Influence of Prolonged Duration of Symptoms Before MIS-TLIF in a Workers' Compensation Population.

OBJECTIVE: We assessed the potential effect of the preoperative symptom duration on patient-reported outcomes (PROs) for workers' compensation (WC) patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). METHODS: WC patients who had undergone primary, elective MIS-TLIF with recorded symptoms duration data available were included. Two cohorts were generated: those with a shorter (lesser) duration (LD; symptom duration <1 year) and those with a prolonged duration (PD; symptom duration >1 year). PROs were collected preoperatively and at several follow-up points for ≤1 year postoperatively. The PROs were compared within and between the 2 cohorts. The achievement rates of minimum clinically important differences were also compared between the 2 cohorts. RESULTS: A total of 145 patients were included, with 76 in the PD cohort and 69 in the LD cohort. The LD cohort demonstrated improvement in the patient-reported outcomes measurement information system for physical function (PROMIS-PF) at 6 months and 1 year postoperatively, Oswestry disability index (ODI) at 12 weeks and 6 months postoperatively, visual analog scale (VAS) score for back pain at 6 weeks, 12 weeks, and 6 months postoperatively, and VAS score for leg pain at all postoperative points (P ≤ 0.015 for all). The PD cohort demonstrated improvement in the PROMIS-PF at 12 weeks and 6 months postoperatively, ODI at 6 weeks, 12 weeks, and 6 months postoperatively, and VAS score for back pain and leg pain at all postoperative periods (P ≤ 0.007 for all). All the preoperative PROs were superior for the LD cohort (P < 0.001 for all). The LD cohort reported better PROMIS-PF at 6 months and 1 year and ODI at 1 year postoperatively (P ≤ 0.037 for all). The PD cohort was more likely to achieve a minimum clinically important difference in ODI at 6 and 12 weeks postoperatively, VAS score for back pain at 6 weeks postoperatively, and VAS score for leg pain at 6 weeks and 1 year postoperatively and overall (P ≤ 0.036 for all). CONCLUSIONS: Independently of the preoperative symptom duration, WC patients demonstrated improvement in physical function and pain after MIS-TLIF. Patients with a longer symptom duration reported inferior function and pain preoperatively and were more likely to demonstrate clinically significant improvements in disability and pain postoperatively.

Endoscopic Rhizotomy for Facetogenic Back Pain: A Review of the History, Financial Considerations, Patient Selection Criteria, and Clinical Outcomes.

BACKGROUND: Chronic back pain (CBP) is a condition that places a considerable burden on society, with several million people affected in the United States alone. Treatment options to address this problem and relieve CBP are constantly evolving, and one of the most promising treatment modalities for CBP that is refractory to conservative treatment options is endoscopic rhizotomy (ER). METHODS: A thorough search of the PubMed (MEDLINE) database was conducted to assess the full progression of ER from its earliest uses to present day in a historical narrative review of ER, with treatment of facetogenic pain as a model pathology. RESULTS: ER allows for direct visualization and ablation of sensory branches of the dorsal ramus to provide pain relief in up to 80% of patients faced with refractory CBP. This technique has been built upon since the early 20th century, and the novel endoscopic approach continues to gain popularity among physicians. Benefits of ER include superior postoperative median pain-free duration compared with traditional percutaneous radiofrequency ablation, as well as direct visualization of regional anatomy. Patient selection criteria for the procedure and a modest list of contraindications allow the use of ER as a viable treatment option for a significant population of patients suffering from CBP. Potential barriers to ER include high cost of the procedure, longer intraoperative time, and expensive proprietary equipment. CONCLUSIONS: ER is an effective treatment for refractory CBP with notable advantages. As the technology and popularity of this procedure progress, improvements in the cost, training, and intraoperative time may make it a favorable alternative to the current standard of care.

A cost-utility analysis between decompression only and fusion surgery for elderly patients with lumbar spinal stenosis and sagittal imbalance.

