Polymethyl methacrylate augmentation and proximal junctional kyphosis in adult spinal deformity patients.

BACKGROUND: Proximal junctional kyphosis (PJK) is a complication following surgery for adult spinal deformity (ASD) possibly ameliorated by polymethyl methacrylate (PMMA) vertebroplasty of the upper instrumented vertebrae (UIV). This study quantifies PJK following surgical correction bridging the thoracolumbar junction ± PMMA vertebroplasty. METHODS: ASD patients from 2013 to 2020 were retrospectively reviewed and included with immediate postoperative radiographs and at least one follow-up radiograph. PMMA vertebroplasty at the UIV and UIV + 1 was performed at the surgeons' discretion. RESULTS: Of 102 patients, 56% received PMMA. PMMA patients were older (70 ± 8 vs. 66 ± 10, p = 0.021), more often female (89.3% vs. 68.2%, p = 0.005), and had more osteoporosis (26.8% vs. 9.1%, p = 0.013). 55.4% of PMMA patients developed PJK compared to 38.6% of controls (p = 0.097), and the rate of PJK development was not different between groups in univariate survival models. There was no difference in PJF (p > 0.084). Reoperation rates were 7.1% in PMMA versus 11.4% in controls (p = 0.501). In multivariable models, PJK development was not associated with the use of PMMA vertebroplasty (HR 0.77, 95% CI 0.38-1.60, p = 0.470), either when considered overall in the cohort or specifically in those with poor bone quality. PJK was significantly predicted by poor bone quality irrespective of PMMA use (HR 3.81, p < 0.001). CONCLUSIONS: In thoracolumbar fusions for adult spinal deformity, PMMA vertebroplasty was not associated with reduced PJK development, which was most highly associated with poor bone quality. Preoperative screening and management for osteoporosis is critical in achieving an optimal outcome for these complex operations. LEVEL OF EVIDENCE: 4, retrospective non-randomized case review.

A framework to make PROMs relevant to patients: qualitative study of communication preferences of PROMs.

PURPOSE: Patient-reported outcome measures are tools for evaluating symptoms, magnitude of limitations, baseline health status, and outcomes from the patient's perspective. Healthcare professional organizations and payers increasingly recommend PROMs for clinical care, but there lacks guidance regarding effective communication of PROMs with orthopedic surgery patients. This qualitative study aimed to identify (1) patient attitudes toward the use and communication of PROMs, and (2) what patients feel are the most relevant or important aspects of PROM results to discuss with their physicians. METHODS: Participants were recruited from a multispeciality orthopedic clinic. Three PROMs: the EuroQol-5 Dimension, the Patient-Specific Functional Scale, and the Patient-Reported Outcome Measurement Information System Physical Function Computer Adaptive Test were shown and a semi-structured interview was conducted to elicit PROMs attitudes and preferences. Interviews were transcribed and inductive-deductively coded. Coded excerpts were aggregated to (1) identify major themes and (2) analyze how themes interacted. RESULT: Three themes emerged: (1) Beliefs toward the purpose of PROMs, (2) PROMs as a reflection of self, and (3) PROMs to facilitate communication and guide healthcare decisions. These themes informed a framework outlining the patient perspective on communicating PROMs during clinical care. CONCLUSION: Patient attitudes toward the use and communication of PROMs start with the incorporation of patient beliefs, which can facilitate or act as a barrier to engagement. Patients should ideally believe that PROMs are an accurate reflection of personal health state before incorporation into care. Clinicians should endeavor to communicate the purpose of a chosen PROM in line with a patient's unique needs and what they feel is most relevant to their own care. Aspects of PROMs results which may be helpful to address include providing context for what scores mean and how they are calculated, and using scores as a way to weigh risks and benefits of treatment and tracking progress over time. Future research can focus on the effect of communication strategies on patient outcomes and engagement in care.

Preoperative epidural steroid injections are not associated with increased rates of infection and dural tear in lumbar spine surgery.

PURPOSE: The study objectives were to use a large national claims data resource to examine rates of preoperative epidural steroid injections (ESI) in lumbar spine surgery and determine whether preoperative ESI or the timing of preoperative ESI is associated with rates of postoperative complications and reoperations. METHODS: A retrospective longitudinal analysis of patients undergoing lumbar spine surgery for disc herniation and/or spinal stenosis was undertaken using the MarketScan® databases from 2007-2015. Propensity-score matched cohorts were constructed to compare rates of complications and reoperations in patients with and without preoperative ESI. RESULTS: Within the year prior to surgery, 120,898 (46.4%) patients had a lumber ESI. The median time between ESI and surgery was 10 weeks. 23.1% of patients having preoperative ESI had more than one level injected, and 66.5% had more than one preoperative ESI treatment. Patients with chronic pain were considerably more likely to have an ESI prior to their surgery [OR 1.62 (1.54, 1.69), p < 0.001]. Patients having preoperative ESI within in close proximity to surgery did not have increased rates of infection, dural tear, neurological complications, or surgical complications; however, they did experience higher rates of reoperations and readmissions than those with no preoperative ESI (p < 0.001). CONCLUSION: Half of patients undergoing lumbar spine surgery for stenosis and/or herniation had a preoperative ESI. These were not associated with an increased risk for postoperative complications, even when the ESI was given in close proximity to surgery. Patients with preoperative ESI were more likely to have readmissions and reoperations following surgery.

