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Eric W. Sankey, Vikram A. Mehta, Timothy Y. Wang, Tracey T. Than, C. Rory Goodwin, Isaac O. Karikari, Christopher I. Shaffrey, Muhammad M. Abd-El-Barr, and Khoi D. Than

Spine surgery has been disproportionately impacted by medical liability and malpractice litigation, with the majority of claims and payouts related to procedural error. One common area for the potential avoidance of malpractice claims and subsequent payouts involves misplaced pedicle and/or lateral mass instrumentation. However, the medicolegal impact of misplaced screws on spine surgery has not been directly reported in the literature. The authors of the current study aimed to describe this impact in the United States, as well as to suggest a potential method for mitigating the problem.

This retrospective analysis of 68 closed medicolegal cases related to misplaced screws in spine surgery showed that neurosurgeons and orthopedic spine surgeons were equally named as the defendant (n = 32 and 31, respectively), and cases were most commonly due to misplaced lumbar pedicle screws (n = 41, 60.3%). Litigation resulted in average payouts of $1,204,422 ± $753,832 between 1995 and 2019, when adjusted for inflation. The median time to case closure was 56.3 (35.2–67.2) months when ruled in favor of the plaintiff (i.e., patient) compared to 61.5 (51.4–77.2) months for defendant (surgeon) verdicts (p = 0.117).

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Yoji Ogura, Jeffrey L. Gum, Alex Soroceanu, Alan H. Daniels, Breton Line, Themistocles Protopsaltis, Richard A. Hostin, Peter G. Passias, Douglas C. Burton, Justin S. Smith, Christopher I. Shaffrey, Virginie Lafage, Renaud Lafage, Eric O. Klineberg, Han Jo Kim, Andrew Harris, Khaled Kebaish, Frank Schwab, Shay Bess, Christopher P. Ames, Leah Y. Carreon, and the International Spine Study Group (ISSG)

OBJECTIVE

The shared decision-making (SDM) process provides an opportunity to answer frequently asked questions (FAQs). The authors aimed to present a concise list of answers to FAQs to aid in SDM for adult spinal deformity (ASD) surgery.

METHODS

From a prospective, multicenter ASD database, patients enrolled between 2008 and 2016 who underwent fusions of 5 or more levels with a minimum 2-year follow-up were included. All deformity types were included to provide general applicability. The authors compiled a list of FAQs from patients undergoing ASD surgery and used a retrospective analysis to provide answers. All responses are reported as either the means or the proportions reaching the minimal clinically important difference at the 2-year follow-up interval.

RESULTS

Of 689 patients with ASD who were eligible for 2-year follow-up, 521 (76%) had health-related quality-of-life scores available at the time of that follow-up. The mean age at the initial surgery was 58.2 years, and 78% of patients were female. The majority (73%) underwent surgery with a posterior-only approach. The mean number of fused levels was 12.2. Revision surgery accounted for 48% of patients. The authors answered 12 FAQs as follows:

1. Will my pain improve? Back and leg pain will both be reduced by approximately 50%.

2. Will my activity level improve? Approximately 65% of patients feel improvement in their activity level.

3. Will I feel better about myself? More than 70% of patients feel improvement in their appearance.

4. Is there a chance I will get worse? 4.1% feel worse at 2 years postoperatively.

5. What is the likelihood I will have a complication? 67.8% will have a major or minor complication, with 47.8% having a major complication.

6. Will I need another surgery? 25.0% will have a reoperation within 2 years.

7. Will I regret having surgery? 6.5% would not choose the same treatment.

8. Will I get a blood transfusion? 73.7% require a blood transfusion.

9. How long will I stay in the hospital? You need to stay 8.1 days on average.

10. Will I have to go to the ICU? 76.0% will have to go to the ICU.

11. Will I be able to return to work? More than 70% will be working at 1 year postoperatively.

12. Will I be taller after surgery? You will be 1.1 cm taller on average.

CONCLUSIONS

The above list provides concise, practical answers to FAQs encountered in the SDM process while counseling patients for ASD surgery.

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Jesse J. McClure, Bhargav D. Desai, Leah M. Shabo, Thomas J. Buell, Chun-Po Yen, Justin S. Smith, Christopher I. Shaffrey, Mark E. Shaffrey, and Avery L. Buchholz

OBJECTIVE

Anterior cervical discectomy and fusion (ACDF) is a safe and effective intervention to treat cervical spine pathology. Although these were originally performed as single-level procedures, multilevel ACDF has been performed for patients with extensive degenerative disc disease. To date, there is a paucity of data regarding outcomes related to ACDFs of 3 or more levels. The purpose of this study was to compare surgical outcomes of 3- and 4-level ACDF procedures.

METHODS

The authors performed a retrospective chart review of patients who underwent 3- and 4-level ACDF at the University of Virginia Health System between January 2010 and December 2017. In patients meeting the inclusion/exclusion criteria, demographics, fusion rates, time to fusion, and reoperation rates were evaluated. Fusion was determined by < 1 mm of change in interspinous distance between individual fused vertebrae on lateral flexion/extension radiographs and lack of radiolucency between the grafts and vertebral bodies. Any procedure requiring a surgical revision was considered a failure.

RESULTS

Sixty-six patients (47 with 3-level and 19 with 4-level ACDFs) met the inclusion/exclusion criteria of having at least one lateral flexion/extension radiograph series ≥ 12 months after surgery. Seventy percent of 3-level patients and 68% of 4-level patients had ≥ 24 months of follow-up. Ninety-four percent of 3-level patients and 100% of 4-level patients achieved radiographic fusion for at least 1 surgical level. Eighty-eight percent and 82% of 3- and 4-level patients achieved fusion at C3–4; 85% and 89% of 3- and 4-level patients achieved fusion at C4–5; 68% and 89% of 3- and 4-level patients achieved fusion at C5–6; 44% and 42% of 3- and 4-level patients achieved fusion at C6–7; and no patients achieved fusion at C7–T1. Time to fusion was not significantly different between levels. Revision was required in 6.4% of patients with 3-level and in 16% of patients with 4-level ACDF. The mean time to revision was 46.2 and 45.4 months for 3- and 4-level ACDF, respectively. The most common reason for revision was worsening of initial symptoms.