Lumbar spinal stenosis (LSS) and sagittal imbalance are relatively common in elderly patients. Although the goals of surgery include both functional and radiological improvements, the criteria of correction may be too strict for elderly patients. If the main symptom of patients is not forward-stooping but neurogenic claudication or pain, lumbar decompression without adding fusion procedure may be a surgical option. We performed cost-utility analysis between lumbar decompression and lumbar fusion surgery for those patients. Elderly patients (age > 60 years) who underwent 1-2 levels lumbar fusion surgery (F-group, n = 31) or decompression surgery (D-group, n = 40) for LSS with sagittal imbalance (C7 sagittal vertical axis, C7-SVA > 40 mm) with follow-up ≥ 2 years were included. Clinical outcomes (Euro-Quality of Life-5 Dimensions, EQ-5D; Oswestry Disability Index, ODI; numerical rating score of pain on the back and leg, NRS-B and NRS-L) and radiological parameters (C7-SVA; lumbar lordosis, LL; the difference between pelvic incidence and lumbar lordosis, PI-LL; pelvic tilt, PT) were assessed. The quality-adjusted life year (QALY) and incremental cost-effective ratio (ICER) were calculated from a utility score of EQ-5D. Postoperatively, both groups attained clinical and radiological improvement in all parameters, but NRS-L was more improved in the F-group (p = 0.048). ICER of F-group over D-group was 49,833 US dollars/QALY. Cost-effective lumbar decompression may be a recommendable surgical option for certain elderly patients, despite less improvement of leg pain than with fusion surgery.

Inferior Clinical Outcomes for Patients with Medicaid Insurance After Surgery for Degenerative Lumbar Spondylolisthesis: A Prospective Registry Analysis of 608 Patients.

BACKGROUND: It remains unclear how type of insurance coverage affects long-term, spine-specific patient-reported outcomes (PROs). This study sought to elucidate the impact of insurance on clinical outcomes after lumbar spondylolisthesis surgery. METHODS: The prospective Quality Outcomes Database registry was queried for patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery. Twenty-four-month PROs were compared and included Oswestry Disability Index, Numeric Rating Scale (NRS) back pain, NRS leg pain, EuroQol-5D, and North American Spine Society Satisfaction. RESULTS: A total of 608 patients undergoing surgery for grade 1 degenerative lumbar spondylolisthesis (mean age, 62.5 ± 11.5 years and 59.2% women) were selected. Insurance types included private insurance (n = 319; 52.5%), Medicare (n = 235; 38.7%), Medicaid (n = 36; 5.9%), and Veterans Affairs (VA)/government (n = 17; 2.8%). One patient (0.2%) was uninsured and was removed from the analyses. Regardless of insurance status, compared to baseline, all 4 cohorts improved significantly regarding ODI, NRS-BP, NRS-LP, and EQ-5D scores (P < 0.001). In adjusted multivariable analyses, compared with patients with private insurance, Medicaid was associated with worse 24-month postoperative Oswestry Disability Index (ß = 10.2; 95% confidence interval [CI], 3.9-16.5; P = 0.002) and NRS leg pain (ß =1.3; 95% CI, 0.3-2.4; P = 0.02). Medicaid was associated with worse EuroQol-5D scores compared with private insurance (ß = -0.07; 95% CI -0.01 to -0.14; P = 0.03), but not compared with Medicare and VA/government insurance (P > 0.05). Medicaid was associated with lower odds of reaching ODI minimal clinically important difference (odds ratio, 0.2; 95% CI, 0.03-0.7; P = 0.02) compared with VA/government insurance. NRS back pain and North American Spine Society satisfaction did not differ by insurance coverage (P > 0.05). CONCLUSIONS: Despite adjusting for potential confounding variables, Medicaid coverage was independently associated with worse 24-month PROs after lumbar spondylolisthesis surgery compared with other payer types. Although all improved postoperatively, those with Medicaid coverage had relatively inferior improvements.

A 24-month retrospective update: follow-up hospitalization charges and readmissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2).

BACKGROUND: The objectives of this study were to build upon previously-reported 12-month findings by retrospectively comparing 24-month follow-up hospitalization charges and potentially-relevant readmissions in US lumbar fusion surgeries that employed either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a nationwide healthcare system database. METHODS: A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2 in the original study, of whom 3,792 patients (23.4%) were identified in the current study with all-cause readmissions during the 24-month follow-up period. Confounding baseline patient, procedure, and hospital characteristics found in the original study were used to adjust multivariate regression models comparing differences in 24-month follow-up hospitalization charges (in 2020 US dollars) and lengths of stay (LOS; in days) between the groups. Differences in potentially-relevant follow-up readmissions were also compared, and all analyses were repeated in the subset of patients who only received treatment at a single level of the spine. RESULTS: The adjusted cumulative mean 24-month follow-up hospitalization charges in the full cohort were significantly lower in the V-CBA group ($99,087) versus the rhBMP-2 group ($124,389; P < 0.0001), and this pattern remained in the single-level cohort (V-CBA = $104,906 vs rhBMP-2 = $125,311; P = 0.0006). There were no differences between groups in adjusted cumulative mean LOS in either cohort. Differences in the rates of follow-up readmissions aligned with baseline comorbidities originally reported for the initial procedure. Subsequent lumbar fusion rates were significantly lower for V-CBA patients in the full cohort (10.12% vs 12.00%; P = 0.0002) and similar between groups in the single-level cohort, in spite of V-CBA patients having significantly higher rates of baseline comorbidities that could negatively impact clinical outcomes, including bony fusion. CONCLUSIONS: The results of this study suggest that use of V-CBA for lumbar fusion surgeries performed in the US is associated with substantially lower 24-month follow-up hospitalization charges versus rhBMP-2, with both exhibiting similar rates of subsequent lumbar fusion procedures and potentially-relevant readmissions.

