Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial.

PURPOSE: To determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis. METHODS: Patients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (-2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data. RESULTS: Thirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (-1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks. CONCLUSION: Pain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control. Clinical Trials Registration Number NCT04308122, April 22, 2020.

Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months.

BACKGROUND: The treatment of chronic sciatica caused by herniation of a lumbar disk has not been well studied in comparison with acute disk herniation. Data are needed on whether diskectomy or a conservative approach is better for sciatica that has persisted for several months. METHODS: In a single-center trial, we randomly assigned patients with sciatica that had lasted for 4 to 12 months and lumbar disk herniation at the L4-L5 or L5-S1 level in a 1:1 ratio to undergo microdiskectomy or to receive 6 months of standardized nonoperative care followed by surgery if needed. Surgery was performed by spine surgeons who used conventional microdiskectomy techniques. The primary outcome was the intensity of leg pain on a visual analogue scale (ranging from 0 to 10, with higher scores indicating more severe pain) at 6 months after enrollment. Secondary outcomes were the score on the Oswestry Disability Index, back and leg pain, and quality-of-life scores at 6 weeks, 3 months, 6 months, and 1 year. RESULTS: From 2010 through 2016, a total of 790 patients were screened; of those patients, 128 were enrolled, with 64 in each group. Among the patients assigned to undergo surgery, the median time from randomization to surgery was 3.1 weeks; of the 64 patients in the nonsurgical group, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment. At baseline, the mean score for leg-pain intensity was 7.7 in the surgical group and 8.0 in the nonsurgical group. The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001). Secondary outcomes including the score on the Owestry Disability Index and pain at 12 months were in the same direction as the primary outcome. Nine patients had adverse events associated with surgery, and one patient underwent repeat surgery for recurrent disk herniation. CONCLUSIONS: In this single-center trial involving patients with sciatica lasting more than 4 months and caused by lumbar disk herniation, microdiskectomy was superior to nonsurgical care with respect to pain intensity at 6 months of follow-up. (Funded by Physicians' Services Incorporated Foundation; ClinicalTrials.gov number, NCT01335646.).

Microdiscectomy Is More Cost-effective Than a 6-Month Nonsurgical Care Regimen for Chronic Radiculopathy.

BACKGROUND: A recent randomized controlled trial (RCT), performed by the authors, comparing early surgical microdiscectomy with 6 months of nonoperative care for chronic lumbar radiculopathy showed that early surgery resulted in improved outcomes. However, estimates of the incremental cost-utility ratio (ICUR), which is often expressed as the cost of gaining one quality-adjusted life year (QALY), of microdiscectomy versus nonsurgical management have varied. Radiculopathy lasting more than 4 months is less likely to improve without surgical intervention and may have a more favorable ICUR than previously reported for acute radiculopathy. QUESTION/PURPOSE: In the setting of chronic radiculopathy caused by lumbar disc herniation, defined as symptoms and/or signs of 4 to 12 months duration, is surgical management more cost-effective than 6 months of nonoperative care from the third-party payer perspective based on a willingness to pay of less than CAD 50,000/QALY? METHODS: A decision analysis model served as the vehicle for the cost-utility analysis. A decision tree was parameterized using data from our single-center RCT that was augmented with institutional microcost data from the Ontario Case Costing Initiative. Bottom-up case costing methodology generates more accurate cost estimates, although institutional costs are known to vary. There were no major surgical cost drivers such as implants or bone graft substitutes, and therefore, the jurisdictional variance would be minimal for tertiary care centers. QALYs derived from the EuroQoL-5D were the health outcome and were derived exclusively from the RCT data, given the paucity of studies evaluating the surgical treatment of lumbar radiculopathy lasting 4 to 12 months. Cost-effectiveness was assessed using the ICUR and a threshold of willingness to pay CAD 50,000 (USD 41,220) per QALY in the base case. Sensitivity analyses were performed to account for the uncertainties within the estimate of cost utility, using both a probabilistic sensitivity analysis and two one-way sensitivity analyses with varying crossover rates after the 6-month nonsurgical treatment had concluded. RESULTS: Early surgical treatment of patients with chronic lumbar radiculopathy (defined as symptoms of 4 to 12 months duration) was cost-effective, in that the cost of one QALY was lower than the CAD 50,000 threshold (note: the purchasing power parity conversion factor between the Canadian dollar (CAD) and the US dollar (USD) for 2019 was 1 USD = 1.213 CAD; therefore, our threshold was USD 41,220). Patients in the early surgical treatment group had higher expected costs (CAD 4118 [95% CI 3429 to 4867]) than those with nonsurgical treatment (CAD 2377 [95% CI 1622 to 3518]), but they had better expected health outcomes (1.48 QALYs [95% CI 1.39 to 1.57] versus 1.30 [95% CI 1.22 to 1.37]). The ICUR was CAD 5822 per QALY gained (95% CI 3029 to 30,461). The 2-year probabilistic sensitivity analysis demonstrated that the likelihood that early surgical treatment was cost-effective was 0.99 at the willingness-to-pay threshold, as did the one-way sensitivity analyses. CONCLUSION: Early surgery is cost-effective compared with nonoperative care in patients who have had chronic sciatica for 4 to 12 months. Decision-makers should ensure adequate funding to allow timely access to surgical care given that it is highly likely that early surgical intervention is potentially cost-effective in single-payer systems. Future work should focus on both the clinical effectiveness of the treatment of chronic radiculopathy and the costs of these treatments from a societal perspective to account for occupational absences and lost patient productivity. Parallel cost-utility analyses are critical so that appropriate decisions about resource allocation can be made. LEVEL OF EVIDENCE: Level III, economic and decision analysis.