Is Uncontrolled Diabetes Mellitus Associated with Incidence of Complications After Posterior Instrumented Lumbar Fusion? A National Claims Database Analysis.

BACKGROUND: Previous research has shown that diabetes mellitus (DM) is associated with postoperative complications, including surgical site infections (SSIs). However, evidence for the association between diabetes control and postoperative complications in patients with DM is mixed. Prior studies relied on a single metric for defining uncontrolled DM, which does not account for glycemic variability, and it is unknown whether a more comprehensive assessment of diabetes control is associated with postoperative complications. QUESTIONS/PURPOSES: (1) Is there a difference in the incidence of SSI after lumbar spine fusion in patients with uncontrolled DM, defined with a comprehensive assessment of glycemic control, compared with patients with controlled DM? (2) Is there a difference in the incidence of other select postoperative complications after lumbar spine fusion in patients with uncontrolled DM compared with patients with controlled DM? (3) Is there a difference in total reimbursements between these groups? METHODS: We used the PearlDiver Patient Records Database, a national administrative claims database that provides access to the full continuum of perioperative care. We included 46,490 patients with DM undergoing posterior lumbar fusion with instrumentation. Patients were required to be continuously enrolled in the database for at least 1 year before and 90 days after the index procedure. Patients were divided into uncontrolled and controlled DM cohorts, as defined by ICD-9 diagnostic codes. These are based on a comprehensive assessment of glycemic control, including consideration of patient self-monitoring of blood glucose levels, hemoglobin A1c, and the presence/severity of diabetes-related comorbidities. The cohorts differed only by age, insurance type, and Elixhauser comorbidity score. The primary outcome was the incidence of SSI, divided into superficial and deep, within 90 days postoperatively. Secondary complications included the incidence of cerebrovascular events, acute kidney injury, pulmonary embolism, pneumonia, urinary tract infection, blood transfusion, and total reimbursements. These are the sum of reimbursements occurring within 90 days of surgery, which capture the total professional and facility cost burden to the health payer (such as the insurer). We constructed multivariable logistic regression models to adjust for the effects of age, insurance type, and comorbidities. RESULTS: After adjusting for potentially confounding variables including age, insurance type, and comorbidities, we found that patients with uncontrolled DM had an odds ratio for deep SSI of 1.52 (95% confidence interval 1.16 to 1.95; p = 0.002). Similarly, patients with uncontrolled DM had adjusted odds ratios of 1.25 (95% CI 1.01 to 1.53; p = 0.03) for cerebrovascular events, 1.36 (95% CI 1.18 to 1.57; p < 0.001) for acute kidney injury, 1.55 (95% CI 1.16 to 2.04; p = 0.002) for pulmonary embolism, 1.30 (95% CI 1.08 to 1.54; p = 0.004) for pneumonia, 1.33 (95% CI 1.19 to 1.49; p < 0.001) for urinary tract infection, and 1.27 (95% CI 1.04 to 1.53; p = 0.02) for perioperative transfusion. Patients with uncontrolled DM had higher median 90-day total reimbursements than patients with controlled DM: USD 27,915 (interquartile range 5472 to 63,400) versus USD 10,263 (IQR 4101 to 49,748; p < 0.001). CONCLUSION: Our findings encourage surgeons to take a full diabetic history beyond the HbA1c value, including any self-monitoring of glucose measurements, time in acceptable range for continuous glucose monitors, and/or consideration of the presence/severity of diabetes-related complications before lumbar spine fusion, as HbA1c does not fully capture glycemic control or variability. We emphasize that uncontrolled DM is a clinical, rather than laboratory, diagnosis. Comprehensive diabetes histories should be incorporated into existing preoperative diabetes care pathways and elective surgery could be deferred to improve glycemic control. Future development of an index measure incorporating multidimensional measures of diabetes control (such as continuous or self-glucose monitoring, diabetes-related comorbidities) is warranted. LEVEL OF EVIDENCE: Level III, therapeutic study.

The effect of anterior lumbar interbody fusion staging order on perioperative complications in circumferential lumbar fusions performed within the same hospital admission.

OBJECTIVE: Anterior lumbar interbody fusion (ALIF) is a powerful technique that provides wide access to the disc space and allows for large lordotic grafts. When used with posterior spinal fusion (PSF), the procedures are often staged within the same hospital admission. There are limited data on the perioperative risk profile of ALIF-first versus PSF-first circumferential fusions performed within the same hospital admission. In an effort to understand whether these procedures are associated with different perioperative complication profiles, the authors performed a retrospective review of their institutional experience in adult patients who had undergone circumferential lumbar fusions. METHODS: The electronic medicals records of patients who had undergone ALIF and PSF on separate days within the same hospital admission at a single academic center were retrospectively analyzed. Patients carrying a diagnosis of tumor, infection, or traumatic fracture were excluded. Demographics, surgical characteristics, and perioperative complications were collected and assessed. RESULTS: A total of 373 patients, 217 of them women (58.2%), met the inclusion criteria. The mean age of the study cohort was 60 years. Surgical indications were as follows: degenerative disease or spondylolisthesis, 171 (45.8%); adult deformity, 168 (45.0%); and pseudarthrosis, 34 (9.1%). The majority of patients underwent ALIF first (321 [86.1%]) with a mean time of 2.5 days between stages. The mean number of levels fused was 2.1 for ALIF and 6.8 for PSF. In a comparison of ALIF-first to PSF-first cases, there were no major differences in demographics or surgical characteristics. Rates of intraoperative complications including venous injury were not significantly different between the two groups. The rates of postoperative ileus (11.8% vs 5.8%, p = 0.194) and ALIF-related wound complications (9.0% vs 3.8%, p = 0.283) were slightly higher in the ALIF-first group, although the differences did not reach statistical significance. Rates of other perioperative complications were no different. CONCLUSIONS: In patients undergoing staged circumferential fusion with ALIF and PSF, there was no statistically significant difference in the rate of perioperative complications when comparing ALIF-first to PSF-first surgeries.

