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Alexandra Stratton, Karla Gustafson, Kenneth Thomas, and Matthew T. James

OBJECTIVE

Spinal epidural abscess (SEA) is a life-threatening infection. It is uncertain whether medical versus surgical treatment is the ideal initial approach for neurologically intact patients with SEA. Recent evidence demonstrates that initial medical management is increasingly common; however, patients who ultimately require surgery after failed medical management may have a worse prognosis than those whose treatment was initially surgical. The primary objective of this study was to establish the current incidence of failed medical management for SEA. The secondary aim was to identify risk factors associated with the failure of medical management.

METHODS

The authors conducted a systematic review and meta-analysis by searching electronic databases (MEDLINE, Embase, CINAHL, and PubMed), recent conference proceedings, and reference lists of relevant articles. Studies that reported original data on consecutive adult patients with SEA treated medically were eligible for inclusion.

RESULTS

Twelve studies met the inclusion criteria, which included a total of 489 medically treated patients with SEA. Agreement on articles for study inclusion was very high between the reviewers (kappa 0.86). In a meta-analysis, the overall pooled risk of failed medical management was 29.3% (95% CI 21.4%–37.2%) and when medical to surgical crossover was used to define failure the rate was 26.3% (95% CI 13.0%–39.7%). Only 6 studies provided data for analysis by intended treatment, with a pooled estimate of 35.1% (95% CI 15.7%–54.4%) of failed medical management. Two studies reported predictors of the failure of medical management.

CONCLUSIONS

Although the incidence of failed medical management of SEA was relatively common in published reports, estimates were highly heterogeneous between studies, thus introducing uncertainty about the frequency of this risk. A consensus definition of failure is required to facilitate comparison of failure rates across studies.

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Oliver G. S. Ayling, Raphaele Charest-Morin, Matthew E. Eagles, Tamir Ailon, John T. Street, Nicolas Dea, Greg McIntosh, Sean D. Christie, Edward Abraham, W. Bradley Jacobs, Christopher S. Bailey, Michael G. Johnson, Najmedden Attabib, Peter Jarzem, Michael Weber, Jerome Paquet, Joel Finkelstein, Alexandra Stratton, Hamilton Hall, Neil Manson, Y. Raja Rampersaud, Kenneth Thomas, and Charles G. Fisher

OBJECTIVE

Previous works investigating rates of adverse events (AEs) in spine surgery have been retrospective, with data collection from administrative databases, and often from single centers. To date, there have been no prospective reports capturing AEs in spine surgery on a national level, with comparison among centers.

METHODS

The Spine Adverse Events Severity system was used to define the incidence and severity of AEs after spine surgery by using data from the Canadian Spine Outcomes and Research Network (CSORN) prospective registry. Patient data were collected prospectively and during hospital admission for those undergoing elective spine surgery for degenerative conditions. The Spine Adverse Events Severity system defined minor and major AEs as grades 1–2 and 3–6, respectively.

RESULTS

There were 3533 patients enrolled in this cohort. There were 85 (2.4%) individual patients with at least one major AE and 680 (19.2%) individual patients with at least one minor AE. There were 25 individual patients with 28 major intraoperative AEs and 260 patients with 275 minor intraoperative AEs. Postoperatively there were 61 patients with a total of 80 major AEs. Of the 487 patients with minor AEs postoperatively there were 698 total AEs. The average enrollment was 321 patients (range 47–1237 patients) per site. The rate of major AEs was consistent among sites (mean 2.9% ± 2.4%, range 0%–9.1%). However, the rate of minor AEs varied widely among sites—from 7.9% to 42.5%, with a mean of 18.8% ± 9.7%. The rate of minor AEs varied depending on how they were reported, with surgeon reporting associated with the lowest rates (p < 0.01).

CONCLUSIONS

The rate of major AEs after lumbar spine surgery is consistent among different sites but the rate of minor AEs appears to vary substantially. The method by which AEs are reported impacts the rate of minor AEs. These data have implications for the detection and reporting of AEs and the design of strategies aimed at mitigating complications.