Assessment of Rod Material Types in Spine Surgery Outcomes: A Systematic Review.

BACKGROUND: Lumbar spine fusion surgery is traditionally performed with rigid fixation. Because the rigidity is often supraphysiologic, semirigid rods were developed. To the best of our knowledge, a comprehensive evaluation of rod material type on surgical outcomes has yet to be conducted. METHODS: A systematic review based on PRISMA guidelines was conducted across 3 electronic databases. After examination for inclusion and exclusion criteria, data were extracted from the studies. RESULTS: Seventeen studies, including 1399 patients, were included in this review. The mean rigid rod fusion rate is 92.2% and 95.5% for semirigid rods (P = 0.129). The mean improvement in back pain was 60.6% in rigid rods and 71.6% in semirigid rods. The improvement in leg pain was 81.9% and 77.2%, respectively. There were no differences in visual analog scale back pain score (P = 0.098), visual analog scale leg pain score (P = 0.136), or in functional improvement between rigid and semirigid rods (P = 0.143). There was no difference (P = 0.209) in the reoperation rate between rigid rods (13.1%) and semirigid rods (6.5%). There was a comparable incidence of adjacent segment disease (3%), screw fracture (1.7%), and wound infection (1.9%) between rod material types. CONCLUSIONS: There is a moderate level of evidence supporting that surgical intervention results in high fusion rates regardless of rod material type. Surgical intervention improves back pain, leg pain, and function, with neither material type showing clear superiority. There are comparable rates of reoperation, development of adjacent segment disease, development of mechanical complications, and incidence of infection in both rigid and semirigid rods. Further studies regarding rod material type are warranted.

The bird's-eye view: A data-driven approach to understanding patient journeys from claims data.

OBJECTIVE: In preference-sensitive conditions such as back pain, there can be high levels of variability in the trajectory of patient care. We sought to develop a methodology that extracts a realistic and comprehensive understanding of the patient journey using medical and pharmaceutical insurance claims data. MATERIALS AND METHODS: We processed a sample of 10 000 patient episodes (comprised of 113 215 back pain-related claims) into strings of characters, where each letter corresponds to a distinct encounter with the healthcare system. We customized the Levenshtein edit distance algorithm to evaluate the level of similarity between each pair of episodes based on both their content (types of events) and ordering (sequence of events). We then used clustering to extract the main variations of the patient journey. RESULTS: The algorithm resulted in 12 comprehensive and clinically distinct patterns (clusters) of patient journeys that represent the main ways patients are diagnosed and treated for back pain. We further characterized demographic and utilization metrics for each cluster and observed clear differentiation between the clusters in terms of both clinical content and patient characteristics. DISCUSSION: Despite being a complex and often noisy data source, administrative claims provide a unique longitudinal overview of patient care across multiple service providers and locations. This methodology leverages claims to capture a data-driven understanding of how patients traverse the healthcare system. CONCLUSIONS: When tailored to various conditions and patient settings, this methodology can provide accurate overviews of patient journeys and facilitate a shift toward high-quality practice patterns.

Treatments and Health Outcomes of Medicare Patients With Back Pain.

Back pain treatments are costly and frequently involve use of procedures that may have minimal benefit on improving patients' functional status. Two recent studies evaluated adverse outcomes (mortality and major medical complications) following receipt of spinal surgery but neither examined whether such treatments affected functional ability. Using a sample composed of Medicare patients with persistent back pain, we examined whether functional ability improved after treatment, comparing patients treated with back surgery or spinal injections to nonrecipients. We analyzed four binary variables that measure whether the ability to perform routine tasks improved. We used instrumental variables analysis to address the nonrandom selection of treatment received due to unobservable confounding. Contrary to the observational results, the instrumental variable estimates suggest that receipt of either back surgery or spinal injections does not improve back patients' functional ability. Failure to account for selection into treatment can lead to overestimating the benefits of specific treatments.

Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain: a Retrospective Cohort Study in the US Fee-for-Service Medicare Population.

PURPOSE OF REVIEW: To assess patterns of utilization and variables of facet joint interventions in managing chronic spinal pain in a fee-for-service (FFS) Medicare population from 2009 to 2016, with a comparative analysis from 2000 to 2009 and 2009 to 2016. RECENT FINDINGS: From 2009 to 2016, facet joint interventions increased at an annual rate of 2% per 100,000 Medicare population compared to 10.2% annual rate of increase from 2000 to 2009. Lumbosacral facet joint nerve block episodes decreased at an annual rate of 0.1% from 2009 to 2016, with an increase of 16.2% from 2000 to 2009. In contrast, lumbosacral facet joint neurolysis episodes increased at an annual rate of 7.6% from 2009 to 2016 and the utilization rate also increased at an annual rate of 26% from 2000 to 2009. The ratio of lumbar facet joint block episodes to lumbosacral facet joint neurolysis episodes changed from 6.7 in 2000 to 2.2 in 2016. From 2009 to 2016, cervical and thoracic facet joint injections increased at an annual rate of 0.6% compared to cervicothoracic facet neurolysis episodes of 9.2%. During 2000 to 2009, annual increase of cervical facet joint injections was 18% compared to neurolysis procedures of 26%. The ratio of cervical facet joint injections episodes to neurolysis episodes changed from 8.85 in 2000 to 2.8 in 2016. In summary, based on available data, utilization patterns of facet joint interventions demonstrated an increase of 2% per 100,000 Medicare population from 2009 to 2016, with an annual decline of lumbar facet joint injection episodes.

SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial.

INTRODUCTION: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial -the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. METHODS AND ANALYSIS: SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. ETHICS AND DISSEMINATION: Ethics approval has been granted by the NSW Health (reference:17/247/POWH/601) and the Monash University (reference: 12371) Human Research Ethics Committees. Dissemination of results will be via journal articles and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12617000884303; Pre-results.

Association between payer status and patient-reported outcomes in adult patients with lumbar spinal stenosis treated with decompression surgery.

OBJECTIVE: Insurance disparities can have relevant effects on outcomes after elective lumbar spinal surgery. The aim of this study was to evaluate the association between private/public payer status and patient-reported outcomes in adult patients who underwent decompression surgery for lumbar spinal stenosis. METHODS: A sample of 100 patients who underwent surgery for lumbar spinal stenosis from 2012 to 2014 was evaluated as part of the prospectively collected Quality Outcomes Database at a single institution. Outcome measures were evaluated at 3 months and 12 months, analyzed in regard to payer status (private insurance vs Medicare/Veterans Affairs insurance), and adjusted for potential confounders. RESULTS: At baseline, patients had similar visual analog scale back and leg pain, Oswestry Disability Index, and EQ-5D scores. At 3 months postintervention, patients with government-funded insurance reported significantly worse quality of life (mean difference 0.11, p < 0.001) and more leg pain (mean difference 1.26, p = 0.05). At 12 months, patients with government-funded insurance reported significantly worse quality of life (mean difference 0.14, p < 0.001). There were no significant differences at 3 months or 12 months between groups for back pain (p = 0.14 and 0.43) or disability (p = 0.19 and 0.15). Across time points, patients in both groups showed improvement at 3 months and 12 months in all 4 functional outcomes compared with baseline (p < 0.001). CONCLUSIONS: Both private and public insurance patients had significant improvement after elective lumbar spinal surgery. Patients with public insurance had slightly less improvement in quality of life after surgery than those with private insurance but still benefited greatly from surgical intervention, particularly with respect to functional status.

The five-repetition sit-to-stand test: evaluation of a simple and objective tool for the assessment of degenerative pathologies of the lumbar spine.

