Browsing by Author "Massicotte, Eric M"
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Item Open Access A Multicenter Study of the Presentation, Treatment, and Outcomes of Cervical Dural Tears.(Global spine journal, 2017-04) O'Neill, Kevin R; Fehlings, Michael G; Mroz, Thomas E; Smith, Zachary A; Hsu, Wellington K; Kanter, Adam S; Steinmetz, Michael P; Arnold, Paul M; Mummaneni, Praveen V; Chou, Dean; Nassr, Ahmad; Qureshi, Sheeraz A; Cho, Samuel K; Baird, Evan O; Smith, Justin S; Shaffrey, Christopher; Tannoury, Chadi A; Tannoury, Tony; Gokaslan, Ziya L; Gum, Jeffrey L; Hart, Robert A; Isaacs, Robert E; Sasso, Rick C; Bumpass, David B; Bydon, Mohamad; Corriveau, Mark; De Giacomo, Anthony F; Derakhshan, Adeeb; Jobse, Bruce C; Lubelski, Daniel; Lee, Sungho; Massicotte, Eric M; Pace, Jonathan R; Smith, Gabriel A; Than, Khoi D; Riew, K DanielStudy design
Retrospective multicenter case series study.Objective
Because cervical dural tears are rare, most surgeons have limited experience with this complication. A multicenter study was performed to better understand the presentation, treatment, and outcomes following cervical dural tears.Methods
Multiple surgeons from 23 institutions retrospectively identified 21 rare complications that occurred between 2005 and 2011, including unintentional cervical dural tears. Demographic data and surgical history were obtained. Clinical outcomes following surgery were assessed, and any reoperations were recorded. Neck Disability Index (NDI), modified Japanese Orthopaedic Association (mJOA), Nurick classification (NuC), and Short-Form 36 (SF36) scores were recorded at baseline and final follow-up at certain centers. All data were collected, collated, and analyzed by a private research organization.Results
There were 109 cases of cervical dural tears among 18 463 surgeries performed. In 101 cases (93%) there was no clinical sequelae following successful dural tear repair. There were statistical improvements (P < .05) in mJOA and NuC scores, but not NDI or SF36 scores. No specific baseline or operative factors were found to be associated with the occurrence of dural tears. In most cases, no further postoperative treatments of the dural tear were required, while there were 13 patients (12%) that required subsequent treatment of cerebrospinal fluid drainage. Analysis of those requiring further treatments did not identify an optimum treatment strategy for cervical dural tears.Conclusions
In this multicenter study, we report our findings on the largest reported series (n = 109) of cervical dural tears. In a vast majority of cases, no subsequent interventions were required and no clinical sequelae were observed.Item Open Access Anterior versus posterior surgical approaches to treat cervical spondylotic myelopathy: outcomes of the prospective multicenter AOSpine North America CSM study in 264 patients.(Spine, 2013-12) Fehlings, Michael G; Barry, Sean; Kopjar, Branko; Yoon, Sangwook Tim; Arnold, Paul; Massicotte, Eric M; Vaccaro, Alexander; Brodke, Darrel S; Shaffrey, Christopher; Smith, Justin S; Woodard, Eric; Banco, Robert J; Chapman, Jens; Janssen, Michael; Bono, Christopher; Sasso, Rick; Dekutoski, Mark; Gokaslan, Ziya LStudy design
A prospective observational multicenter study.Objective
To help solve the debate regarding whether the anterior or posterior surgical approach is optimal for patients with cervical spondylotic myelopathy (CSM).Summary of background data
The optimal surgical approach to treat CSM remains debated with varying opinions favoring anterior versus posterior surgical approaches. We present an analysis of a prospective observational multicenter study examining outcomes of surgical treatment for CSM.Methods
A total of 278 subjects from 12 sites in North America received anterior/posterior or combined surgery at the discretion of the surgeon. This study focused on subjects who had either anterior or posterior surgery (n = 264, follow-up rate, 87%). Outcome measures included the modified Japanese Orthopedic Assessment scale, the Nurick scale, the Neck Disability Index, and the Short-Form 36 (SF-36) Health Survey version 2 Physical and Mental Component Scores.Results
One hundred and sixty-nine patients were treated anteriorly and 95 underwent posterior surgery. Anterior surgical cases were younger and had less severe myelopathy as assessed by mJOA and Nurick scores. There were no baseline differences in Neck Disability Index or SF-36 between the anterior and posterior cases. Improvement in the mJOA was significantly lower in the anterior group than posterior group (2.47 vs. 3.62, respectively, P < 0.01), although the groups started at different levels of baseline impairment. The extent of improvement in the Nurick Scale, Neck Disability Index, SF-36 version 2 Physical Component Score, and SF-36 version 2 Mental Component Score did not differ between the groups.Conclusion
Patients with CSM show significant improvements in several health-related outcome measures with either anterior or posterior surgery. Importantly, patients treated with anterior techniques were younger, with less severe impairment and more focal pathology. We demonstrate for the first time that, when patient and disease factors are controlled for, anterior and posterior surgical techniques have equivalent efficacy in the treatment of CSM.Level of evidence
3.Item Open Access Cervical radiographical alignment: comprehensive assessment techniques and potential importance in cervical myelopathy.(Spine, 2013-10) Ames, Christopher P; Blondel, Benjamin; Scheer, Justin K; Schwab, Frank J; Le Huec, Jean-Charles; Massicotte, Eric M; Patel, Alpesh A; Traynelis, Vincent C; Kim, Han Jo; Shaffrey, Christopher I; Smith, Justin S; Lafage, VirginieStudy design