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Clinical outcomes research in spine surgery: what are appropriate follow-up times?

Presented at the 2018 AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Oliver G. S. Ayling, Tamir Ailon, Greg McIntosh, Alex Soroceanu, Hamilton Hall, Andrew Nataraj, Christopher S. Bailey, Sean Christie, Alexandra Stratton, Henry Ahn, Michael Johnson, Jerome Paquet, Kenneth Thomas, Neil Manson, Y. Raja Rampersaud, and Charles G. Fisher

OBJECTIVE

There has been a generic dictum in spine and musculoskeletal clinical research that a minimum 2-year follow-up is necessary for patient-reported outcomes (PROs) to adequately assess the therapeutic effect of surgery; however, the rationale for this duration is not evidence based. The purpose of this study was to determine the follow-up time necessary to ensure that the effectiveness of a lumbar surgical intervention is adequately captured for three lumbar pathologies and three common PROs.

METHODS

Using the different PROs of pain, physical function, and mental quality of life from the Canadian Spine Outcomes and Research Network (CSORN) prospective database, the authors assessed the time course to the recovery plateau following lumbar spine surgery for lumbar disc herniation, degenerative spondylolisthesis, and spinal stenosis. One-way ANOVA with post hoc testing was used to compare scores on the following standardized PRO measures at baseline and 3, 12, and 24 months postoperatively: Disability Scale (DS), visual analog scale (VAS) for leg and back pain, and SF-12 Mental Component Summary (MCS) and Physical Component Summary (PCS).

RESULTS

Significant differences for all spine pathologies and specific PROs were found with one-way ANOVA (p < 0.0001). The time to plateaued recovery after surgery for lumbar disc herniation (661 patients), lumbar stenosis (913 patients), and lumbar spondylolisthesis (563 patients) followed the same course for the following PRO measures: VAS for back and leg pain, 3 months; DS, 12 months; PCS, 12 months; and MCS, 3 months. Beyond these time points, no further significant improvements in PROs were seen. Patients with degenerative spondylolisthesis or spinal stenosis who had undergone fusion surgery plateaued at 12 months on the DS and PCS, compared to 3 months in those who had not undergone fusion.

CONCLUSIONS

Specific health dimensions follow distinctly different recovery plateaus, indicating that a 2-year postoperative follow-up is not required for all PROs to accurately assess the treatment effect of lumbar spinal surgery. Ultimately, the clinical research question should dictate the follow-up time and the outcome measure utilized; however, there is now evidence to guide the specific duration of follow-up for pain, physical function, and mental quality of life dimensions.

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Oliver G. S. Ayling, Y. Raja Rampersaud, Charlotte Dandurand, Po Hsiang (Shawn) Yuan, Tamir Ailon, Nicolas Dea, Greg McIntosh, Sean D. Christie, Edward Abraham, Christopher S. Bailey, Michael G. Johnson, Jacques Bouchard, Michael H. Weber, Jerome Paquet, Joel Finkelstein, Alexandra Stratton, Hamilton Hall, Neil Manson, Kenneth Thomas, and Charles G. Fisher

OBJECTIVE

Treatment of degenerative lumbar diseases has been shown to be clinically effective with open transforaminal lumbar interbody fusion (O-TLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Despite this, a substantial proportion of patients do not meet minimal clinically important differences (MCIDs) in patient-reported outcomes (PROs). The objectives of this study were to compare the proportions of patients who did not meet MCIDs after O-TLIF and MIS-TLIF and to determine potential clinical factors associated with failure to achieve MCID.

METHODS

The authors performed a retrospective analysis of consecutive patients who underwent O-TLIF or MIS-TLIF for lumbar degenerative disorders and had been prospectively enrolled in the Canadian Spine Outcomes and Research Network. The authors analyzed the Oswestry Disability Index (ODI) scores, physical and mental component summary scores of SF-12, numeric rating scale (NRS) scores for leg and back pain, and EQ-5D scores of the patients in each group who did not meet the MCID of ODI at 2 years postoperatively.