Anatomical relationship between the accessory process of the lumbar spine and the pedicle screw entry point.

INTRODUCTION: The vertebra accessory process (or tubercle) of the lumbar spine is an understated landmark which lies caudal to the mammillary process at the base of the transverse process. To our knowledge, no studies compare its relation to pedicle entry point for screw placement. We proposed to evaluate whether a valid and reliable relationship exists between the accessory process and the projected pedicle axis. MATERIAL AND METHODS: The distance between the tip of the accessory process and the entry point of the pedicle screw was measured for 50 pedicles. The angle between this axis and the midline was measured. Interrater reliability was assessed intraclass correlation coefficient for two raters. Statistical analysis of the results was performed using SPSS. RESULTS: The mean distance between the tip of accessory process and pedicle screw entry point was 6.58 mm (SD ±2.05), and the mean angle between this axis and the midline was 29.4° medial (SD ±10.08). The ICC for the two raters for the mean distance and the mean angle was 0.974 and 0.894. The calculated mean distance between the tip of the accessory process and pedicle screw entry point was 3.2 mm (SD ±1.3) and 5.7 mm (SD ±1.9) medial and cranial respectively. CONCLUSIONS: The accessory process is a consistent and reliable landmark to guide pedicle screw entry point, and compliments other screw insertion techniques. To our knowledge, this is the first study in the published literature to assess this relationship.

Radiologic and Clinical Evaluation of Posterolateral Versus Transforaminal Interbody Fusion in Degenerative Lumbar Spondylolisthesis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The primary objective is to compare foraminal height (FH) and disk height (DH) differences in posterolateral (PLF) and transforaminal interbody fusions (TLIFs) and secondarily correlate these measurements with patient-reported outcomes. BACKGROUND: The impact FH has on patient outcomes in degenerative lumbar spinal fusion surgery is unknown. Postoperative FH change and how it relates to patient-reported outcomes in posteriorly based procedures has not been well evaluated. METHODS: A retrospective review of a subset of patients from a prospective cohort from the Canadian Spine Outcomes and Research Network was undertaken. Radiographic assessment preoperatively, at 3 months and 1 year, with standing lumbar spine radiographs were completed. FH and DH were recorded at each time interval, differences between groups were compared, and correlations with patient-reported outcomes were assessed. RESULTS: One hundred nine patients were included (23 PLF and 86 TLIF). At 3-month follow-up, the change in FH was greater in the TLIF group (mean difference =2.3; 95% CI: 0.8-3.5, P =0.002). The change in FH remained significantly different at 12 months (mean difference=1.6, 95% CI: 0.2, 3.0 mm, P =0.028). The change in DH was greater in the TLIF group, with a mean difference between groups of 4.1 mm (95% CI: 2.5, 5.7, P <0.001) and 3.6 mm (95% CI: 2.0, 5.3, P <0.001). A positive change in FH correlated with less back pain, less disability, and improved physical function in the TLIF group ( P <0.05). CONCLUSIONS: Patients treated with PLF lost FH over time. An increased difference in FH at 1 year was associated with improved function and less back pain in the TLIF group.

Differences in the surgical management of degenerative lumbar spondylolisthesis based on self-reported sex: analysis of the CSORN prospective DLS study.