OBJECTIVE: Recently, objective functional tests have generated interest since they can supplement an objective dimension to clinical assessment. The five-repetition sit-to-stand (5R-STS) test is a quick and objective tool that tests movements frequently used in everyday life. The aim of this prospective study was to evaluate the validity and reliability of the 5R-STS test in patients with degenerative pathologies of the lumbar spine. METHODS: Patients and healthy volunteers completed the standardized 5R-STS, Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), visual analog scale (VAS) for back and leg pain, and EQ-5D for health-related quality of life (HRQOL). To assess convergent validity, the 5R-STS test times were correlated with these questionnaires. RESULTS: Overall, 157 patients and 80 volunteers were enrolled. Direct correlation with RMDQ (r = 0.49), ODI (r = 0.44), and VAS for back pain (r = 0.31) and indirect correlation with the EQ-5D index (r = -0.41) were observed (p < 0.001). The 5R-STS test showed no correlation with VAS for leg pain and EQ-5D VAS (p > 0.05). In 119 individuals, the 5R-STS test demonstrated excellent test-retest reliability with an intraclass correlation coefficient of 0.98. The upper limit of normal, distinguishing patients with and without objective functional impairment, was identified as 10.35 seconds. A severity stratification classified patients with test times of 10.5-15.2, 15.3-22.0, or greater than 22.0 seconds as having mild, moderate, or severe functional impairment, respectively. CONCLUSIONS: The 5R-STS test is a simple and effective tool to describe objective functional impairment. A patient able to perform the test in 10.4 seconds can be considered to have no relevant objective functional impairment. Clinical trial registration no.: NCT03303300 (clinicaltrials.gov).

Opioid Dependence and Prolonged Length of Stay in Lumbar Fusion: A Retrospective Study Utilizing the National Inpatient Sample 2003-2014.

STUDY DESIGN: Retrospective cohort utilizing the National Inpatient Sample (NIS) 2003 to 2014. OBJECTIVE: To investigate the association of opioid dependence with prolonged length of stay (LOS), costs, and surgical complications in elective one-to-two level lumbar fusion. SUMMARY OF BACKGROUND DATA: Opioids are the most commonly prescribed drug class to treat back pain. Few studies have examined the impact of opioid dependence on spinal fusion outcomes. The data available show inconsistent conclusions regarding the association between opioid dependence and LOS. METHODS: Data from 1,826,868 adult elective one-to-two level lumbar fusion discharges in the NIS from 2003 to 2014 were included. Discharges were categorized into an opioid-dependent or unaffected cohort based on the presence or absence of an International Classification of Disease, Ninth Revision-Clinical Modification (ICD-9-CM) code for opioid dependence. Incidence of opioid dependence was compared between 2003 and 2014 via adjusted Wald tests. Patient and surgical characteristics, costs, and complications were compared between cohorts via chi-square tests or adjusted Wald tests for categorical and continuous variables, respectively. Patient and surgical factors were tested for association with prolonged LOS via univariable logistic regressions, and significant (P ≤ 0.01) factors were included in a multivariable logistic regression. RESULTS: Seven thousand nine hundred sixty-four (0.44%) discharges included a diagnosis of opioid dependence. The incidence of opioid dependence increased from 2003 to 2014. Opioid dependence was associated with an adjusted 2.11 times higher odds of prolonged LOS. Opioid-dependent discharges accrued higher costs and had higher frequencies of infection, device-related complications, hematoma- or seroma-related complications, acute posthemorrhagic anemia, and pulmonary insufficiency. CONCLUSION: This nationally-representative study suggests that opioid dependence is associated with prolonged LOS in lumbar fusion, as well as higher costs and higher frequencies of surgical complications. Further investigations are needed to determine the optimal method to treat opioid-dependent patients who require lumbar fusion. LEVEL OF EVIDENCE: 3.

Assessment of radiographic and clinical outcomes of an articulating expandable interbody cage in minimally invasive transforaminal lumbar interbody fusion for spondylolisthesis.

