Encounters (CCAE) database, 18–64 years old, who underwent elective cervical fusions during 2015–2019 were included. Patients with trauma, infection, or neoplasm were excluded. Patients were followed for 2 years from surgical fusion for occurrence of pseudarthrosis. After pseudarthrosis, subsequent surgery was documented, and cumulative incidence curves, adjusted for patient/procedure characteristics, with 95% confidence intervals (CIs) were generated. Risk factors were evaluated with multivariable Cox regression analysis.
The cohort included 45,584 patients. The 1-year and 2-year incidence of pseudarthrosis was 2.0% (95% CI, 1.9%–2.2%) and 3.3% (95% CI, 3.1%–3.5%), respectively. Factors significantly associated with increased risk of pseudarthrosis were female gender, current/previous substance abuse, previous spinal pain in the cervical/thoracic/lumbar spine, and Elixhauser score ≥5. Factors significantly associated with decreased risk of pseudarthrosis were anterior cervical approach, use of an interbody cage, and 2-level or 3-level anterior instrumentation. The 1-year and 2-year incidence of subsequent surgery in patients with pseudarthrosis was 11.7% (95% CI, 9.6%–13.7%) and 13.8% (95% CI, 11.5%–16.2%), respectively.
Cervical pseudarthrosis and subsequent surgery still occur at a low rate. Surgical factors such as anterior approach, interbody cage use, and anterior instrumentation may reduce pseudarthrosis risk.
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Notably, 88% of pseudoarthrosis cases are associated with fusion length, osteotomy requirement, pelvic fixation and combined approach [18]. Hofler et al. [19] reported on multivariable analysis, patients with the posterior-only approach or combined approach were significantly less likely to develop pseudoarthrosis compared with patients with anterior only approach. Although in their study, the risk of pseudoarthrosis with 4–8 vertebrae fused was not significantly increased, patients with ≥9 vertebrae fused were more likely to experience pseudoarthrosis than were those only 2–3 vertebrae.
Pseudoarthrosis, often defined as a failure to achieve osseous fusion by the 1-year post-operative time point. Despite its relatively high prevalence, there is still lack of clinical evidence on salvage options for lumbar pseudoarthrosis. Lumbar interbody fusion is generally accepted as a useful surgical treatment for patients with pseudoarthrosis. Several techniques are available to achieve stabilization of the lumbar spine including the anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), transforaminal interbody fusion (TLIF), direct lateral interbody fusion, posterolateral only (intertransverse) fusion, and facet or pedicle screw/rod placement. We present a case report of discoplasty as a salvage option for pseudoarthrosis following lumbar fusion surgery using multilevel TLIFs.
This study is a case report. A female patient, 79 year old, came with recurrent backpain at the lumbar area that got worse during the past 3 months. She underwent posterior lumbar fusion surgery of L3-S1 by pedicle screw and transforaminal interbody fusion at the level of L3-S1. Three years later she experienced another episode of back pain and underwent pedicle screws removal to improve her pain. Two years later complaint reappeared. The pain was rated 7/10 in standing position and improved to 5/10 with resting in horizontal position. We followed up this patient for 1 month after surgery.
After surgery, VAS score was decreased from 7/10 into 1/10 in standing position and patient was able to stand and walk using a walker. Postoperatively plain radiograph was performed and there was no complication. In a month follow up, the VAS score was 1/10 with ODI score reduces significantly from 38% to 4% showing only minimal disability.
Salvage discoplasty for pseudoarthrosis following posterior lumbar fusion surgery is rarely reported, but it appears to be viable option aside from ALIF that results in significant improvement in clinical outcomes. Discoplasty offers a less invasive solution in elderly patients which significantly reduces the symptoms and improves the quality of life of the affected patients.
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The posterior approach to the cervical spine has been described since the early 1900s and it is still commonly used to treat various cervical pathologies. It allows for an extensile exposure of the posterior cervical spine, and when employed for the correct indications it yields good results. However, there are various complications associated with this approach that can negatively impact patient outcomes. In general, avoiding complications is best achieved with careful diagnostic assessment, good patient selection and meticulous technical execution of the surgical procedure. This article reviews some of the most common complications following posterior cervical spine procedures.
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Spine fusion surgery is commonly performed for diverse indications, the most frequent one being degenerative spine diseases. Despite the growing importance of this surgery, there is limited evidence concerning the effects of drugs on the process of spine fusion and healing. While asymptomatic sometimes, nonunion of the spine can have tremendous repercussions on the patients’ quality of life and the healthcare system rendering it an “expensive complication”. This literature review identifies the role of some perioperative drugs in spine fusion and reveals their potential role in pseudarthrosis of the spine. This review also benefits spine surgeons looking for current evidence-based practices. We reviewed the data related to nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, vancomycin, bisphosphonates, proton pump inhibitors (PPIs), pregabalin, and opioids. From the available experimental and clinical studies, we conclude that bisphosphonates might positively influence the process of spine fusion, while steroids and vancomycin have shown variable effects, and the remaining medications likely disturb healing and union of the spine. We recommend spine surgeons be cautious about the drugs they resort to in the critical perioperative period until further clinical studies prove which drugs are safe to be used.

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: Conflict of interest statement: G. A. Jones has received research support, paid directly to the institution, from Medtronic, owns stock in InVivo Therapeutics, received an honorarium from the Chicago Review Course, and has received compensation for travel expenses from the Cleveland Spine Review. The remaining authors have no disclosures to report.

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Original ArticleRisk of Pseudoarthrosis After Spinal Fusion: Analysis From the Healthcare Cost and Utilization Project

Highlights

Background

Methods

Results

Conclusions

Introduction

Section snippets

Data Source

Results

Discussion

Conclusions

Acknowledgments

Spine J

5-Year reoperation risk and causes for revision after idiopathic scoliosis surgery

Spine

Cost per quality-adjusted life year gained of revision lumbar pseudoarthrosis: defining the value of surgery

J Spinal Disord Tech

Revision lumbar surgery in elderly patients with symptomatic pseudarthrosis, adjacent-segment disease, or same-level recurrent stenosis. Part 2. A cost-effectiveness analysis: clinical article

J Neurosurg Spine

Pseudarthrosis of the cervical spine: risk factors, diagnosis, and management

Asian Spine J

The effects of smoking on perioperative outcomes and pseudarthrosis following anterior cervical corpectomy: clinical article

J Neurosurg Spine

Anterior cervical pseudarthrosis: natural history and treatment

Spine (Phila Pa 1976)

Healthcare Cost and Utilization Project (HCUP). April 2017. Agency for Healthcare Research and Quality. Rockville, MD

Hierarchical modeling using HCUP data HCUP methods series report no. 2007-01. January 10, 2007. U.S. Agency for Healthcare Research and Quality

SAS, version 9.4

The Healthcare Cost and Utilization Project: an Overview

Eff Clin Pract

Construct type and risk factors for pseudarthrosis at the cervicothoracic junction

Spine

Original Article
Risk of Pseudoarthrosis After Spinal Fusion: Analysis From the Healthcare Cost and Utilization Project