OBJECTIVE: Surgical treatment of degenerative lumbar spondylolisthesis (DLS) reliably improves patient-reported quality of life; however, patient population heterogeneity, in addition to other factors, ensures ongoing equipoise in choosing the ideal surgical treatment. Surgeon preference for fusion or decompression alone influences surgical treatment decision-making. Meanwhile, at presentation, patient-reported outcome measures (PROMs) differ considerably between females and males. The aims of this study were to determine whether there exists a difference in the rates of decompression and fusion versus decompression alone based on patient-reported sex, and to determine if widely accepted indications for fusion justify any observed differences or if surgeon preference plays a role. METHODS: This study is a retrospective cohort analysis of patients enrolled in the Canadian Spine Outcomes Research Network (CSORN) DLS study, a multicentered Canadian prospective study, investigating the surgical management and outcome of DLS. Decompression and fusion rates, patient characteristics, preoperative PROMs, and radiographic measures were compared between males and females before and after propensity score matching. RESULTS: In the unmatched cohort, female patients were more likely to undergo decompression and fusion than male patients. Females were more likely to have the recognized indications for fusion, including kyphotic disc angle, higher spondylolisthesis grade and slip percentage, and patient-reported back pain. Other radiographic findings associated with the decision to fuse, including facet effusion, facet distraction, or facet angle, were not more prevalent in females. After propensity score matching for demographic and radiographic characteristics, similar proportions of male and female patients underwent decompression and fusion and decompression alone. CONCLUSIONS: Although it remains unclear who should or should not undergo fusion, in addition to surgical decompression of DLS, female patients undergo fusion at a higher rate than their male counterparts. After matching baseline radiographic factors indicating fusion, this analysis showed that the decision to fuse was not biased by sex differences. Rather, the higher proportion of females undergoing fusion is largely explained by the radiographic and clinical indications for fusion, suggesting that specific clinical and anatomical features of this condition are indeed different between sexes.

L3-L4 Hyperlordosis and Decreased Lower Lumbar Lordosis Following Short-Segment L4-L5 Lumbar Fusion Surgery is Associated With L3-L4 Revision Surgery for Adjacent Segment Stenosis.

STUDY DESIGN: Retrospective review of prospective cohort. OBJECTIVES: Reoperation at L3-L4 for adjacent segment disease (ASD) is common after L4-L5 spine fusion. L4-S1 lower lumbar lordosis (LLL) accounts for the majority of global lumbar lordosis (GLL) and is modifiable during surgery. We sought to determine if a reduction in LLL leads to an increase in L3-L4 focal lumbar lordosis (L3-L4 FLL) and resulting risk of ASD at L3-L4. METHODS: We reviewed the records of a prospective cohort with lumbar spinal stenosis who underwent L4-L5 or L4-L5-S1 fusion between 2006 and 2012. Radiographic parameters-GLL, LLL, L3-L4 FLL, upper lumbar lordosis, lordosis distribution index, pelvic tilt, and pelvic incidence-were extracted from preoperative and postoperative lumbar spine radiographs. Statistical comparisons were made between those who underwent revision for post-fusion adjacent level stenosis at L3-L4 (REVISION) and those who did not (NO REVISION). RESULTS: Inclusion criteria were met by 104 patients. The REVISION cohort included 19 individuals. No significant differences in baseline demographics or operative details for the index procedure were found between groups. Postoperatively, when compared to the NO REVISION cohort, the REVISION cohort had a decrease in LLL (-2.6° vs + 1.5°, P = .011) and LDI (-5.1% vs + 1.3%, P = .039), and an increase in L3-L4 FLL (+2.6° vs -.6°, P = .001). CONCLUSIONS: A reduction in LLL and compensatory increase in L3-L4 FLL after initial lower lumbar fusion surgery resulted in more reoperation at L3-L4 for post-fusion adjacent level spinal stenosis.

Sagittal alignment in operative degenerative lumbar spondylolisthesis: a scoping review.