ISSLS PRIZE IN BASIC SCIENCE 2017: Intervertebral disc/bone marrow cross-talk with Modic changes.

STUDY DESIGN: Cross-sectional cohort analysis of patients with Modic Changes (MC). OBJECTIVE: Our goal was to characterize the molecular and cellular features of MC bone marrow and adjacent discs. We hypothesized that MC associate with biologic cross-talk between discs and bone marrow, the presence of which may have both diagnostic and therapeutic implications. BACKGROUND DATA: MC are vertebral bone marrow lesions that can be a diagnostic indicator for discogenic low back pain. Yet, the pathobiology of MC is largely unknown. METHODS: Patients with Modic type 1 or 2 changes (MC1, MC2) undergoing at least 2-level lumbar interbody fusion with one surgical level having MC and one without MC (control level). Two discs (MC, control) and two bone marrow aspirates (MC, control) were collected per patient. Marrow cellularity was analyzed using flow cytometry. Myelopoietic differentiation potential of bone marrow cells was quantified to gauge marrow function, as was the relative gene expression profiles of the marrow and disc cells. Disc/bone marrow cross-talk was assessed by comparing MC disc/bone marrow features relative to unaffected levels. RESULTS: Thirteen MC1 and eleven MC2 patients were included. We observed pro-osteoclastic changes in MC2 discs, an inflammatory dysmyelopoiesis with fibrogenic changes in MC1 and MC2 marrow, and up-regulation of neurotrophic receptors in MC1 and MC2 bone marrow and discs. CONCLUSION: Our data reveal a fibrogenic and pro-inflammatory cross-talk between MC bone marrow and adjacent discs. This provides insight into the pain generator at MC levels and informs novel therapeutic targets for treatment of MC-associated LBP.

Adult Lumbar Scoliosis: Nonsurgical Versus Surgical Management.

Adult spinal deformity has become an increasingly recognized condition, with a 32% incidence in the adult population and a 68% incidence in the elderly population. Often, patients with adult spinal deformity are initially offered nonsurgical treatment for their symptoms despite the lack of data to support its efficacy because of the high complication rate associated with surgical treatment in this age group. Determining which patients would benefit the most from nonsurgical versus surgical treatment remains a challenge. Limited evidence exists to support guidelines on the most effective way to treat patients with adult spinal deformity. Treatment decisions for patients with adult spinal deformity often rely on individual surgeon experience and patient preferences.

Long fusion from sacrum to thoracic spine for adult spinal deformity with sagittal imbalance: upper versus lower thoracic spine as site of upper instrumented vertebra.

OBJECT: Despite increasing numbers of patients with adult spinal deformity, it is unclear how to select the optimal upper instrumented vertebra (UIV) in long fusion surgery for these patients. The purpose of this study was to compare the use of vertebrae in the upper thoracic (UT) versus lower thoracic (LT) spine as the upper instrumented vertebra in long fusion surgery for adult spinal deformity. METHODS: Patients who underwent fusion from the sacrum to the thoracic spine for adult spinal deformity with sagittal imbalance at a single medical center were studied. The patients with a sagittal vertical axis (SVA) ≥ 40 mm who had radiographs and completed the 12-item Short-Form Health Survey (SF-12) preoperatively and at final follow-up (≥ 2 years postoperatively) were included. RESULTS: Eighty patients (mean age of 61.1 ± 10.9 years; 69 women and 11 men) met the inclusion criteria. There were 31 patients in the UT group and 49 patients in the LT group. The mean follow-up period was 3.6 ± 1.6 years. The physical component summary (PCS) score of the SF-12 significantly improved from the preoperative assessment to final follow-up in each group (UT, 34 to 41; LT, 29 to 37; p = 0.001). This improvement reached the minimum clinically important difference in both groups. There was no significant difference in PCS score improvement between the 2 groups (p = 0.8). The UT group had significantly greater preoperative lumbar lordosis (28° vs 18°, p = 0.03) and greater thoracic kyphosis (36° vs 18°, p = 0.001). After surgery, there was no significant difference in lumbar lordosis or thoracic kyphosis. The UT group had significantly greater postoperative cervicothoracic kyphosis (20° vs 11°, p = 0.009). The UT group tended to maintain a smaller positive SVA (51 vs 73 mm, p = 0.08) and smaller T-1 spinopelvic inclination (-2.6° vs 0.6°, p = 0.06). The LT group tended to have more proximal junctional kyphosis (PJK), although the difference did not reach statistical significance. Radiographic PJK was 32% in the UT group and 41% in the LT group (p = 0.4). Surgical PJK was 6.4% in the UT group and 10% in the LT group (p = 0.6). CONCLUSIONS: Both the UT and LT groups demonstrated significant improvement in clinical and radiographic outcomes. A significant difference was not observed in improvement of clinical outcomes between the 2 groups.

