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Nathan Evaniew, David W. Cadotte, Nicolas Dea, Christopher S. Bailey, Sean D. Christie, Charles G. Fisher, Jerome Paquet, Alex Soroceanu, Kenneth C. Thomas, Y. Raja Rampersaud, Neil A. Manson, Michael Johnson, Andrew Nataraj, Hamilton Hall, Greg McIntosh, and W. Bradley Jacobs

OBJECTIVE

Recently identified prognostic variables among patients undergoing surgery for cervical spondylotic myelopathy (CSM) are limited to two large international data sets. To optimally inform shared clinical decision-making, the authors evaluated which preoperative clinical factors are significantly associated with improvement on the modified Japanese Orthopaedic Association (mJOA) scale by at least the minimum clinically important difference (MCID) 12 months after surgery, among patients from the Canadian Spine Outcomes and Research Network (CSORN).

METHODS

The authors performed an observational cohort study with data that were prospectively collected from CSM patients at 7 centers between 2015 and 2017. Candidate variables were tested using univariable and multiple binomial logistic regression, and multiple sensitivity analyses were performed to test assumptions about the nature of the statistical models. Validated mJOA MCIDs were implemented that varied according to baseline CSM severity.

RESULTS

Among 205 patients with CSM, there were 64 (31%) classified as mild, 86 (42%) as moderate, and 55 (27%) as severe. Overall, 52% of patients achieved MCID and the mean change in mJOA score at 12 months after surgery was 1.7 ± 2.6 points (p < 0.01), but the subgroup of patients with mild CSM did not significantly improve (mean change 0.1 ± 1.9 points, p = 0.8). Univariate analyses failed to identify significant associations between achieving MCID and sex, BMI, living status, education, smoking, disability claims, or number of comorbidities. After adjustment for potential confounders, the odds of achieving MCID were significantly reduced with older age (OR 0.7 per decade, 95% CI 0.5–0.9, p < 0.01) and higher baseline mJOA score (OR 0.8 per point, 95% CI 0.7–0.9, p < 0.01). The effects of symptom duration (OR 1.0 per additional month, 95% CI 0.9–1.0, p = 0.2) and smoking (OR 0.4, 95% CI 0.2–1.0, p = 0.06) were not statistically significant.

CONCLUSIONS

Surgery is effective at halting the progression of functional decline with CSM, and approximately half of all patients achieve the MCID. Data from the CSORN confirmed that older age is independently associated with poorer outcomes, but novel findings include that patients with milder CSM did not experience meaningful improvement, and that symptom duration and smoking were not important. These findings support a nuanced approach to shared decision-making that acknowledges some prognostic uncertainty when weighing the various risks, benefits, and alternatives to surgical treatment.

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Christian Iorio-Morin, Charles G. Fisher, Edward Abraham, Andrew Nataraj, Najmedden Attabib, Jerome Paquet, Thomas Guy Hogan, Christopher S. Bailey, Henry Ahn, Michael Johnson, Eden A. Richardson, Neil Manson, Ken Thomas, Y. Raja Rampersaud, Hamilton Hall, and Nicolas Dea

OBJECTIVE

Lumbar discectomy (LD) is frequently performed to alleviate radicular pain resulting from disc herniation. While this goal is achieved in most patients, improvement in low-back pain (LBP) has been reported inconsistently. The goal of this study was to characterize how LBP evolves following discectomy.

METHODS

The authors performed a retrospective analysis of prospectively collected patient data from the Canadian Spine Outcomes and Research Network (CSORN) registry. Patients who underwent surgery for lumbar disc herniation were eligible for inclusion. The primary outcome was a clinically significant reduction in the back pain numerical rating scale (BPNRS) assessed at 12 months. Binary logistic regression was used to model the relationship between the primary outcome and potential predictors.

RESULTS

There were 557 patients included in the analysis. The chief complaint was radiculopathy in 85%; 55% of patients underwent a minimally invasive procedure. BPNRS improved at 3 months by 48% and this improvement was sustained at all follow-ups. LBP and leg pain improvement were correlated. Clinically significant improvement in BPNRS at 12 months was reported by 64% of patients. Six factors predicted a lack of LBP improvement: female sex, low education level, marriage, not working, low expectations with regard to LBP improvement, and a low BPNRS preoperatively.

CONCLUSIONS

Clinically significant improvement in LBP is observed in the majority of patients after LD. These data should be used to better counsel patients and provide accurate expectations about back pain improvement.

