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Jay K. Nathan, Mitchell A. Johnson, Jennifer F. Waljee, Nicholas Szerlip, Paul Park and Mark E. Oppenlander

OBJECTIVE

Approximately 550,000 Americans experience vertebral fracture annually, and most receive opioids to treat the resulting pain. Kyphoplasty of the fractured vertebra is a procedural alternative that may mitigate risks of even short-term opioid use. While reports of kyphoplasty’s impact on pain scores are mixed, no large-scale data exist regarding opioid prescribing before and after the procedure. This study was conducted to determine whether timing of kyphoplasty following vertebral fracture is associated with duration or intensity of opioid prescribing.

METHODS

This retrospective cohort study used 2001–2014 insurance claims data from a single, large private insurer in the US across multiple care settings. Patients were adults with vertebral fractures who were prescribed opioids and underwent balloon-assisted kyphoplasty within 4 months of fracture. Opioid overdose risk was stratified by prescribed average daily morphine milligram equivalents using CDC guidelines. Filled prescriptions and risk categories were evaluated at baseline and 90 days following kyphoplasty.

RESULTS

Inclusion criteria were met by 7119 patients (median age 77 years, 71.7% female). Among included patients, 3505 (49.2%) were opioid naïve before fracture. Of these patients, 31.1% had new persistent opioid prescribing beyond 90 days after kyphoplasty, and multivariable logistic regression identified kyphoplasty after 8 weeks as a predictor (OR 1.34, 95% CI 1.02–1.76). For patients previously receiving opioids, kyphoplasty > 4 weeks after fracture was associated with persistently elevated prescribing risk (OR 1.84, 95% CI 1.23–2.74).

CONCLUSIONS

New persistent opioid prescribing occurred in nearly one-third of patients undergoing kyphoplasty after vertebral fracture, although early treatment was associated with a reduction in this risk. For patients not naïve to opioids before fracture diagnosis, early kyphoplasty was associated with less persistent elevation of opioid overdose risk. Subsequent trials must compare opioid use by vertebral fracture patients treated via operative (kyphoplasty) and nonoperative (ongoing opioid) strategies before concluding that kyphoplasty lacks value, and early referral for kyphoplasty may be appropriate to avoid missing a window of efficacy.

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Suyash Singh, Jayesh Sardhara, Anant Mehrotra and Sanjay Behari

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Paul Park, Khoi D. Than, Praveen V. Mummaneni, Pierce D. Nunley, Robert K. Eastlack, Juan S. Uribe, Michael Y. Wang, Vivian Le, Richard G. Fessler, David O. Okonkwo, Adam S. Kanter, Neel Anand, Dean Chou, Kai-Ming G. Fu, Alexander F. Haddad, Christopher I. Shaffrey, Gregory M. Mundis Jr. and the International Spine Study Group

OBJECTIVE

Surgical decision-making and planning is a key factor in optimizing outcomes in adult spinal deformity (ASD). Minimally invasive spinal (MIS) strategies for ASD have been increasingly used as an option to decrease postoperative morbidity. This study analyzes factors involved in the selection of either a traditional open approach or a minimally invasive approach to treat ASD in a prospective, nonrandomized multicenter trial. All centers had at least 5 years of experience in minimally invasive techniques for ASD.

METHODS

The study enrolled 268 patients, of whom 120 underwent open surgery and 148 underwent MIS surgery. Inclusion criteria included age ≥ 18 years, and at least one of the following criteria: coronal curve (CC) ≥ 20°, sagittal vertical axis (SVA) > 5 cm, pelvic tilt (PT) > 25°, or thoracic kyphosis (TK) > 60°. Surgical approach selection was made at the discretion of the operating surgeon. Preoperative significant differences were included in a multivariate logistic regression analysis to determine odds ratios (ORs) for approach selection.

RESULTS

Significant preoperative differences (p < 0.05) between open and MIS groups were noted for age (61.9 vs 66.7 years), numerical rating scale (NRS) back pain score (7.8 vs 7), CC (36° vs 26.1°), PT (26.4° vs 23°), T1 pelvic angle (TPA; 25.8° vs 21.7°), and pelvic incidence–lumbar lordosis (PI-LL; 19.6° vs 14.9°). No significant differences in BMI (29 vs 28.5 kg/m2), NRS leg pain score (5.2 vs 5.7), Oswestry Disability Index (48.4 vs 47.2), Scoliosis Research Society 22-item questionnaire score (2.7 vs 2.8), PI (58.3° vs 57.1°), LL (38.9° vs 42.3°), or SVA (73.8 mm vs 60.3 mm) were found. Multivariate analysis found that age (OR 1.05, p = 0.002), VAS back pain score (OR 1.21, p = 0.016), CC (OR 1.03, p < 0.001), decompression (OR 4.35, p < 0.001), and TPA (OR 1.09, p = 0.023) were significant factors in approach selection.