RESULTS

In this study, 38.8% (137 of 353) of patients in the O-TLIF cohort and 41.8% (51 of 122) of patients in the MIS-TLIF cohort did not meet the MCID of ODI at 2 years postoperatively (p = 0.59). Demographic variables and baseline PROs were similar between groups. There were improvements across the PROs of both groups through 2 years, and there were no differences in any PROs between the O-TLIF and MIS-TLIF cohorts. Multivariable logistic regression analysis demonstrated that higher baseline leg pain score (p = 0.017) and a diagnosis of spondylolisthesis (p = 0.0053) or degenerative disc disease (p = 0.022) were associated with achieving the MCID at 2 years after O-TLIF, whereas higher baseline leg pain score was associated with reaching the MCID after MIS-TLIF (p = 0.038).

CONCLUSIONS

Similar proportions of patients failed to reach the MCID of ODI at 2 years after O-TLIF or MIS-TLIF. Higher baseline leg pain score was predictive of achieving the MCID in both cohorts, whereas a diagnosis of spondylolisthesis or degenerative disc disease was predictive of reaching the MCID after O-TLIF. These data provide novel insights for patient counseling and suggest that either MIS-TLIF or O-TLIF does not overcome specific patient factors to mitigate clinical success or failure in terms of the intermediate-term PROs associated with 1- to 2-level lumbar fusion surgical procedures for degenerative pathologies.

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Clayton Inculet, Jennifer C. Urquhart, Parham Rasoulinejad, Hamilton Hall, Charles Fisher, Najmedden Attabib, Kenneth Thomas, Henry Ahn, Michael Johnson, Andrew Glennie, Andrew Nataraj, Sean D. Christie, Alexandra Stratton, Albert Yee, Neil Manson, Jérôme Paquet, Y. Raja Rampersaud, and Christopher S. Bailey

OBJECTIVE

Many studies have utilized a combined cohort of patients with degenerative spondylolisthesis (DS) and isthmic spondylolisthesis (IS) to evaluate indications and outcomes. Intuitively, these are very different populations, and rates, indications, and outcomes may differ. The goal of this study was to compare specific patient characteristics associated with the utilization of a posterior lumbar interbody device between cohorts of patients with DS and IS, as well as to compare rates of interbody device use and patient-rated outcomes at 1 year after surgical treatment.

METHODS

The authors included patients who underwent posterior lumbar interbody fusion or instrumented posterolateral fusion for grade I or II DS or IS and had been enrolled in the Canadian Spine Outcomes and Research Network registry from 2009 to 2016. The outcome measures were score on the Oswestry Disability Index, scores for back pain and leg pain on the numeric rating scale, and mental component summary (MCS) score and physical component summary score on the 12-Item Short-Form Health Survey. Descriptive statistics were used to compare spondylolisthesis groups, logistic regression was used to compare interbody device use, and the chi-square test was used to compare the proportions of patients who achieved a minimal clinically important difference (MCID) at 1 year after surgery.

RESULTS

In total, 119 patients had IS and 339 had DS. Patients with DS were more commonly women, older, less likely to smoke, and more likely to have neurogenic claudication and comorbidities, whereas patients with IS more commonly had radicular pain, neurological deficits, and worse back pain. Spondylolisthesis was more common at the L4–5 level in patients with DS and at the L5–S1 level in patients with IS. Similar proportions of patients had an interbody device (78.6% of patients with DS vs 82.4% of patients with IS, p = 0.429). Among patients with IS, factors associated with interbody device utilization were BMI ≥ 30 kg/m2 and increased baseline leg pain intensity. Factors associated with interbody device utilization in patients with DS were younger age, increased number of total comorbidities, and lower baseline MCS score. For each outcome measure, similar proportions of patients in the surgical treatment and spondylolisthesis groups achieved the MCID at 1 year after surgery.

CONCLUSIONS

Although the demographic and patient characteristics associated with interbody device utilization differed between cohorts, similar proportions of patients attained clinically meaningful improvement at 1 year after surgery.