The increased prevalence of cervical spondylosis in patients with adult thoracolumbar spinal deformity.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To assess the concomitance of cervical spondylosis and thoracolumbar spinal deformity. SUMMARY OF BACKGROUND DATA: Patients with degenerative cervical spine disease have higher rates of degeneration in the lumbar spine. In addition, degenerative cervical spine changes have been observed in adult patients with thoracolumbar spinal deformities. However, to the best of our knowledge, there have been no studies quantifying the association between cervical spondylosis and thoracolumbar spinal deformity in adult patients. METHODS: Patients seen by a spine surgeon or spine specialist at a single institution were assessed for cervical spondylosis and/or thoracolumbar spinal deformity using an administrative claims database. Spinal radiographic utilization and surgical intervention were used to infer severity of spinal disease. The relative prevalence of each spinal diagnosis was assessed in patients with and without the other diagnosis. RESULTS: A total of 47,560 patients were included in this study. Cervical spondylosis occurred in 13.1% overall, but was found in 31.0% of patients with thoracolumbar spinal deformity (OR=3.27, P<0.0001). Similarly, thoracolumbar spinal deformity was found in 10.7% of patients overall, but was increased at 23.5% in patients with cervical spondylosis (OR=3.26, P<0.0001). In addition, increasing severity of disease was associated with an increased likelihood of the other spinal diagnosis. Patients with both diagnoses were more likely to undergo both cervical (OR=3.23, P<0.0001) and thoracolumbar (OR=4.14, P<0.0001) spine fusion. CONCLUSIONS: Patients with cervical spondylosis or thoracolumbar spinal deformity had significantly higher rates of the other spinal diagnosis. This correlation was increased with increased severity of disease. Patients with both diagnoses were significantly more likely to have received a spine fusion. Further research is warranted to establish the cause of this correlation. Clinicians should use this information to both screen and counsel patients who present for cervical spondylosis or thoracolumbar spinal deformity.

Timelines for Return to Different Sports Types After Eight Cervical Spine Fractures in Recreational and Elite Athletes: A Survey of the Association for Collaborative Spine Research.

STUDY DESIGN: Prospective cross-sectional survey. OBJECTIVE: To identify timelines for when athletes may be considered safe to return to varying athletic activities after sustaining cervical spine fractures. BACKGROUND: While acute management and detection of cervical spine fractures have been areas of comprehensive investigation, insight into timelines for when athletes may return to different athletic activities after sustaining such fractures is limited. METHODS: A web-based survey was administered to members of the Association for Collaborative Spine Research that consisted of surgeon demographic information and questions asking when athletes (recreational vs elite) with one of 8 cervical fractures would be allowed to return to play noncontact, contact, and collision sports treated nonoperatively or operatively. The third part queried whether the decision to return to sports was influenced by the type of fixation or the presence of radiculopathy. RESULTS: Thirty-three responses were included for analysis. For all 8 cervical spine fractures treated nonoperatively and operatively, significantly longer times to return to sports for athletes playing contact or collision sports compared with recreational and elite athletes playing noncontact sports, respectively (P< 0.05), were felt to be more appropriate. Comparing collision sports with contact sports for recreational and elite athletes, similar times for return to sports for nearly all fractures treated nonoperatively or operatively were noted. In the setting of associated radiculopathy, the most common responses for safe return to play were "when only motor deficits resolve completely" and "when both motor and sensory deficits resolve completely." CONCLUSIONS: In this survey of spine surgeons from the Association for Collaborative Spine Research, reasonable timeframes for return to play for athletes with 8 different cervical spine fractures treated nonoperatively or operatively varied based on fracture subtype and level of sporting physicality.

Patient-level patterns in daily prescribed opioid dosage in single level lumbar fusion are associated with postoperative opioid dosage and adverse events: a retrospective analysis of claims data.