Background: The benefit of surgical intervention over conservative treatment for degenerative lumbar spondylolisthesis (DLS) patients with neurologic symptoms is well-established. However, it is currently unclear what breadth of available evidence exists on regional and global sagittal alignment in DLS surgery. As such, the purpose of the current study is to conduct a scoping review to map and synthesize the DLS literature regarding the current radiographic assessment of sagittal spinal alignment in DLS surgery. Methods: A comprehensive search of the MEDLINE, EMBASE and Cochrane databases from January 1971 to January 2023 was performed for all DLS studies examining sagittal spinal alignment parameters with DLS surgery according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review (PRISMA-ScR) protocol. Results: From 2,222 studies, a total of 109 studies were included, representing 10,730 patients with an average age of 63.0 years old and average follow-up of 35.1 months postoperatively. Among included studies, 93 (85%), were largely published in the last decade and predominantly represented retrospective cohorts 70 (64%) or case series 22 (20%). A common theme among the reporting of radiographic parameters in the included investigations was the assessment of the magnitude and/or maintenance of a radiographic change postoperatively, with 92 (84%) studies reporting these findings. The majority of studies focused on index DLS level [33 (30%) studies] or lumbar spine radiographic imaging [33 (30%) studies] only. Thirty-seven (34%) studies reported spinopelvic parameters, with only 13 (12%) of included studies assessing 36-inch standing lateral radiographs and overall alignment. Conclusions: There is increasing prevalence of investigations assessing sagittal spinal alignment parameters in DLS surgery. Although, there is an increasing prevalence of studies investigating sagittal spinal alignment parameters in DLS surgery the quality of the currently available literature on this topic is of overall low evidence and largely retrospective in nature. Additionally, there is limited analysis of global sagittal spinal alignment in DLS suggesting that future investigational emphasis should prioritize longitudinally followed large prospective cohorts or multi-centre randomized controlled trials. Attempts at standardizing the radiographic and functional outcome reporting techniques across multi-centre investigations and prospective cohorts will allow for more robust, reproducible analyses of significance to be conducted on DLS patients.

Functional outcomes correlate with sagittal spinal balance in degenerative lumbar spondylolisthesis surgery.

BACKGROUND CONTEXT: Degenerative lumbar spondylolisthesis (DLS) is a debilitating condition associated with poor preoperative functional status. Surgical intervention has been shown to improve functional outcomes in this population though the optimal surgical procedure remains controversial. The importance of maintaining and/or improving sagittal and pelvic spinal balance parameters has received increasing interest in the recent DLS literature. However, little is known about the radiographic parameters most associated with improved functional outcomes among patients undergoing surgery for DLS. PURPOSE: To identify the effect of postoperative sagittal spinal alignment on functional outcome after DLS surgery. STUDY DESIGN: Retrospective cohort study. PATIENT SAMPLE: Two-hundred forty-three patients in the Canadian Spine Outcomes and Research Network (CSORN) prospective DLS study database. OUTCOME MEASURES: Baseline and 1-year postoperative leg and back pain on the 10-point Numeric Rating Scale and baseline and 1-year postoperative disability on the Oswestry Disability Index (ODI). METHODS: All enrolled study patients had a DLS diagnosis and underwent decompression in isolation or with posterolateral or interbody fusion. Global and regional radiographic alignment parameters were measured at baseline and 1-year postoperatively including sagittal vertical axis (SVA), pelvic incidence and lumbar lordosis (LL). Both univariate and multiple linear regression was used to assess for the association between radiographic parameters and patient-reported functional outcomes with adjustment for possible confounding baseline patient factors. RESULTS: Two-hundred forty-three patients were available for analysis. Among participants, the mean age was 66 with 63% (153/243) female with the primary surgical indication of neurogenic claudication in 197/243 (81%) of patients. Worse pelvic incidence-LL mismatch was correlated with more severe disability [ODI, 0.134, p<.05), worse leg pain (0.143, p<.05) and worse back pain (0.189, p<.001) 1-year postoperatively. These associations were maintained after adjusting for age, BMI, gender, and preoperative presence of depression (ODI, R2 0.179, ß, 0.25, 95% CI 0.08, 0.42, p=.004; back pain R2 0.152 (ß, 0.05, 95% CI 0.022, 0.07, p<.001; leg pain score R2 0.059, ß, 0.04, 95% CI 0.008, 0.07, p=.014). Likewise, reduction of LL was associated with worse disability (ODI, R2 0.168, ß, 0.04, 95% CI -0.39, -0.02, p=.027) and worse back pain (R2 0.135, ß, -0.04, 95% CI -0.06, -0.01, p=.007). Worsened SVA correlated with worse patient reported functional outcomes (ODI, R2 0.236, ß, 0.12, 95% CI 0.05, 0.20, p=.001). Similarly, an increase (worsening) in SVA resulted in a worse NRS back pain (R2 0.136, ß, 0.01, 95% CI .001, 0.02, p=.029) and worse NRS leg pain (R2 0.065, ß, 0.02, 95% CI 0.002, 0.02, p=.018) scores regardless of surgery type. CONCLUSIONS: Preoperative emphasis on regional and global spinal alignment parameters should be considered in order to optimize functional outcome in lumbar degenerative spondylolisthesis treatment.