CONCLUSIONS

The authors’ experience with long-segment anterior cervical fusions shows their fusion rates exceeding most of the reported fusion rates for similar procedures in the literature, with rates similar to those reported for short-segment ACDFs. Three-level and 4-level ACDF procedures are viable options for cervical spine pathology, and the authors’ analysis demonstrates an equivalent rate of fusion and time to fusion between 3- and 4-level surgeries.

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Christine Park, Alessandra N. Garcia, Chad Cook, Christopher I. Shaffrey, and Oren N. Gottfried

OBJECTIVE

Obese body habitus is a challenging issue to address in lumbar spine surgery. There is a lack of consensus on the long-term influence of BMI on patient-reported outcomes and satisfaction. This study aimed to examine the differences in patient-reported outcomes over the course of 12 and 24 months among BMI classifications of patients who underwent lumbar surgery.

METHODS

A search was performed using the Quality Outcomes Database (QOD) Spine Registry from 2012 to 2018 to identify patients who underwent lumbar surgery and had either a 12- or 24-month follow-up. Patients were categorized based on their BMI as normal weight (≤ 25 kg/m2), overweight (25–30 kg/m2), obese (30–40 kg/m2), and morbidly obese (> 40 kg/m2). Outcomes included the Oswestry Disability Index (ODI) and the visual analog scale (VAS) for back pain (BP) and leg pain (LP), and patient satisfaction was measured at 12 and 24 months postoperatively.

RESULTS

A total of 31,765 patients were included. At both the 12- and 24-month follow-ups, those who were obese and morbidly obese had worse ODI, VAS-BP, and VAS-LP scores (all p < 0.01) and more frequently rated their satisfaction as “I am the same or worse than before treatment” (all p < 0.01) compared with those who were normal weight. Receiver operating characteristic curve analysis revealed that the BMI cutoffs for predicting worsening disability and surgery dissatisfaction were 30.1 kg/m2 and 29.9 kg/m2 for the 12- and 24-month follow-ups, respectively.

CONCLUSIONS

Higher BMI was associated with poorer patient-reported outcomes and satisfaction at both the 12- and 24-month follow-ups. BMI of 30 kg/m2 is the cutoff for predicting worse patient outcomes after lumbar surgery.

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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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Justin S. Smith, Thomas J. Buell, Christopher I. Shaffrey, Han Jo Kim, Eric Klineberg, Themistocles Protopsaltis, Peter Passias, Gregory M. Mundis Jr., Robert Eastlack, Vedat Deviren, Michael P. Kelly, Alan H. Daniels, Jeffrey L. Gum, Alex Soroceanu, Munish Gupta, Doug Burton, Richard Hostin, Robert Hart, Virginie Lafage, Renaud Lafage, Frank J. Schwab, Shay Bess, and Christopher P. Ames

OBJECTIVE

Although surgical treatment can provide significant improvement of symptomatic adult cervical spine deformity (ACSD), few reports have focused on the associated complications. The objective of this study was to assess complication rates at a minimum 1-year follow-up based on a prospective multicenter series of ACSD patients treated surgically.

METHODS

A prospective multicenter database of consecutive operative ACSD patients was reviewed for perioperative (< 30 days), early (30–90 days), and delayed (> 90 days) complications with a minimum 1-year follow-up. Enrollment required at least 1 of the following: cervical kyphosis > 10°, cervical scoliosis > 10°, C2–7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°.

RESULTS

Of 167 patients, 133 (80%, mean age 62 years, 62% women) had a minimum 1-year follow-up (mean 1.8 years). The most common diagnoses were degenerative (45%) and iatrogenic (17%) kyphosis. Almost 40% of patients were active or past smokers, 17% had osteoporosis, and 84% had at least 1 comorbidity. The mean baseline Neck Disability Index and modified Japanese Orthopaedic Association scores were 47 and 13.6, respectively. Surgical approaches were anterior-only (18%), posterior-only (47%), and combined (35%). A total of 132 complications were reported (54 minor and 78 major), and 74 (56%) patients had at least 1 complication. The most common complications included dysphagia (11%), distal junctional kyphosis (9%), respiratory failure (6%), deep wound infection (6%), new nerve root motor deficit (5%), and new sensory deficit (5%). A total of 4 deaths occurred that were potentially related to surgery, 2 prior to 1-year follow-up (1 cardiopulmonary and 1 due to obstructive sleep apnea and narcotic use) and 2 beyond 1-year follow-up (both cardiopulmonary and associated with revision procedures). Twenty-six reoperations were performed in 23 (17%) patients, with the most common indications of deep wound infection (n = 8), DJK (n = 7), and neurological deficit (n = 6). Although anterior-only procedures had a trend toward lower overall (42%) and major (21%) complications, rates were not significantly different from posterior-only (57% and 33%, respectively) or combined (61% and 37%, respectively) approaches (p = 0.29 and p = 0.38, respectively).

CONCLUSIONS

This report provides benchmark rates for ACSD surgery complications at a minimum 1-year (mean 1.8 years) follow-up. The marked health and functional impact of ACSD, the frail population it affects, and the high rates of surgical complications necessitate a careful risk-benefit assessment when contemplating surgery. Collectively, these findings provide benchmarks for complication rates and may prove useful for patient counseling and efforts to improve the safety of care.

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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).