BACKGROUND: Patients undergoing lumbar spine surgery have high rates of preoperative opioid use, which is associated with inferior outcomes and higher risks for opioid dependency postoperatively. PURPOSE: Determine whether there are identifiable subgroups of patients that follow distinct patterns in pre- and postoperative opioid dosing. Examine how preoperative patterns in opioid dosing relate to postoperative opioid patterns, opioid cessation, and the risk for adverse events. STUDY DESIGN/SETTING: Retrospective analysis of an administrative claims database (MeritiveTM Marketscan® Research Databases 2007-2015). PATIENT SAMPLE: The 9,768 patients undergoing primary single level lumbar fusion. OUTCOME MEASURES: Primary: daily morphine milligram equivalent (MME) opioid dosing calculated from prescriptions dispensed for 1 year before and after surgery; secondary: 90-day all-cause readmission and complications, 90-day acute postoperative pain, 90-day and 1-year reoperation, surgical costs, length of stay, and discharge disposition. METHODS: Distinct patient subgroups defined by patterns of daily MME pre- and postoperatively were identified via group-based trajectory modeling. Associations between these groups and outcomes were assessed with multivariable logistic regression with risk adjustment for patient and surgical factors. RESULTS: Among primary single level lumbar fusion patients, 59.5% filled an opioid prescription in the 3 months preceding surgery, whereas 40.5% were opioid naïve (Naïve). Five distinct subgroups of daily MME were identified among those filling opioids preoperatively: (1) Naïve to 3m (21.2% of patients): no opioids until 3 months preoperatively, escalating to 15 MME/day; (2) Low to 3m (11.4%): very low or as needed dose until 3 months preoperatively, escalating to 15 MME/day; (3) 6m Rise (6.9%): no opioids until 6 months preoperatively, escalating to >30 MME/day; (4) Medium (9.8%): increased linearly from 10 to 25 MME/day across the year before surgery; (5) High (10.0%): increased linearly from 60 to >80 MME/day across the year before surgery. These five preoperative opioid groups were related to postoperative opioids filled in a dose-response manner. The two preoperative patient groups with chronic Medium to High-dose opioid dosing were associated with increased adverse events, including all-cause readmission, reoperation, and pneumonia, whereas a low baseline group with a large, earlier preoperative rise in opioid dosing (6m Rise) had increased encounters for acute postoperative pain. Postoperatively, only 9.5% of patients did not fill an opioid prescription. Five distinct postoperative subgroups were identified based on their patterns in daily MME: Two groups ceased filling opioids within the year following surgery (33.6% of patients), and three groups declined in opioid dosage following surgery but plateaued at low (0-5 MME/day, 29.1%), medium (10-15 MME/day, 12.0%), or high (70-75 MME/day), 13.1%) doses by 1 year. Patients within the higher preoperative opioid groups were more likely to belong to the postoperative groups that were unable to cease filling opioids. CONCLUSIONS: Identification of a patient's preoperative time trend in daily opioid use may provide significant prognostic value and help guide pain management and risk reduction efforts. LEVEL OF EVIDENCE: III.

Is outpatient spine surgery associated with new, persistent opioid use in opioid-naïve patients? A retrospective national claims database analysis.

BACKGROUND CONTEXT: Although spine procedures have historically been performed inpatient, there has been a recent shift to the outpatient setting for selected cases due to increased patient satisfaction and reduced cost. Effective postoperative pain management while limiting over-prescribing of opioids, which may lead to persistent opioid use, is critical to performing spine surgery in the outpatient setting. PURPOSE: To assess if there is an increased risk for new, persistent opioid use between inpatient and outpatient spine procedures. STUDY DESIGN: Retrospective analysis using national administrative claims database. PATIENT SAMPLE: A total of 390,049 opioid-naïve patients with a perioperative opioid prescription who underwent an inpatient or outpatient spine surgery. OUTCOME MEASURES: Patients with perioperative opioid prescriptions who filled ≥ 1 opioid prescription between 90- and 180-days following surgery were defined as new, persistent opioid users. METHODS: We utilized a claims database to identify opioid-naïve patients who underwent lumbar or cervical fusion, total disc arthroplasty, or decompression procedures. We constructed a multivariable logistic regression to evaluate the association between inpatient versus outpatient surgery and the development of new, persistent opioid use while adjusting for several patient factors. RESULTS: A total of 19,205 (11.7%) inpatient and 18,546 (8.2%) outpatient patients developed new, persistent opioid use. Outpatient lumbar and cervical spine surgery patients were significantly less likely to develop new, persistent opioid use following surgery compared to inpatient spine surgery patients (OR = 0.71 [95% confidence interval {CI}: 0.69, 0.73], p < .001). Average morphine milligram equivalents (MMEs) (inpatient = 1,476 MME +/- 22.7, outpatient = 1,072 MME +/- 18.5, p < .001) and average MMEs per day (inpatient = 91.6 MME +/- 0.32, outpatient = 77.7 MME +/- 0.28, p < .001) were lower in the outpatient cohort compared to the inpatient. CONCLUSION: Our results support the shift from inpatient to outpatient spine procedures, as outpatient procedures were not associated with an increased risk for new, persistent opioid use. As more patients become candidates for outpatient spine surgery, predictors of new, persistent opioid use should be considered during risk stratification. LEVEL OF EVIDENCE: Level III Prognostic Study. MINI ABSTRACT: We utilized a national administrative claims database to identify opioid-naïve patients who underwent common spine procedures. Outpatient lumbar and cervical spine surgery patients were significantly less likely to be new, persistent opioid users following surgery compared to inpatient spine surgery patients. Our results support the shift to outpatient spine procedures.

Patient-level payment patterns prior to single level lumbar decompression are associated with resource utilization, postoperative payments, and adverse events.