CONCLUSIONS

Increasing age was the primary driver for selecting MIS surgery. Conversely, increasingly severe deformities and the need for open decompression were the main factors influencing the selection of traditional open surgery. As experience with MIS surgery continues to accumulate, future longitudinal evaluation will reveal if more experience, use of specialized treatment algorithms, refinement of techniques, and technology will expand surgeon adoption of MIS techniques for adult spinal deformity.

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Erica F. Bisson, Praveen V. Mummaneni, Michael S. Virk, John Knightly, Mohammed Ali Alvi, Anshit Goyal, Andrew K. Chan, Jian Guan, Steven Glassman, Kevin Foley, Jonathan R. Slotkin, Eric A. Potts, Mark E. Shaffrey, Christopher I. Shaffrey, Regis W. Haid Jr., Kai-Ming Fu, Michael Y. Wang, Paul Park, Anthony L. Asher and Mohamad Bydon

OBJECTIVE

Lumbar decompression without arthrodesis remains a potential treatment option for cases of low-grade spondylolisthesis (i.e., Meyerding grade I). Minimally invasive surgery (MIS) techniques have recently been increasingly used because of their touted benefits including lower operating time, blood loss, and length of stay. Herein, the authors analyzed patients enrolled in a national surgical registry and compared the baseline characteristics and postoperative clinical and patient-reported outcomes (PROs) between patients undergoing open versus MIS lumbar decompression.

METHODS

The authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis undergoing a surgical intervention between July 2014 and June 2016. Among more than 200 participating sites, the 12 with the highest enrollment of patients into the lumbar spine module came together to initiate a focused project to assess the impact of fusion on PROs in patients undergoing surgery for grade I lumbar spondylolisthesis. For the current study, only patients in this cohort from the 12 highest-enrolling sites who underwent a decompression alone were evaluated and classified as open or MIS (tubular decompression). Outcomes of interest included PROs at 2 years; perioperative outcomes such as blood loss and complications; and postoperative outcomes such as length of stay, discharge disposition, and reoperations.

RESULTS

A total of 140 patients undergoing decompression were selected, of whom 71 (50.7%) underwent MIS and 69 (49.3%) underwent an open decompression. On univariate analysis, the authors observed no significant differences between the 2 groups in terms of PROs at 2-year follow-up, including back pain, leg pain, Oswestry Disability Index score, EQ-5D score, and patient satisfaction. On multivariable analysis, compared to MIS, open decompression was associated with higher satisfaction (OR 7.5, 95% CI 2.41–23.2, p = 0.0005). Patients undergoing MIS decompression had a significantly shorter length of stay compared to the open group (0.68 days [SD 1.18] vs 1.83 days [SD 1.618], p < 0.001).

CONCLUSIONS

In this multiinstitutional prospective study, the authors found comparable PROs as well as clinical outcomes at 2 years between groups of patients undergoing open or MIS decompression for low-grade spondylolisthesis.

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Anthony M. DiGiorgio, Praveen V. Mummaneni, Paul Park, Andrew K. Chan, Erica F. Bisson, Mohamad Bydon, Kevin T. Foley, Steven D. Glassman, Christopher I. Shaffrey, Eric A. Potts, Mark E. Shaffrey, Domagoj Coric, John J. Knightly, Michael Y. Wang, Kai-Ming Fu, Anthony L. Asher, Michael S. Virk, Panagiotis Kerezoudis, Mohammed Ali Alvi, Jian Guan, Regis W. Haid Jr. and Jonathan R. Slotkin

OBJECTIVE

Return to work (RTW) and satisfaction are important outcome measures after surgery for degenerative spine disease. The authors queried the prospective Quality Outcomes Database (QOD) to determine if RTW correlated with patient satisfaction.

METHODS

The QOD was queried for patients undergoing surgery for degenerative lumbar spondylolisthesis. The primary outcome of interest was correlation between RTW and patient satisfaction, as measured by the North American Spine Society patient satisfaction index (NASS). Secondarily, data on satisfied patients were analyzed to see what patient factors correlated with RTW.