OBJECTIVE The inability to significantly improve sagittal parameters has been a limitation of minimally invasive surgery for transforaminal lumbar interbody fusion (MIS TLIF). Traditional cages have a limited capacity to restore lordosis. This study evaluates the use of a crescent-shaped articulating expandable cage (Altera) for MIS TLIF. METHODS This is a retrospective review of 1- and 2-level MIS TLIF. Radiographic outcomes included differences in segmental and lumbar lordosis, disc height, evidence of fusion, and any endplate violations. Clinical outcomes included the numeric rating scale for leg and back pain and the Oswestry Disability Index (ODI) for low-back pain. RESULTS Thirty-nine patients underwent single-level MIS TLIF, and 5 underwent 2-level MIS TLIF. The mean age was 63.1 years, with 64% women. On average, spondylolisthesis was corrected by 4.3 mm (preoperative = 6.69 mm, postoperative = 2.39 mm, p < 0.001), the segmental angle was improved by 4.94° (preoperative = 5.63°, postoperative = 10.58°, p < 0.001), and segmental height increased by 3.1 mm (preoperative = 5.09 mm, postoperative = 8.19 mm, p < 0.001). At 90 days after surgery the authors observed the following: a smaller postoperative sagittal vertical axis was associated with larger changes in back pain at 90 days (r = -0.558, p = 0.013); a larger decrease in spondylolisthesis was associated with greater improvements in ODI and back pain scores (r = -0.425, p = 0.043, and r = -0.43, p = 0.031, respectively); and a larger decrease in pelvic tilt (PT) was associated with greater improvements in back pain (r = -0.548, p = 0.043). For the 1-year PROs, the relationship between the change in PT and changes in ODI and numeric rating scale back pain were significant (r = 0.612, p = 0.009, and r = -0.803, p = 0.001, respectively) with larger decreases in PT associated with larger improvements in ODI and back pain. Overall for this study there was a 96% fusion rate. Fourteen patients were noted to have endplate violation on intraoperative fluoroscopy during placement of the cage. Only 3 of these had progression of their subsidence, with an overall subsidence rate of 6% (3 of 49) visible on postoperative CT. CONCLUSIONS The use of this expandable, articulating, lordotic, or hyperlordotic interbody cage for MIS TLIF provides a significant restoration of segmental height and segmental lordosis, with associated improvements in sagittal balance parameters. Patients treated with this technique had acceptable levels of fusion and significant reductions in pain and disability.

Preoperative Opioid Use is a Predictor of Poor Return to Work in Workers' Compensation Patients After Lumbar Diskectomy.

STUDY DESIGN: A retrospective cohort. OBJECTIVE: The aim of this study was to determine the impact of preoperative opioid use in workers' compensation (WC) patients undergoing lumbar diskectomy (LD). SUMMARY OF BACKGROUND DATA: The prevalence of back pain among opioid users approached 60%. Long-term opioid dependence in spine surgery patients is roughly 20%. Despite pervasive use, there is no evidence to support long-term opioid analgesic use for back pain. METHODS: Ten thousand five hundred ninety-two patients received compensation from the Ohio Bureau of Workers' Compensation for a lumbar disc herniation between 2005 and 2012. Patients with spine comorbidities, smoking history, or multilevel surgery were excluded. Preoperatively, 566 patients had no opioid use, 126 had short-term opioid use (STO), 315 had moderate opioid use (MTO), and 279 had long-term opioid use (LTO). The primary outcome was whether subjects returned to work (RTW). RESULTS: Seven hundred twelve (55.4%) patients met our RTW criteria. There was a significant difference in RTW rates among the no opioid (64.1%), MTO (52.7%), and LTO (36.9%) populations. Multivariate logistic regression analysis found several covariates to be independent negative predictors of RTW status: preoperative opioid use [P < 0.01; odds ratio (OR) = 0.54], time to surgery (P < 0.01; OR = 0.98 per month), legal representation (P < 0.01; OR = 0.57), and psychiatric comorbidity (P = 0.02; OR = 0.36). Patients in the LTO group had higher medical costs (P < 0.01), rates of psychiatric comorbidity (P < 0.01), incidence of failed back surgery syndrome (FBSS) (P < 0.01), and postoperative opioid use (P < 0.01) compared with the STO and no opioid groups. CONCLUSION: Preoperative opioid use was determined to be a negative predictor of RTW rates after LD in WC patients. In addition, long-term preoperative opioid use was associated with higher medical costs, psychiatric illness, FBSS, and postoperative opioid use. Even a short or moderate course of preoperative opioids was associated with worse outcomes compared with no use. For WC patients undergoing LD, judicious use of preoperative opioid analgesics may improve clinical outcomes and reduce the opioid burden. LEVEL OF EVIDENCE: 3.

Spine surgery outcome in patients who sought compensation after a motor vehicle accident: a retrospective cohort study.

BACKGROUND: Back and neck pain are common after road traffic injury and are treated by spine surgery in some cases. This study aimed to describe the outcomes of spine surgery in people who made an insurance claim after road traffic accidents without an associated spinal fracture or dislocation. METHODS: This study was a retrospective cohort based on insurers' data of Compulsory Third Party (CTP) claims. File audit and data extraction were undertaken using a study-specific proforma. Primary outcomes were ongoing pain and symptoms, complications, return to work and pre-injury duties, and ongoing treatment 2 years following spine surgery. Secondary outcomes were health care costs based on data provided by the insurers. RESULTS: After screening 766 files, 90 cases were included (female: 48; mean age: 46 years). Among the subjects who were working prior the injury, the rate of return to work was 37% and return to pre-injury duties was 23% 2 years following the surgery. The average number of appointments with health care professionals in the 1 year after surgery was 21, compared to 10 for the 1 year prior to surgery (p = 0.03). At 2 years following the initial surgery, 21% of claimants had undergone revision spine surgery; 68% reported ongoing back pain and 41% had ongoing radicular symptoms. The difference between costs 1 year before and after surgery (excluding surgical costs) was statistically significant (p = 0.04). Fusions surgery was associated with higher total costs than decompression alone. After adjusting for surgery type, lumbar surgery was associated with higher costs in the 1 year after surgery and total surgical costs compared to cervical surgery. CONCLUSIONS: The majority of claimants continued having clinical symptoms, continued using health care and did not return to work despite undertaking spine surgery.