BACKGROUND: Understanding patient-specific trends in costs and healthcare resource utilization (HCRU) surrounding lumbar spine surgery is critically needed to better inform surgical decision making and the development of targeted interventions. PURPOSE: 1) Identify subgroups of patients following distinct patterns in direct healthcare payments pre- and postoperatively, 2) determine whether these patterns are associated with patient and surgical factors, and 3) examine whether preoperative payment patterns are related to postoperative payments, healthcare resource utilization (HCRU), and adverse events. STUDY DESIGN/SETTING: Retrospective analysis of an administrative claims database (IBM Marketscan Research Databases 2007-2015). PATIENT SAMPLE: Adults undergoing primary single-level decompression surgery for lumbar stenosis (n=12,394). OUTCOME MEASURES: Direct healthcare payments, HCRU payments (15 categories), 90-day complications and all-cause readmission, 2-year reoperation METHODS: Group-based trajectory modeling is an application of finite mixture modeling that is able to identify meaningful subgroups within a population that follow distinct developmental trajectories over time. We used this technique to identify subgroups of patients following distinct profiles in preoperative direct healthcare payments. A separate analysis was performed to identify distinct profiles in payments postoperatively. Patient and surgical factors associated with these payment profiles were assessed with multinomial logistic regression, and associations with adverse events were assessed with risk-adjusted multivariable logistic regression. RESULTS: We identified 4 preoperative patient payment subgroups following distinct profiles in payments: Pre-Low (5.8% of patients), Pre-Early-Rising (4.8%), Pre-Medium (26.1%), and Pre-High (63.3%). Postoperatively, 3 patient subgroups were identified: Post-Low (8.9%), Post-Medium (29.6%), and Post-High (61.4%). Patients following the higher-cost pre- and postoperative payment profiles were older, more likely female, and had a greater physical and mental comorbidity burden. With each successively higher preoperative payment profile, patients were increasingly likely to have high postoperative payments, use more HCRU (particularly high-cost services such as inpatient admissions, ER, and SNF/IRF care), and experience postoperative adverse events. Following risk adjustment for patient and surgical factors, patients following the Pre-High payment profile had 209.5 (95% CI: 144.2, 309.7; p<.001) fold greater odds for following the Post-High payment profile, 1.8 (1.3, 2.5; p=.003) fold greater odds for 90-day complications, and 1.7 (1.2, 2.6; p=.035) fold greater odds for 2-year reoperation relative to patients following the Pre-Low payment profile. CONCLUSIONS: There are identifiable subgroups of patients who follow distinct profiles in direct healthcare payments surrounding lumbar decompression surgery. These payment profiles are related to patient age, sex, and physical and mental comorbidities. Notably, preoperative payment profiles may provide prognostic value, as they are associated with postoperative costs, HCRU, and adverse events. LEVEL OF EVIDENCE: III.

A Stepwise Replicable Approach to Negotiating Value-driven Supply Chain Contracts for Orthobiologics.

INTRODUCTION: Orthobiologics are increasingly used to augment healing of tissues. Despite growing demand for orthobiologic products, many health systems do not enjoy substantial savings expected with high-volume purchases. The primary goal of this study was to evaluate an institutional program designed to (1) prioritize high-value orthobiologics and (2) incentivize vendor participation in value-driven contractual programs. METHODS: A three-step approach was used to reduce costs through optimization of orthobiologics supply chain. First, surgeons with orthobiologics expertise were engaged in key supply chain purchasing decisions. Second, eight orthobiologics formulary categories were defined. Capitated pricing expectations were established for each product category. Capitated pricing expectations were established for each product using institutional invoice data and market pricing data. In comparison with similar institutions, products offered by multiple vendors were priced at a lower benchmark (10th percentile of market price) than more rare products priced at the 25th percentile of the market price. Pricing expectations were transparent to vendors. Third, a competitive bidding process required vendors to submit pricing proposals for products. Clinicians and supply chain leaders jointly awarded contracts to vendors that met pricing expectations. RESULTS: Compared with our projected estimate of $423,946 savings using capitated product prices, our actual annual savings was $542,216. Seventy-nine percent of savings came from allograft products. Although the number of total vendors decreased from 14 to 11, each of the nine returning vendors received a larger, three-year institutional contract. Average pricing decreased across seven of the eight formulary categories. DISCUSSION: This study demonstrates a three-step replicable approach to increase institutional savings for orthobiologic products, engaging clinician experts, and strengthening relationships with select vendors. Vendor consolidation permits a symbiotic win-win relationship: Health systems achieve increased value by reducing unnecessary complexity of multiple contracts, and vendors obtain larger contracts with increased market share. LEVEL OF EVIDENCE: Level IV study.

Catastrophic acute failure of pelvic fixation in adult spinal deformity requiring revision surgery: a multicenter review of incidence, failure mechanisms, and risk factors.