RESULTS

Of 608 total patients in the QOD spondylolisthesis data set, there were 292 patients for whom data were available on both satisfaction and RTW status. Of these, 249 (85.3%) were satisfied with surgery (NASS score 1–2), and 224 (76.7%) did RTW after surgery. Of the 68 patients who did not RTW after surgery, 49 (72.1%) were still satisfied with surgery. Of the 224 patients who did RTW, 24 (10.7%) were unsatisfied with surgery (NASS score 3–4). There were significantly more people who had an NASS score of 1 in the RTW group than in the non-RTW group (71.4% vs 42.6%, p < 0.05). Failure to RTW was associated with lower level of education, worse baseline back pain (measured with a numeric rating scale), and worse baseline disability (measured with the Oswestry Disability Index [ODI]).

CONCLUSIONS

There are a substantial number of patients who are satisfied with surgery even though they did not RTW. Patients who were satisfied with surgery and did not RTW typically had worse preoperative back pain and ODI and typically did not have a college education. While RTW remains an important measure after surgery, physicians should be mindful that patients who do not RTW may still be satisfied with their outcome.

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Anthony L. Asher, John Knightly, Praveen V. Mummaneni, Mohammed Ali Alvi, Matthew J. McGirt, Yagiz U. Yolcu, Andrew K. Chan, Steven D. Glassman, Kevin T. Foley, Jonathan R. Slotkin, Eric A. Potts, Mark E. Shaffrey, Christopher I. Shaffrey, Regis W. Haid Jr., Kai-Ming Fu, Michael Y. Wang, Paul Park, Erica F. Bisson, Robert E. Harbaugh and Mohamad Bydon

The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality Outcomes Database (N2QOD), was established by the NeuroPoint Alliance (NPA) in collaboration with relevant national stakeholders and experts. The overarching goal of this project was to develop a centralized, nationally coordinated effort to allow individual surgeons and practice groups to collect, measure, and analyze practice patterns and neurosurgical outcomes. Specific objectives of this registry program were as follows: “1) to establish risk-adjusted national benchmarks for both the safety and effectiveness of neurosurgical procedures, 2) to allow practice groups and hospitals to analyze their individual morbidity and clinical outcomes in real time, 3) to generate both quality and efficiency data to support claims made to public and private payers and objectively demonstrate the value of care to other stakeholders, 4) to demonstrate the comparative effectiveness of neurosurgical and spine procedures, 5) to develop sophisticated ‘risk models’ to determine which subpopulations of patients are most likely to benefit from specific surgical interventions, and 6) to facilitate essential multicenter trials and other cooperative clinical studies.” The NPA has launched several neurosurgical specialty modules in the QOD program in the 7 years since its inception including lumbar spine, cervical spine, and spinal deformity and cerebrovascular and intracranial tumor. The QOD Spine modules, which are the primary subject of this paper, have evolved into the largest North American spine registries yet created and have resulted in unprecedented cooperative activities within our specialty and among affiliated spine care practitioners. Herein, the authors discuss the experience of QOD Spine programs to date, with a brief description of their inception, some of the key achievements and milestones, as well as the recent transition of the spine modules to the American Spine Registry (ASR), a collaboration between the American Association of Neurological Surgeons and the American Academy of Orthopaedic Surgeons (AAOS).

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Zoher Ghogawala, Shekar Kurpad, Asdrubal Falavigna, Michael W. Groff, Daniel M. Sciubba, Jau-Ching Wu, Paul Park, Sigurd Berven, Daniel J. Hoh, Erica F. Bisson, Michael P. Steinmetz, Marjorie C. Wang, Dean Chou, Charles A. Sansur, Justin S. Smith and Luis M. Tumialán

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Erica F. Bisson, Praveen V. Mummaneni, John Knightly, Mohammed Ali Alvi, Anshit Goyal, Andrew K. Chan, Jian Guan, Michael Biase, Andrea Strauss, Steven Glassman, Kevin Foley, Jonathan R. Slotkin, Eric Potts, Mark Shaffrey, Christopher I. Shaffrey, Regis W. Haid Jr., Kai-Ming Fu, Michael Y. Wang, Paul Park, Anthony L. Asher and Mohamad Bydon

OBJECTIVE

Loss to follow-up has been shown to bias outcomes assessment among studies utilizing clinical registries. Here, the authors analyzed patients enrolled in a national surgical registry and compared the baseline characteristics of patients captured with those lost to follow-up at 2 years.