A protocol of a randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis: the Lumbar Interbody Fusion Trial (LIFT).

BACKGROUND: With a steep increase in the number of instrumented spinal fusion procedures, there is a need for comparative data to develop evidence based treatment recommendations. Currently, the available data on cost and clinical effectiveness of the two most frequently performed surgeries for lumbar spondylolisthesis, transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), are not sufficient. Therefore, current guidelines do not advise which is the most appropriate surgical treatment strategy for these patients. Non-randomized studies comparing TLIF and PLIF moreover suggest that TLIF is associated with fewer complications, less blood loss, shorter surgical time and hospital duration. TLIF may therefore be more cost-effective. The results of this study will provide knowledge on short- and long-term clinical and economical effects of TLIF and PLIF procedures, which will lead to recommendations for treating patients with lumbar spondylolisthesis. METHODS: Multicenter blinded Randomized Controlled Trial (RCT; blinding for the patient and statistician, not for the clinician and researcher). A total of 144 patients over 18 years old with symptomatic single level lumbar degenerative, isthmic or iatrogenic spondylolisthesis whom are candidates for LIF (lumbar interbody fusion) surgery through a posterior approach will be randomly allocated to TLIF or PLIF. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) a process evaluation. The primary clinical outcome measures are: change in disability measured with Oswestry Disability Index (ODI) and change in quality adjusted life years (QALY) measured with EQ-5D-5L. Secondary clinical outcome measures are: Short Form (36) Health Survey (SF-36), VAS back pain, VAS leg pain, Hospital Anxiety Depression Scale (HADS), complications, productivity related costs (iPCQ) and medical costs (iMCQ). Measurements will be carried out at five fixed time points (pre-operatively and at 3, 6, 12 and 24 months). DISCUSSION: It is hypothesized that TLIF, compared to PLIF, has similar clinical outcome or is possibly better in reducing disability. Moreover, direct medical costs are expected to be lower due to less surgical morbidity, shorter hospital stay and shorter surgical time. Indirect costs are assumed to be lower for TLIF as well, because we suspect less working days are lost. Currently, prospective data comparing clinical and cost-effectiveness of both techniques are not available. Therefore, in clinical practice both techniques are used and the choice for technique is greatly based on surgeon's preference. The demand for spinal fusion surgery has risen steeply over the last 10 years and is expected to increase even further in the near future. As a result, the burden on society (and the working population) will increase. In case our hypothesis is confirmed, treatment guidelines will be adapted, and TLIF will be recommended as first choice surgical treatment of lumbar spondylolisthesis. Ultimately this will lead to reduction of (direct and indirect) costs and better clinical outcome for spondylolisthesis patients eligible for instrumented spinal surgery. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry, number 5722 (registration date March 30, 2016).

Modeled cost-effectiveness of transforaminal lumbar interbody fusion compared with posterolateral fusion for spondylolisthesis using N(2)QOD data.