Early Versus Delayed Microdiscectomy for Chronic Sciatica Lasting 4-12 Months Secondary to Lumbar Disc Herniation: A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVES: To compare the effect of delaying surgery on clinical outcome in patients with chronic sciatica secondary to lumbar disc herniation. METHODS: Patients with sciatica lasting 4-12 months and lumbar disc herniation at the L4-L5 or L5-S1 level were randomized to undergo microdiscectomy (early surgery) or to receive 6 months of nonoperative treatment followed by surgery if needed (delayed surgery). Outcomes were leg pain, Oswestry Disability Index score (ODI), back pain, SF-36 physical component (PCS) and mental component (MCS) summary scores, employment, and satisfaction measured preoperatively and at 6 weeks, 3 months, 6 months, and 1 year after surgery. RESULTS: Of the 64 patients in the early surgery group, 56 underwent microdiscectomy an average of 3 ± 2 weeks after enrollment. Of the 64 patients randomized to nonoperative care, 22 patients underwent delayed surgery an average of 53 ± 24 weeks after enrollment. The early surgery group experienced less leg pain than the delayed surgery group, which was the primary outcome, at 6 months after surgery (early surgery 2.8 ± .4 vs delayed surgery 4.8 ± .7; difference, 2.0; 95% confidence interval, .5-3.5). The overall estimated mean difference between groups significantly favored early surgery for leg pain, ODI, SF36-PCS, and back pain. The adverse event rate was similar between groups. CONCLUSIONS: Patients presenting with chronic sciatica treated with delayed surgery after prolonging standardized non-operative care have inferior outcomes compared to those that undergo expedited surgery.

Patient's expectations of surgery for lumbar degenerative spondylolisthesis: analysis by type of surgery and patient factors from the Canadian Spine Outcomes and Research Network (CSORN).

BACKGROUND CONTEXT: Preoperative expectations influence postoperative outcomes. Patients with lumbar degenerative spondylolisthesis have especially high expectations of pain relief and overall functional well-being compared to patients with lumbar stenosis. PURPOSE: The primary objective was to analyze preoperative expectations of lumbar DS patients with respect to the type of surgery proposed (decompression vs decompression and fusion). Secondarily, we aimed to assess the associations between preoperative expectations and patient and clinical factors as well as postoperative expectations fulfillment. STUDY DESIGN/SETTING: Patients were prospectively enrolled in a multicenter, prospective cohort study evaluating the assessment and management of degenerative spondylolisthesis utilizing the infrastructure of the Canadian Spine Outcomes and Research Network (CSORN) surgical registry. PATIENT SAMPLE: Patients with a diagnosis of degenerative spondylolisthesis with symptoms of neurogenic claudication or radiculopathy with or without back pain, unresponsive to nonoperative management over at least 3 months were included. Patients who underwent decompression, decompression and posterolateral fusion or decompression and interbody fusion at Canadian spine centers between January 2015 and September 2021 were included. OUTCOME MEASURES: The North American Spine Society Lumbar Spine Questionnaire was utilized for expectations measurement. The expectation questionnaire was completed following consent and before surgery and at 1 year. METHODS: Expectations for pain relief and improvements in overall functional well-being were rated on a scale of 0 to 100. Preoperative expectation in terms of pain relief and functional well-being score were calculated. Multivariate linear regression was used to evaluate the association between expected preoperative patient factors and pain relief and functional well-being. The factors associated with the most important expectation were evaluated using multivariable multinomial logistic regression. RESULTS: Three hundred fifty-two patients were included with 100 patients undergoing decompression and 252 patients also undergoing fusion. The seven items of preoperative expectations did not differ between the procedure groups nor did expected change. The mean pain relief and overall functional well-being expectation scores did not significantly differ between procedures. Higher expectations were associated with having more comorbidities [ß=-2.0 (SE 0.8), p=.020], being physically active [ß=8.4 (SE 3.2), p=.010] and having more leg pain [ß=1.6 (SE 0.7), p=.015]. Better perceived physical health measured by SF12 PCS was associated with lower expectation of pain relief [ß= -0.4 (SE 0.2), p=.039] and functional well-being [ß=-0.84 (SE 0.2), p=.001]. Better perceived mental health measured by SF12 MCS was associated with lower expectation of functional well-being [ß=-0.8 (SE 0.2), p=.001]. Postoperative expectations fulfillment did not differ between procedures. CONCLUSION: Preoperative expectations in terms of pain relief and functional well-being were similar between the two most common procedures performed, decompression ± fusion. Secondarily, higher preoperative expectations were associated with greater pain, disability and being physically active. Expectations fulfillment did not differ between procedures.

Guideline adherence and outcomes in esophageal variceal hemorrhage: comparison of tertiary care and non-tertiary care settings.