METHODS

The authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis undergoing a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multisite study investigating the impact of fusion on clinical and patient-reported outcomes (PROs) among patients with grade I spondylolisthesis were evaluated.

RESULTS

Of the 608 patients enrolled in the study undergoing 1- or 2-level decompression (23.0%, n = 140) or 1-level fusion (77.0%, n = 468), 14.5% (n = 88) were lost to follow-up at 2 years. Patients who were lost to follow-up were more likely to be younger (59.6 ± 13.5 vs 62.6 ± 11.7 years, p = 0.031), be employed (unemployment rate: 53.3% [n = 277] for successful follow-up vs 40.9% [n = 36] for those lost to follow-up, p = 0.017), have anxiety (26.1% [n = 23] vs 16.3% [n = 85], p = 0.026), have higher back pain scores (7.4 ± 2.9 vs 6.6 ± 2.8, p = 0.010), have higher leg pain scores (7.4 ± 2.5 vs 6.4 ± 2.9, p = 0.003), have higher Oswestry Disability Index scores (50.8 ± 18.7 vs 46 ± 16.8, p = 0.018), and have lower EQ-5D scores (0.481 ± 0.2 vs 0.547 ± 0.2, p = 0.012) at baseline.

CONCLUSIONS

To execute future, high-quality studies, it is important to identify patients undergoing surgery for spondylolisthesis who might be lost to follow-up. In a large, prospective registry, the authors found that those lost to follow-up were more likely to be younger, be employed, have anxiety disorder, and have worse PRO scores.

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Mohamed Macki, Mohammed Ali Alvi, Panagiotis Kerezoudis, Shujie Xiao, Lonni Schultz, Michael Bazydlo, Mohamad Bydon, Paul Park, Victor Chang and for the MSSIC Investigators

OBJECTIVE

As compensation transitions from a fee-for-service to pay-for-performance healthcare model, providers must prioritize patient-centered experiences. Here, the authors’ primary aim was to identify predictors of patient dissatisfaction at 1 and 2 years after lumbar surgery.

METHODS

The Michigan Spine Surgery Improvement Collaborative (MSSIC) was queried for all lumbar operations at the 1- and 2-year follow-ups. Predictors of patients’ postoperative contentment were identified per the North American Spine Surgery (NASS) Patient Satisfaction Index, wherein satisfied patients were assigned a score of 1 (“the treatment met my expectations”) or 2 (“I did not improve as much as I had hoped, but I would undergo the same treatment for the same outcome”) and unsatisfied patients were assigned a score of 3 (“I did not improve as much as I had hoped, and I would not undergo the same treatment for the same outcome”) or 4 (“I am the same or worse than before treatment”). Multivariable Poisson generalized estimating equation models were used to report adjusted risk ratios (RRadj).

RESULTS

Among 5390 patients with a 1-year follow-up, 22% reported dissatisfaction postoperatively. Dissatisfaction was predicted by higher body mass index (RRadj =1.07, p < 0.001), African American race compared to white (RRadj = 1.51, p < 0.001), education level less than high school graduation compared to a high school diploma or equivalent (RRadj = 1.25, p = 0.008), smoking (RRadj = 1.34, p < 0.001), daily preoperative opioid use > 6 months (RRadj = 1.22, p < 0.001), depression (RRadj = 1.31, p < 0.001), symptom duration > 1 year (RRadj = 1.32, p < 0.001), previous spine surgery (RRadj = 1.32, p < 0.001), and higher baseline numeric rating scale (NRS)–back pain score (RRadj = 1.04, p = 0.002). Conversely, an education level higher than high school graduation, independent ambulation (RRadj = 0.90, p = 0.039), higher baseline NRS–leg pain score (RRadj = 0.97, p = 0.013), and fusion surgery (RRadj = 0.88, p = 0.014) decreased dissatisfaction.

Among 2776 patients with a 2-year follow-up, 22% reported dissatisfaction postoperatively. Dissatisfaction was predicted by a non-white race, current smoking (RRadj = 1.26, p = 0.004), depression (RRadj = 1.34, p < 0.001), symptom duration > 1 year (RRadj = 1.47, p < 0.001), previous spine surgery (RRadj = 1.28, p < 0.001), and higher baseline NRS–back pain score (RRadj = 1.06, p = 0.003). Conversely, at least some college education (RRadj = 0.87, p = 0.035) decreased the risk of dissatisfaction.