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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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Raphaële Charest-Morin, Christopher S. Bailey, Greg McIntosh, Y. Raja Rampersaud, W. Bradley Jacobs, David W. Cadotte, Jérome Paquet, Hamilton Hall, Michael H. Weber, Michael G. Johnson, Andrew Nataraj, Najmedden Attabib, Neil Manson, Philippe Phan, Sean D. Christie, Kenneth C. Thomas, Charles G. Fisher, and Nicolas Dea

OBJECTIVE

In multilevel posterior cervical instrumented fusion, extension of fusion across the cervicothoracic junction (CTJ) at T1 or T2 has been associated with decreased rates of reoperation and pseudarthrosis but with longer surgical time and increased blood loss. The impact on patient-reported outcomes (PROs) remains unclear. The primary objective was to determine whether extension of fusion through the CTJ influenced PROs at 3, 12, and 24 months after surgery. The secondary objective was to compare the number of patients who reached the minimal clinically important differences (MCIDs) for the PROs, modified Japanese Orthopaedic Association (mJOA) score, operative time, intraoperative blood loss, length of stay, discharge disposition, adverse events (AEs), reoperation within 24 months of surgery, and patient satisfaction.

METHODS

This was a retrospective observational cohort study of prospectively collected multicenter data of patients with degenerative cervical myelopathy. Patients who underwent posterior instrumented fusion of 4 levels or greater (between C2 and T2) between January 2015 and October 2020 and received 24 months of follow-up were included. PROs (scores on the Neck Disability Index [NDI], EQ-5D, physical component summary and mental component summary of SF-12, and numeric rating scale for arm and neck pain) and mJOA scores were compared using ANCOVA and adjusted for baseline differences. Patient demographic characteristics, comorbidities, and surgical details were abstracted. The proportions of patients who reached the MCIDs for these outcomes were compared with the chi-square test. Operative duration, intraoperative blood loss, AEs, reoperation, discharge disposition, length of stay, and satisfaction was compared by using the chi-square test for categorical variables and the independent-samples t-test for continuous variables.

RESULTS

A total of 198 patients were included in this study (101 patients with fusion not crossing the CTJ and 97 with fusion crossing the CTJ). Patients with a construct extending through the CTJ were more likely to be female and have worse baseline NDI scores (p > 0.05). When adjusted for baseline differences, there were no statistically significant differences between the two groups in terms of the PROs and mJOA scores at 3, 12, and 24 months. Surgical duration was longer (p < 0.001) and intraoperative blood loss was greater in the group with fusion extending to the upper thoracic spine (p = 0.013). There were no significant differences between groups in terms of AEs (p > 0.05). Fusion with a construct crossing the CTJ was associated with reoperation (p = 0.04). Satisfaction with surgery was not significantly different between groups. The proportions of patients who reached the MCIDs for the PROs were not statistically different at any time point.

CONCLUSIONS

There were no statistically significant differences in PROs between patients with a posterior construct extending to the upper thoracic spine and those without such extension for as long as 24 months after surgery. The AE profiles were not significantly different, but longer surgical time and increased blood loss were associated with constructs extending across the CTJ.

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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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Lior M. Elkaim, Greg McIntosh, Nicolas Dea, Rodrigo Navarro-Ramirez, W. Bradley Jacobs, David W. Cadotte, Supriya Singh, Sean D. Christie, Aaron Robichaud, Philippe Phan, Jérôme Paquet, Andrew Nataraj, Hamilton Hall, Christopher S. Bailey, Y. Raja Rampersaud, Kenneth Thomas, Neil Manson, Charles Fisher, and Michael H. Weber

OBJECTIVE

Degenerative cervical myelopathy (DCM) is an important public health issue. Surgery is the mainstay of treatment for moderate and severe DCM. Delayed discharge of patients after DCM surgery is associated with increased healthcare costs. There is a paucity of data regarding predictive factors for discharge destination after scheduled surgery for patients with DCM. The purpose of this study was to identify factors predictive of home versus nonhome discharge after DCM surgery.

METHODS

Patients undergoing scheduled DCM surgery who had been enrolled in a prospective DCM substudy of the Canadian Spine Outcomes and Research Network registry between January 2015 and October 2020 were included in this retrospective analysis. Patient data were evaluated to identify potential factors predictive of home discharge after surgery. Logistic regression was used to identify independent factors predictive of home discharge. A multivariable model was then used as a final model.

RESULTS

Overall, 639 patients were included in the initial analysis, 543 (85%) of whom were discharged home. The mean age of the entire cohort was 60 years (SD 11.8 years), with a BMI of 28.9 (SD 5.7). Overall, 61.7% of the patients were female. The mean length of stay was 2.72 days (SD 1.7 days). The final internally validated bootstrapped multivariable model revealed that younger age, higher 9-Item Patient Health Questionnaire score, lower Neck Disability Index scores, fewer operated levels, mJOA scores indicating mild disease, anterior cervical discectomy and fusion procedure, and no perioperative adverse effects were predictive of home discharge.

CONCLUSIONS

Younger age, less neck-related disability, fewer operated levels, more significant depression, less severe myelopathy, anterior cervical discectomy and fusion procedure, and no perioperative adverse effects are predictive of home discharge after surgery for DCM. These factors can help to guide clinical decision-making and optimize postoperative care pathways.

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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.