OBJECTIVE: There are few prior reports of acute pelvic instrumentation failure in spinal deformity surgery. The objective of this study was to determine if a previously identified mechanism and rate of pelvic fixation failure were present across multiple institutions, and to determine risk factors for these types of failures. METHODS: Thirteen academic medical centers performed a retrospective review of 18 months of consecutive adult spinal fusions extending 3 or more levels, which included new pelvic screws at the time of surgery. Acute pelvic fixation failure was defined as occurring within 6 months of the index surgery and requiring surgical revision. RESULTS: Failure occurred in 37 (5%) of 779 cases and consisted of either slippage of the rods or displacement of the set screws from the screw tulip head (17 cases), screw shaft fracture (9 cases), screw loosening (9 cases), and/or resultant kyphotic fracture of the sacrum (6 cases). Revision strategies involved new pelvic fixation and/or multiple rod constructs. Six patients (16%) who underwent revision with fewer than 4 rods to the pelvis sustained a second acute failure, but no secondary failures occurred when at least 4 rods were used. In the univariate analysis, the magnitude of surgical correction was higher in the failure cohort (higher preoperative T1-pelvic angle [T1PA], presence of a 3-column osteotomy; p < 0.05). Uncorrected postoperative deformity increased failure risk (pelvic incidence-lumbar lordosis mismatch > 10°, higher postoperative T1PA; p < 0.05). Use of pelvic screws less than 8.5 mm in diameter also increased the likelihood of failure (p < 0.05). In the multivariate analysis, a larger preoperative global deformity as measured by T1PA was associated with failure, male patients were more likely to experience failure than female patients, and there was a strong association with implant manufacturer (p < 0.05). Anterior column support with an L5-S1 interbody fusion was protective against failure (p < 0.05). CONCLUSIONS: Acute catastrophic failures involved large-magnitude surgical corrections and likely resulted from high mechanical strain on the pelvic instrumentation. Patients with large corrections may benefit from anterior structural support placed at the most caudal motion segment and multiple rods connecting to more than 2 pelvic fixation points. If failure occurs, salvage with a minimum of 4 rods and 4 pelvic fixation points can be successful.

Value-based care in the management of spinal disorders: a systematic review of cost-utility analysis.

BACKGROUND: Spinal disorders are a major cause of disability and compromise in health-related quality of life. The direct and indirect costs of treating spinal disorders are estimated at more than $100 billion per year. With limited resources, the cost-utility of interventions is important for allocating resources. QUESTIONS/PURPOSES: We therefore performed a systematic review of the literature on cost-utility for nonoperative and operative interventions for treating spinal disorders. METHODS: We searched four databases for cost-utility analysis studies on low back pain management and identified 1004 items. The titles and abstracts of 752 were screened before selecting 27 studies for inclusion; full texts of these 27 studies were individually evaluated by five individuals. RESULTS: Studies of nonoperative treatments demonstrated greater value for graded activity over physical therapy and pain management; spinal manipulation over exercise; behavioral therapy and physiotherapy over advice; and acupuncture and exercise over usual general practitioner care. Circumferential fusion and femoral ring allograft had greater value than posterolateral fusion and titanium cage, respectively. The relative cost-utility of operative versus nonoperative interventions was variable with the most consistent evidence indicating superior value of operative care for treating spinal disorders involving nerve compression and instability. CONCLUSION: The literature on cost-utility for treating spinal disorders is limited. Studies addressing cost-utility of nonoperative and operative management of low back pain encompass a broad spectrum of diagnoses and direct comparison of treatments based on cost-utility thresholds for comparative effectiveness is limited by diversity among disorders and methods to assess cost-utility. Future research will benefit from uniform methods and comparison of treatments in cohorts with well-defined pathology.

Leadership Principles in Uncertain Times. Presidential Address to the AOA, June 10, 2021: AOA Critical Issues.

ABSTRACT: One of the core foundations of leadership is communication. This past pandemic year gave us lessons in how to improve communication during uncertain times as well as examples of strong leadership in the public sphere. The AOA has formulated important Leadership Principles to guide future educational offerings. I will discuss the importance of these Leadership Principles and give examples of how we can apply these principles.

Delayed Ejaculation After Lumbar Spine Surgery: A Claims Database Analysis.

STUDY DESIGN: Retrospective cohort. OBJECTIVES: Delayed ejaculation (DE) is a distressing condition characterized by a notable delay in ejaculation or complete inability to achieve ejaculation, and there are no existing reports of DE following lumbar spine surgery. Inspired by our institutional experience, we sought to assess national rates of DE following surgery of the lumbar spine. METHODS: We queried the Optum De-identified Clinformatics Database for adult men undergoing surgery of the lumbar spine between 2003 and 2017. The primary outcome was the development of DE within 2 years of surgery. Multivariable logistic regression was performed to identify factors associated with the development of DE. RESULTS: We identified 117 918 men who underwent 162 646 lumbar spine surgeries, including anterior lumbar interbody fusion (ALIF), posterior lumbar fusion (PLF), and more. The overall incidence of DE was 0.09%, with the highest rate among ALIF surgeries at 0.13%. In multivariable analysis, the odds of developing DE did not vary between anterior/lateral lumbar interbody fusion, PLF, and other spine surgeries. A history of tobacco smoking (OR = 1.47, 95% CI 1.00-2.16, P = .05) and obesity (OR = 1.56, 95% CI 1.00-2.44, P = .05) were associated with development of DE. CONCLUSIONS: DE is a rare but distressing complication of thoracolumbar spine surgery, and patients should be queried for relevant symptoms at postoperative visits when indicated.

Healthcare resource utilization and costs 2 years pre- and post-lumbar spine surgery for stenosis: a national claims cohort study of 22,182 cases.

