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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).

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Thomas J. Buell, Ulas Yener, Tony R. Wang, Avery L. Buchholz, Chun-Po Yen, Mark E. Shaffrey, Christopher I. Shaffrey and Justin S. Smith

OBJECTIVE

Sacral insufficiency fracture after lumbosacral (LS) arthrodesis is an uncommon complication. The objective of this study was to report the authors’ operative experience managing this complication, review pertinent literature, and propose a treatment algorithm.

METHODS

The authors analyzed consecutive adult patients treated at their institution from 2009 to 2018. Patients who underwent surgery for sacral insufficiency fractures after posterior instrumented LS arthrodesis were included. PubMed was queried to identify relevant articles detailing management of this complication.

RESULTS

Nine patients with a minimum 6-month follow-up were included (mean age 73 ± 6 years, BMI 30 ± 6 kg/m2, 56% women, mean follow-up 35 months, range 8–96 months). Six patients had osteopenia/osteoporosis (mean dual energy x-ray absorptiometry hip T-score −1.6 ± 0.5) and 3 received treatment. Index LS arthrodesis was performed for spinal stenosis (n = 6), proximal junctional kyphosis (n = 2), degenerative scoliosis (n = 1), and high-grade spondylolisthesis (n = 1). Presenting symptoms of back/leg pain (n = 9) or lower extremity weakness (n = 3) most commonly occurred within 4 weeks of index LS arthrodesis, which prompted CT for fracture diagnosis at a mean of 6 weeks postoperatively. All sacral fractures were adjacent or involved S1 screws and traversed the spinal canal (Denis zone III). H-, U-, or T-type sacral fracture morphology was identified in 7 patients. Most fractures (n = 8) were Roy-Camille type II (anterior displacement with kyphosis). All patients underwent lumbopelvic fixation via a posterior-only approach; mean operative duration and blood loss were 3.3 hours and 850 ml, respectively. Bilateral dual iliac screws were utilized in 8 patients. Back/leg pain and weakness improved postoperatively. Mean sacral fracture anterolisthesis and kyphotic angulation improved (from 8 mm/11° to 4 mm/5°, respectively) and all fractures were healed on radiographic follow-up (mean duration 29 months, range 8–90 months). Two patients underwent revision for rod fractures at 1 and 2 years postoperatively. A literature review found 17 studies describing 87 cases; potential risk factors were osteoporosis, longer fusions, high pelvic incidence (PI), and postoperative PI-to–lumbar lordosis (LL) mismatch.

CONCLUSIONS

A high index of suspicion is needed to diagnose sacral insufficiency fracture after LS arthrodesis. A trial of conservative management is reasonable for select patients; potential surgical indications include refractory pain, neurological deficit, fracture nonunion with anterolisthesis or kyphotic angulation, L5–S1 pseudarthrosis, and spinopelvic malalignment. Lumbopelvic fixation with iliac screws may be effective salvage treatment to allow fracture healing and symptom improvement. High-risk patients may benefit from prophylactic lumbopelvic fixation at the time of index LS arthrodesis.

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Elizabeth L. Yanik, Michael P. Kelly, Jon D. Lurie, Christine R. Baldus, Christopher I. Shaffrey, Frank J. Schwab, Shay Bess, Lawrence G. Lenke, Adam LaBore and Keith H. Bridwell

OBJECTIVE

Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.

METHODS

Patients 40–80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7).

RESULTS

Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence−lumbar lordosis (PI–LL) match (≤ 11°). Male patients and patients with more (> 11°) PI–LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes.

CONCLUSIONS

Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI–LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.

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Steven N. Kalkanis, Christopher I. Shaffrey, Ganesh Rao, Shelly D. Timmons, Brian L. Hoh and John A. Wilson