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Supriya Singh, Tamir Ailon, Greg McIntosh, Nicolas Dea, Jerome Paquet, Edward Abraham, Christopher S. Bailey, Michael H. Weber, Michael G. Johnson, Andrew Nataraj, R. Andrew Glennie, Najmedden Attabib, Adrienne Kelly, Hamilton Hall, Y. Raja Rampersaud, Neil Manson, Philippe Phan, Kenneth Thomas, Charles G. Fisher, and Raphaële Charest-Morin

OBJECTIVE

Time to return to work (RTW) after elective lumbar spine surgery is variable and dependent on many factors including patient, work-related, and surgical factors. The primary objective of this study was to describe the time and rate of RTW after elective lumbar spine surgery. Secondary objectives were to determine predictors of early RTW (< 90 days) and no RTW in this population.

METHODS

A retrospective analysis of prospectively collected data from the multicenter Canadian Spine Outcomes and Research Network (CSORN) surgical registry was performed to identify patients who were employed and underwent elective 1- or 2-level discectomy, laminectomy, and/or fusion procedures between January 2015 and December 2019. The percentage of patients who returned to work and the time to RTW postoperatively were calculated. Predictors of early RTW and not returning to work were determined using a multivariable Cox regression model and a multivariable logistic regression model, respectively.

RESULTS

Of the 1805 employed patients included in this analysis, 71% returned to work at a median of 61 days. The median RTW after a discectomy, laminectomy, or fusion procedure was 51, 46, and 90 days, respectively. Predictors of early RTW included male gender, higher education level (high school or above), higher preoperative Physical Component Summary score, working preoperatively, a nonfusion procedure, and surgery in a western Canadian province (p < 0.05). Patients who were working preoperatively were twice as likely to RTW within 90 days (HR 1.984, 95% CI 1.680–2.344, p < 0.001) than those who were employed but not working. Predictors of not returning to work included symptoms lasting more than 2 years, an increased number of comorbidities, an education level below high school, and an active workers’ compensation claim (p < 0.05). There were fourfold odds of not returning to work for patients who had not been working preoperatively (OR 4.076, 95% CI 3.087–5.383, p < 0.001).

CONCLUSIONS

In the Canadian population, 71% of a preoperatively employed segment returned to work after 1- or 2-level lumbar spine surgery. Most patients who undergo a nonfusion procedure RTW after 6 to 8 weeks, whereas patients undergoing a fusion procedure RTW at 12 weeks. Working preoperatively significantly increased the likelihood of early RTW.

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Supriya Singh, Tamir Ailon, Greg McIntosh, Nicolas Dea, Jerome Paquet, Edward Abraham, Christopher S. Bailey, Michael H. Weber, Michael G. Johnson, Andrew Nataraj, R. Andrew Glennie, Najmedden Attabib, Adrienne Kelly, Hamilton Hall, Y. Raja Rampersaud, Neil Manson, Philippe Phan, Kenneth Thomas, Charles G. Fisher, and Raphaële Charest-Morin

OBJECTIVE

Time to return to work (RTW) after elective lumbar spine surgery is variable and dependent on many factors including patient, work-related, and surgical factors. The primary objective of this study was to describe the time and rate of RTW after elective lumbar spine surgery. Secondary objectives were to determine predictors of early RTW (< 90 days) and no RTW in this population.

METHODS

A retrospective analysis of prospectively collected data from the multicenter Canadian Spine Outcomes and Research Network (CSORN) surgical registry was performed to identify patients who were employed and underwent elective 1- or 2-level discectomy, laminectomy, and/or fusion procedures between January 2015 and December 2019. The percentage of patients who returned to work and the time to RTW postoperatively were calculated. Predictors of early RTW and not returning to work were determined using a multivariable Cox regression model and a multivariable logistic regression model, respectively.

RESULTS

Of the 1805 employed patients included in this analysis, 71% returned to work at a median of 61 days. The median RTW after a discectomy, laminectomy, or fusion procedure was 51, 46, and 90 days, respectively. Predictors of early RTW included male gender, higher education level (high school or above), higher preoperative Physical Component Summary score, working preoperatively, a nonfusion procedure, and surgery in a western Canadian province (p < 0.05). Patients who were working preoperatively were twice as likely to RTW within 90 days (HR 1.984, 95% CI 1.680–2.344, p < 0.001) than those who were employed but not working. Predictors of not returning to work included symptoms lasting more than 2 years, an increased number of comorbidities, an education level below high school, and an active workers’ compensation claim (p < 0.05). There were fourfold odds of not returning to work for patients who had not been working preoperatively (OR 4.076, 95% CI 3.087–5.383, p < 0.001).

CONCLUSIONS

In the Canadian population, 71% of a preoperatively employed segment returned to work after 1- or 2-level lumbar spine surgery. Most patients who undergo a nonfusion procedure RTW after 6 to 8 weeks, whereas patients undergoing a fusion procedure RTW at 12 weeks. Working preoperatively significantly increased the likelihood of early RTW.