CONCLUSIONS

Both comorbid conditions and socioeconomic circumstances must be considered in counseling patients on postoperative expectations. After race, symptom duration was the strongest predictor of dissatisfaction; thus, patient-centered measures must be prioritized. These findings should serve as a tool for surgeons to identify at-risk populations that may need more attention regarding effective communication and additional preoperative counseling to address potential barriers unique to their situation.

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Samantha R. Horn, Peter G. Passias, Cheongeun Oh, Virginie Lafage, Renaud Lafage, Justin S. Smith, Breton Line, Neel Anand, Frank A. Segreto, Cole A. Bortz, Justin K. Scheer, Robert K. Eastlack, Vedat Deviren, Praveen V. Mummaneni, Alan H. Daniels, Paul Park, Pierce D. Nunley, Han Jo Kim, Eric O. Klineberg, Douglas C. Burton, Robert A. Hart, Frank J. Schwab, Shay Bess, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Cervical deformity (CD) correction is clinically challenging. There is a high risk of developing complications with these highly complex procedures. The aim of this study was to use baseline demographic, clinical, and surgical factors to predict a poor outcome following CD surgery.

METHODS

The authors performed a retrospective review of a multicenter prospective CD database. CD was defined as at least one of the following: cervical kyphosis (C2–7 Cobb angle > 10°), cervical scoliosis (coronal Cobb angle > 10°), C2–7 sagittal vertical axis (cSVA) > 4 cm, or chin-brow vertical angle (CBVA) > 25°. Patients were categorized based on having an overall poor outcome or not. Health-related quality of life measures consisted of Neck Disability Index (NDI), EQ-5D, and modified Japanese Orthopaedic Association (mJOA) scale scores. A poor outcome was defined as having all 3 of the following categories met: 1) radiographic poor outcome: deterioration or severe radiographic malalignment 1 year postoperatively for cSVA or T1 slope–cervical lordosis mismatch (TS-CL); 2) clinical poor outcome: failing to meet the minimum clinically important difference (MCID) for NDI or having a severe mJOA Ames modifier; and 3) complications/reoperation poor outcome: major complication, death, or reoperation for a complication other than infection. Univariate logistic regression followed by multivariate regression models was performed, and internal validation was performed by calculating the area under the curve (AUC).

RESULTS

In total, 89 patients with CD were included (mean age 61.9 years, female sex 65.2%, BMI 29.2 kg/m2). By 1 year postoperatively, 18 (20.2%) patients were characterized as having an overall poor outcome. For radiographic poor outcomes, patients’ conditions either deteriorated or remained severe for TS-CL (73% of patients), cSVA (8%), horizontal gaze (34%), and global SVA (28%). For clinical poor outcomes, 80% and 60% of patients did not reach MCID for EQ-5D and NDI, respectively, and 24% of patients had severe symptoms (mJOA score 0–11). For the complications/reoperation poor outcome, 28 patients experienced a major complication, 11 underwent a reoperation, and 1 had a complication-related death. Of patients with a poor clinical outcome, 75% had a poor radiographic outcome; 35% of poor radiographic and 37% of poor clinical outcome patients had a major complication. A poor outcome was predicted by the following combination of factors: osteoporosis, baseline neurological status, use of a transition rod, number of posterior decompressions, baseline pelvic tilt, T2–12 kyphosis, TS-CL, C2–T3 SVA, C2–T1 pelvic angle (C2 slope), global SVA, and number of levels in maximum thoracic kyphosis. The final model predicting a poor outcome (AUC 86%) included the following: osteoporosis (OR 5.9, 95% CI 0.9–39), worse baseline neurological status (OR 11.4, 95% CI 1.8–70.8), baseline pelvic tilt > 20° (OR 0.92, 95% CI 0.85–0.98), > 9 levels in maximum thoracic kyphosis (OR 2.01, 95% CI 1.1–4.1), preoperative C2–T3 SVA > 5.4 cm (OR 1.01, 95% CI 0.9–1.1), and global SVA > 4 cm (OR 3.2, 95% CI 0.09–10.3).

CONCLUSIONS

Of all CD patients in this study, 20.2% had a poor overall outcome, defined by deterioration in radiographic and clinical outcomes, and a major complication. Additionally, 75% of patients with a poor clinical outcome also had a poor radiographic outcome. A poor overall outcome was most strongly predicted by severe baseline neurological deficit, global SVA > 4 cm, and including more of the thoracic maximal kyphosis in the construct.