BACKGROUND: Implementation of consensus guidelines for esophageal variceal hemorrhage yields improved outcomes. We evaluated guideline adherence and outcomes after variceal hemorrhage at a university hospital (UH) and a staff-model health maintenance organization (HMO). STUDY: Factors associated with short-term bleeding, infection, and death were retrospectively identified in UH (n=160) and HMO (n=123) patients with esophageal variceal hemorrhage from January 2000 to December 2006. A second analysis of factors associated with long-term rebleeding was conducted in patients who survived ≥14 days without rebleeding. RESULTS: UH patients were younger, with more severe liver disease and overall illness (P<0.01). UH patients more often received vasoactive agents and prophylactic antibiotics (P<0.01), however the rate of endoscopic therapy did not differ. Infections at 14-days were similar (18.2% vs. 13.0%, P=0.25), but UH patients had greater in-hospital rebleeding (16.4% vs. 5.7%, P<0.01) and mortality (15.2% vs. 4.1%, P<0.01). Poor liver function and overall illness predicted infection, rebleeding, and death (adjusted odds ratio 2.75 to 13.39). Long-term rebleeding occurred in 36.1% of UH patients and 25.9% of HMO patients. Secondary prophylaxis reduced late rebleeding (hazard ratio 0.37 to 0.41). Poor liver function did not predict late rebleeding. Adherence to secondary prophylaxis was greater at the HMO (P<0.05), but late rebleeding did not differ (36% vs. 26%, P=0.13). CONCLUSIONS: Irrespective of practice setting, poor liver function and critical illness predicted short-term bleeding, infection, and death after esophageal variceal hemorrhage, and secondary prophylaxis prevented long-term rebleeding. Differing guideline adherence did not influence outcomes between tertiary care and non-tertiary care centers.

Preoperative Disc Angle is an Important Predictor of Segmental Lordosis After Degenerative Spondylolisthesis Fusion.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: To determine the effect of interbody cages inserted via posterior approach on segmental lordosis in the setting of preoperative lordotic vs kyphotic discs in patients with lumbar degenerative spondylolisthesis (LDS). METHODS: Retrospective analysis of prospectively collected data on assessment and management of LDS patients from 2 contributing centres. Patients were analyzed preoperatively and at 12-month follow-up with standing lumbar radiographs. Index level segmental lumbar lordosis (SLL), disc angle and global lumbar lordosis was measured. Patients were stratified into 4 groups based on index level disc angle and procedure: preoperative lordotic posterolateral fusion (group L-PLF); preoperative kyphotic PLF (group K-PLF); preoperative lordotic interbody fusion (IF) (group L-IF); preoperative kyphotic IF (group K-IF). RESULTS: A total of 100/111 (90%) patients completed follow-up with 40 in group L-IF and 48 in group K-IF. There were 18 patients in group L-PLF and 5 in group K-PLF. Among patients with preoperatively lordotic disc angles who had a worsening of SLL, group L-IF had worse SLL than group L-PLF patients, with differences persisting at one-year (mean difference 2.30, 95% CI, .3, 4.3, P = .029). Patients in group K-IF achieved improvement in SLL at one-year more frequently than group L-IF (67% vs 44%, P = .046), with similar mean improvement magnitude between groups L-IF and K-IF (-1.1, 95% CI, -3.7, 1.6, P = .415). CONCLUSION: Segmental lordosis worsening was greater with preoperative index lordotic disc angles when an interbody cage was used. Patients who have a kyphotic disc preoperatively gain more lordosis with interbody cage use.

Back Dominant Pain Has Equal Outcomes to Radicular Dominant Pain Following Posterior Lumbar Fusion in Adult Isthmic Spondylolisthesis: A CSORN Study.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: This study aimed to determine how the surgeon-determined and patient-rated location of predominant pain influences patient-rated outcomes at 1-year after posterior lumbar fusion in adult isthmic spondylolisthesis. METHODS: We retrospectively reviewed consecutive patients prospectively enrolled in the Canadian Spine Outcomes and Research Network national registry between 2009 and 2017 that underwent posterior lumbar fusion for isthmic spondylolisthesis. Using longitudinal mixed-model repeated-measures analysis the change from baseline in patient-reported outcome measures (PROMs) at 1 year after surgery was compared between surgeon-determined groups (back vs. radicular) and between patient-rated pain groups (back, leg, and equal) derived from preoperative pain scores on the numerical rating scale (NRS). RESULTS: 83/252 (33%) patients had a surgeon-determined chief complaint of back pain, while 103 (41%) patients rated their back pain as the predominant pain location, and 78 (31%) rated their back and leg pain to be equal. At baseline patients in the surgeon-determined radicular group had worse NRS-leg pain than those in the back-pain group but equal NRS-back pain. At baseline patients in the patient-rated equal pain group had similar back pain compared to the patient-rated back pain group and similar leg pain compared to the patient-rated leg pain group. All PROMs improved post-operatively and were not different between the 2 groups at 1 year. CONCLUSIONS: Our study found no difference in outcome, irrespective of whether a surgeon determines the patient's primary pain complaint back or radicular dominant, or the patient rates pain in one location greater than another.