BACKGROUND CONTEXT: Improved understanding of the pre- and postoperative trends in costs and healthcare resource utilization (HCRU) is needed to better inform patient expectations and aid in the development of strategies to minimize the significant healthcare burden associated with lumbar spine surgery. PURPOSE: Examine the time course of costs and HCRU in the 2 years preceding and following elective lumbar spine surgery for stenosis in a large national claims cohort. STUDY DESIGN/SETTING: Retrospective analysis of an administrative claims database (IBM® Marketscan® Research Databases 2007-2015). PATIENT SAMPLE: Adult patients undergoing elective primary single-level lumbar surgery for stenosis with at least 2 years of continuous health plan enrollment pre- and postoperatively. OUTCOME MEASURES: Functional measures, including monthly rates of HCRU (15 categories), monthly gross covered payments (including payments made by the health plan and deductibles and coinsurance paid by the patient) overall, by HCRU category, and by spine versus non-spine-related. METHODS: All available patients were utilized for analysis of HCRU. For analysis of payments, only patients on noncapitated health plans providing accurate financial information were analyzed. Payments were converted to 2015 United States dollars using the medical care component of the consumer price index. Trends in payments and HCRU were plotted on a monthly basis pre- and post-surgery and assessed with regression models. Relationships with demographics, surgical factors, and comorbidities were assessed with multivariable repeated measures generalized estimating equations. RESULTS: Median monthly healthcare payments 2 years prior to surgery were $275 ($22, $868). Baseline HCRU at 2 years preoperatively was stable or only gradually rising (office visits, prescription drug use), but began an increasingly steep rise in many categories 6 to 12 months prior to surgery. Monthly payments began an increasingly steep rise 6 months prior to surgery, reaching a peak of $1,402 ($634, $2,827) in the month prior to surgery. This was driven by an increase in radiology, office visits, PT, injections, prescription medications, ER encounters, and inpatient admissions. Payments dropped dramatically immediately following surgery. Over the remainder of the 2 years, the median total payments declined only slightly, as a continued decline in spine-related payments was offset by gradually increased non-spine related payments as patients aged. By 2 years postoperatively, the percentage of patients using PT and injections returned to within 1% of the baseline levels observed 2 years preoperatively; however, spine-related prescription medication use remained elevated, as did other categories of HCRU (radiology, office visits, lab/diagnostic services, and also rare events such as inpatient admissions, ER encounters, and SNF/IRF). Patients with a fusion component to their surgeries had higher payments and HCRU preoperatively, and this did not resolve postoperatively. Variations in payments and HCRU were also evident among plan types, with patients on comprehensive medical plans-predominantly employer-sponsored supplemental Medicare coverage-utilizing more inpatient, ER, and inpatient rehabilitation & skilled nursing facilities. Patients on high-deductible plans had fewer payments and HCRU across all categories; however, we are unable to distinguish whether this is because they used fewer of these services or if they were paying for these services out of pocket without submitting to the payer. By 2 years postoperatively, 51% of patients had no spine-related monthly payments, while 33% had higher and 16% had lower monthly payments relative to 2 years preoperatively. CONCLUSIONS: This is the first study to characterize time trends in direct healthcare payments and HCRU over an extended period preceding and following spine surgery. Differences among plan types potentially highlight disparities in access to care and plan-related financial mediators of patients' healthcare resource utilization.

Advanced Age Does Not Impact Outcomes After 1-level or 2-level Lateral Lumbar Interbody Fusion.

STUDY DESIGN: This was a retrospective comparative study. OBJECTIVE: The objective of this study was to assess the effect of increased age on perioperative and postoperative complication rates, reoperation rates, and patient-reported pain and disability scores after lateral lumbar interbody fusion (LLIF). SUMMARY OF BACKGROUND DATA: LLIF was developed to minimize soft tissue trauma and reduce the risk of vascular injury; however, there is little evidence regarding the effect of advanced age on outcomes of LLIF. METHODS: Patients who underwent LLIF from 2009 to 2019 at one institution with a minimum 6-month follow-up were retrospectively reviewed. Patients less than 18 years old with musculoskeletal tumor or trauma were excluded. The primary outcome was the preoperative to postoperative change in the Numeric Pain Rating Scale (NPRS) for back pain. Operative time, estimated blood loss, length of stay, perioperative and 90-day complications, unplanned readmissions, reoperations, and change in Oswestry Disability Index were also evaluated. Relationships with age were assessed both with age as a continuous variable and segmenting by age below 70 versus 70+. RESULTS: In total, 279 patients were included. The median age was 65±13 years and 159 (57%) were female. Age was not related to improvements in back NPRS and Oswestry Disability Index. Operative time, estimated blood loss, length of stay, perioperative and 90-day complications, unplanned readmissions, reoperations, and radiographic fusion rate also were not related to age. After multivariable risk adjustment, increasing age was associated with greater improvements in back NPRS. The decrease in back NPRS was 0.68 (95% confidence interval: 0.14, 1.22; P=0.014) points greater for every 10-year increase in age. Age was not associated with rates of complication, readmission, or reoperation. CONCLUSIONS: LLIF is a safe and effective procedure in the elderly population. Advanced age is associated with larger improvements in preoperative back pain. Surgeons should consider the benefits of LLIF and other minimally invasive techniques when evaluating elderly candidates for lumbar fusion. LEVEL OF EVIDENCE: Level III.