OBJECTIVE Transforaminal lumbar interbody fusion (TLIF) has become the most commonly used fusion technique for lumbar degenerative disorders. This suggests an expectation of better clinical outcomes with this technique, but this has not been validated consistently. How surgical variables and choice of health utility measures drive the cost-effectiveness of TLIF relative to posterolateral fusion (PSF) has not been established. The authors used health utility values derived from Short Form-6D (SF-6D) and EQ-5D and different cost-effectiveness thresholds to evaluate the relative cost-effectiveness of TLIF compared with PSF. METHODS From the National Neurosurgery Quality and Outcomes Database (N(2)QOD), 101 patients with spondylolisthesis who underwent PSF were propensity matched to patients who underwent TLIF. Health-related quality of life measures and perioperative parameters were compared. Because health utility values derived from the SF-6D and EQ-5D questionnaires have been shown to vary in patients with low-back pain, quality-adjusted life years (QALYs) were derived from both measures. On the basis of these matched cases, a sensitivity analysis for the relative cost per QALY of TLIF versus PSF was performed in a series of cost-assumption models. RESULTS Operative time, blood loss, hospital stay, and 30-day and 90-day readmission rates were similar for the TLIF and PSF groups. Both TLIF and PSF significantly improved back and leg pain, Oswestry Disability Index (ODI) scores, and EQ-5D and SF-6D scores at 3 and 12 months postoperatively. At 12 months postoperatively, patients who had undergone TLIF had greater improvements in mean ODI scores (30.4 vs 21.1, p = 0.001) and mean SF-6D scores (0.16 vs 0.11, p = 0.001) but similar improvements in mean EQ-5D scores (0.25 vs 0.22, p = 0.415) as patients treated with PSF. At a cost per QALY threshold of $100,000 and using SF-6D-based QALYs, the authors found that TLIF would be cost-prohibitive compared with PSF at a surgical cost of $4830 above that of PSF. However, with EQ-5D-based QALYs, TLIF would become cost-prohibitive at an increased surgical cost of $2960 relative to that of PSF. With the 2014 US per capita gross domestic product of $53,042 as a more stringent cost-effectiveness threshold, TLIF would become cost-prohibitive at surgical costs $2562 above that of PSF with SF-6D-based QALYs or at a surgical cost exceeding that of PSF by $1570 with EQ-5D-derived QALYs. CONCLUSIONS As with all cost-effectiveness studies, cost per QALY depended on the measure of health utility selected, durability of the intervention, readmission rates, and the accuracy of the cost assumptions.

A Cost-Effectiveness Comparison Between Open Transforaminal and Minimally Invasive Lateral Lumbar Interbody Fusions Using the Incremental Cost-Effectiveness Ratio at 2-Year Follow-up.

BACKGROUND: Direct cost comparisons between minimally invasive spine surgeries and the open options are rare. OBJECTIVE: To compare healthcare costs associated with open transforaminal lumbar interbody fusion (TLIF) and minimally invasive lateral lumbar interbody fusion (LLIF) by calculating the incremental cost-effectiveness ratio (ICER) and to calculate the thresholds for minimum clinically important difference and minimum cost-effective difference for patient-reported outcome measures at the 2-year follow-up. METHODS: Forty-five patients who underwent single-level TLIF and 29 patients who underwent single-level stand-alone LLIF were included in the comparison. All costs from diagnosis through the 2-year follow-up were available from a comprehensive single-center data bank within a unified hospital system. Payment provided for all spine-related medical resource use from the time of diagnosis through 2 years was recorded. A 0% discount rate was applied. Quality-adjusted life-years (QALYs) were calculated from the EuroQol-5D collected in an unbiased manner. Difference in total cost per QALY gained for LLIF minus that for TLIF was assessed as the estimate of the ICER from a US perspective. RESULTS: Significant improvements were observed at the 2-year follow-up for both TLIF and LLIF with the Short Form-36 physical component summary, Oswestry Disability Index, visual analog scale back pain and leg pain scores, and EuroQol-5D. ICER calculations revealed similar mean cumulative QALYs gained at the 2-year interval (0.67 for TLIF and 0.60 for LLIF; P = .33). Median total costs of care after TLIF and LLIF were $44 068 and $45 574, respectively (P = .96). Minimum cost-effective difference thresholds with an anchor of <$50 000 per QALY were higher than minimum clinically important difference thresholds for all patient-reported outcome measures. Total mean cost and EuroQol-5D were statistically equivalent between the 2 treatment groups. CONCLUSION: TLIF and LLIF produced equivalent 2-year patient outcomes at an equivalent cost-effectiveness profile.

Response assessment after stereotactic body radiotherapy for spinal metastasis: a report from the SPIne response assessment in Neuro-Oncology (SPINO) group.

The SPine response assessment In Neuro-Oncology (SPINO) group is a committee of the Response Assessment in Neuro-Oncology working group and comprises a panel of international experts in spine stereotactic body radiotherapy (SBRT). Here, we present the group's first report on the challenges in standardising imaging-based assessment of local control and pain for spinal metastases. We review current imaging modalities used in SBRT treatment planning and tumour assessment and review the criteria for pain and local control in registered clinical trials specific to spine SBRT. We summarise the results of an international survey of the panel to establish the range of current practices in assessing tumour response to spine SBRT. The ultimate goal of the SPINO group is to report consensus criteria for tumour imaging, clinical assessment, and symptom-based response criteria to help standardise future clinical trials.