Preoperative Patient-reported Outcomes are not Associated With Sagittal and Spinopelvic Alignment in Degenerative Lumbar Spondylolisthesis.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: The aim of this study was to evaluate whether sagittal and spinopelvic alignment correlate with preoperative patient-reported outcomes (PROs) in degenerative lumbar spondylolisthesis (DLS) with spinal stenosis. SUMMARY OF BACKGROUND DATA: Positive global sagittal balance and spinopelvic malalignment are strongly correlated with symptom severity in adult spinal deformity, but this correlation has not been evaluated in DLS. METHODS: Patients were enrolled in the Canadian Spine Outcomes Research Network (CSORN) prospective DLS study at seven centers between January 2015 and May 2018. Correlation was assessed between the following preoperative PROs: Oswestry Disability Index (ODI), numeric rating scale (NRS) leg pain, and NRS back pain and the following preoperative sagittal radiographic parameters SS, PT, PI, SVA, LL, TK, T1SPI, T9SPI, and PI-LL. Patients were further divided into groups based on spinopelvic alignment: Group 1 PI-LL<10°; Group 2 PI-LL ≥10° with PT <30°; and Group 3 PI-LL ≥10° with PT ≥30°. Preoperative PROs were compared among these three groups and were further stratified by those with SVA <50 mm and SVA ≥50 mm. RESULTS: A total of 320 patients (61% female) with mean age of 66.1 years were included. Mean (SD) preoperative PROs were: NRS leg pain 7.4 (2.1), NRS back pain 7.1 (2.0), and ODI 45.5 (14.5). Preoperative radiographic parameters included: SVA 27.1 (33.4) mm, LL 45.7 (13.4°), PI 57.6 (11.9), and PI-LL 11.8 (14.0°). Weak but statistically significant correlations were observed between leg pain and PT (r = -0.114) and PI (ρ = -0.130), and T9SPI with back pain ( r  = 0.130). No significant differences were observed among the three groups stratified by PI-LL and PT. No significant differences in PROs were observed between patients with SVA <50 mm compared to those with SVA ≥50 mm. CONCLUSION: Sagittal and spinopelvic malalignment do not appear to significantly influence baseline PROs in patients with DLS. LEVEL OF EVIDENCE: Prognostic level II.

A systematic review of metal ion concentrations following instrumented spinal fusion.

PURPOSE: Metallic spinal implants undergo wear and corrosion which liberates ionic or particulate metal debris. The purpose of this study was to identify and review studies that report the concentration of metal ions following multi-level spinal fusion and to evaluate the impact on clinical outcomes. METHODS: Databases (PubMed, EBSCO MEDLINE) were searched up to August 2019 for studies in English-language assessing metal ion levels [chromium (Cr), titanium (Ti), nickel (Ni)] in whole blood, serum, or plasma after spinal fusion using a specific search string. Study, patient, and implant characteristics, method of analysis, metal ion concentration, as well as clinical and radiographic results was extracted. RESULTS: The systematic search yielded 18 studies encompassing 653 patients. 9 studies reported Ti ions, eight reported Cr, and six reported Ni. Ti levels were elevated compared to controls/reference range/preoperative baseline in seven studies with the other two reporting no difference. Cr levels were elevated compared to controls/reference range in seven studies with one reporting no difference. Ni levels showed no difference from controls/reference range in four studies with one reporting above normal and another elevated compared to controls. Radiographic evidence of corrosion, implant failure, pseudarthrosis, revision surgery and adverse reaction reporting was highly variable. CONCLUSION: Metal ions are elevated after instrumented spinal fusion; notably Cr levels from stainless steel implants and Ti from titanium implants. The association between clinical and radiographic outcomes remain uncertain but is concerning. Further research with standardized reporting over longer follow-up periods is indicated to evaluate the clinical impact and minimizing risk.

Geometric and volumetric relationship between human lumbar vertebrae and "Black-bone" MRI-based models.

BACKGROUND: This study will examine the differences between human lumbar vertebrae, three-dimensional (3D) scans of these bones, 3D models based on 'Black-bone' magnetic resonance imaging (MRI) scans, and 3D-printed models. MATERIALS AND METHODS: 3D mesh models were created from the "Black-bone" MRI data from two cadaveric human spines, and then 3D printed. Four models were analysed and compared: anatomic bones, 3D-scanned models, MRI models and 3D-printed models. RESULTS: There was no significant difference between when comparing the average of all measurements between all model types (p = 0.81). The mean dice coefficient was 0.91 (SD 0.016) and the mean Hausdorff distance was 0.37 mm (SD 0.04 mm) when comparing the MRI model to the 3D-scanned model. The mean volumes for the MRI model and the 3D scanned model were 10.42 and 10.04 ml (p = 0.085), respectively. CONCLUSIONS: The 'Black-bone' MRI could be a valid radiation-free alternative to computed tomography for the 3D printing of lumbar spinal biomodels.

The Impact of Surgical Site Infection on Patient Outcomes After Open Posterior Instrumented Thoracolumbar Surgery for Degenerative Disorders.

BACKGROUND: Few reports in the literature have described the long-term outcome of postoperative infection from the patient perspective. The aim of the present study was to determine if complicated surgical site infection (SSI) affects functional recovery and surgical outcomes up to 2 years after posterior instrumented thoracolumbar surgery for the treatment of degenerative disorders. METHODS: This retrospective cohort study involved patients who had been enrolled in a previous randomized controlled trial that examined antibiotic use for open posterior multilevel thoracolumbar or lumbar instrumented fusion procedures. In the present study, patients who had SSI (n = 79) were compared with those who did not (n = 456). Patient-reported outcome measures (PROMs) included the Oswestry Disability Index (ODI), leg and back pain scores on a numeric rating scale, Short Form-12 (SF-12) summary scores, and satisfaction with treatment at 1.5, 3, 6, 12, and 24 months. Surgical outcomes included adverse events, readmissions, and additional surgery. RESULTS: The median time to infection was 15 days. Of the 535 patients, 31 (5.8%) had complicated infections and 48 (9.0%) had superficial infections. Patients with an infection had a higher body mass index (BMI) (p = 0.001), had more commonly received preoperative vancomycin (p = 0.050), were more likely to have had a revision as the index procedure (p = 0.004), had worse preoperative mental functioning (mental component summary score, 40.7 ± 1.6 versus 44.1 ± 0.6), had more operatively treated levels (p = 0.024), and had a higher rate of additional surgery (p = 0.001). At 6 months after surgery, patients who developed an infection scored worse on the ODI by 5.3 points (95% confidence interval [CI], 0.4 to 10.1 points) and had worse physical functioning by -4.0 points (95% CI, -6.8 to -1.2 points). Comparison between the groups at 1 and 2 years showed no difference in functional outcomes, satisfaction with treatment, or the likelihood of achieving the minimum clinically important difference (MCID) for the ODI. CONCLUSIONS: SSI more than doubled the post-discharge emergency room visit and additional surgery rates. Patients with SSI initially (6 months) had poorer overall physical function representing the delay to recovery; however, the negative impact resolved by the first postoperative year. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Geometric and Volumetric Relationship Between Human Lumbar Vertebra and CT-based Models.

RATIONALE AND OBJECTIVES: Crucial to the process of three-dimensional (3D) printing is the knowledge of how the actual structure or organ relates dimensionally to its corresponding medical image. This study will examine the differences between human lumbar vertebrae, 3D scans of these bones, 3D models based on computed tomographic (CT) scans, and 3D-printed models. MATERIALS AND METHODS: CT scans were obtained for six human lumbar spines. The bones were cleaned, and 3D scanned. 3D mesh models were created from the CT data, and then 3D printed. Four models were analyzed: anatomic bones, 3D-scanned models, CT-models, and 3D-printed models. Manual measurements were performed for all model types, and segmentation metric comparisons were performed comparing the 3D-scanned models to the CT-models. RESULTS: There was no statistical difference between manual measurements when comparing each parameter of all model types, except for vertebral width (p = 0.044). There was no statistical difference when comparing the average of all measurements between all model types (p = 0.247). The mean Hausdorff distance was 0.99 mm (SD 0.55 mm) when comparing 3D-scanned model to CT-model. The mean Dice coefficient was 0.90 (SD 0.07) when comparing 3D-scanned model to CT-model. The mean volume for 3D-scanned model and CT-model were 41.6 ml and 45.9 ml (p < 0.001), respectively. CONCLUSION: This study clarifies the geometric and volumetric relationship between human lumbar vertebra and CT-based vertebral models. Segmentation metrics reveal a 1 mm difference between examined bones (using the 3D-scanned bone as a surrogate), and the CT measurements. This is confirmed by a volumetric difference of 4.3 ml, between the larger CT-based model and the smaller bone.