Narrative review.Objective
To provide a comprehensive narrative review of cervical alignment parameters, the methods for quantifying cervical alignment, normal cervical alignment values, and how alignment is associated with cervical deformity and myelopathy with discussions of health-related quality of life.Summary of background data
Indications for surgery to correct cervical alignment are not well-defined and there is no set standard to address the amount of correction to be achieved. In addition, classifications of cervical deformity have yet to be fully established and treatment options defined and clarified.Methods
A survey of the cervical spine literature was conducted.Results
New normative cervical alignment values from an asymptomatic volunteer population are introduced, updated methods for quantifying cervical alignment are discussed, and describing the relationship between cervical alignment, disability, and myelopathy are outlined. Specifically, methods used to quantify cervical alignment include cervical lordosis, cervical sagittal vertical axis, and horizontal gaze with the chin-brow vertical angle. Updated methods include T1 slope. Evidence from a few recent studies suggests correlations between radiographical parameters in the cervical spine and health-related quality of life. Analysis of the cervical regional alignment with respect to overall spinal pelvic alignment is emerging and critical. Cervical myelopathy and sagittal alignment of the cervical spine are closely related as cervical deformity can lead to spinal cord compression and tension.Conclusion
Cervical deformity correction should take on a comprehensive approach in assessing global cervical-pelvic relationships and the radiographical parameters that effect health-related quality of life scores are not well-defined. Cervical alignment may be important in assessment and treatment of cervical myelopathy. Future work should concentrate on correlation of cervical alignment parameters to disability scores and myelopathy outcomes. SUMMARY STATEMENTS: STATEMENT 1: Cervical sagittal alignment (cervical SVA and kyphosis) is related to thoracolumbar spinal pelvic alignment and to T1 slope. STATEMENT 2: When significant deformity is clinically or radiographically suspected, regional cervical and relative global spinal alignment should be evaluated preoperatively via standing 3-foot scoliosis X-rays for appropriate operative planning. STATEMENT 3: Cervical sagittal alignment (C2-C7 SVA) is correlated to regional disability, general health scores and to myelopathy severity. STATEMENT 4: When performing decompressive surgery for CSM, consideration should be given to correction of cervical kyphosis and cervical sagittal imbalance (C2-C7 SVA) when present.Item Open Access Early versus delayed decompression for traumatic cervical spinal cord injury: results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS).(PloS one, 2012-01) Fehlings, Michael G; Vaccaro, Alexander; Wilson, Jefferson R; Singh, Anoushka; W Cadotte, David; Harrop, James S; Aarabi, Bizhan; Shaffrey, Christopher; Dvorak, Marcel; Fisher, Charles; Arnold, Paul; Massicotte, Eric M; Lewis, Stephen; Rampersaud, RajaBACKGROUND:There is convincing preclinical evidence that early decompression in the setting of spinal cord injury (SCI) improves neurologic outcomes. However, the effect of early surgical decompression in patients with acute SCI remains uncertain. Our objective was to evaluate the relative effectiveness of early (<24 hours after injury) versus late (≥ 24 hours after injury) decompressive surgery after traumatic cervical SCI. METHODS:We performed a multicenter, international, prospective cohort study (Surgical Timing In Acute Spinal Cord Injury Study: STASCIS) in adults aged 16-80 with cervical SCI. Enrolment occurred between 2002 and 2009 at 6 North American centers. The primary outcome was ordinal change in ASIA Impairment Scale (AIS) grade at 6 months follow-up. Secondary outcomes included assessments of complications rates and mortality. FINDINGS:A total of 313 patients with acute cervical SCI were enrolled. Of these, 182 underwent early surgery, at a mean of 14.2(± 5.4) hours, with the remaining 131 having late surgery, at a mean of 48.3(± 29.3) hours. Of the 222 patients with follow-up available at 6 months post injury, 19.8% of patients undergoing early surgery showed a ≥ 2 grade improvement in AIS compared to 8.8% in the late decompression group (OR = 2.57, 95% CI:1.11,5.97). In the multivariate analysis, adjusted for preoperative neurological status and steroid administration, the odds of at least a 2 grade AIS improvement were 2.8 times higher amongst those who underwent early surgery as compared to those who underwent late surgery (OR = 2.83, 95% CI:1.10,7.28). During the 30 day post injury period, there was 1 mortality in both of the surgical groups. Complications occurred in 24.2% of early surgery patients and 30.5% of late surgery patients (p = 0.21). CONCLUSION:Decompression prior to 24 hours after SCI can be performed safely and is associated with improved neurologic outcome, defined as at least a 2 grade AIS improvement at 6 months follow-up.Item Open Access Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study.(The Journal of bone and joint surgery. American volume, 2013-09) Fehlings, Michael G; Wilson, Jefferson R; Kopjar, Branko; Yoon, Sangwook Tim; Arnold, Paul M; Massicotte, Eric M; Vaccaro, Alexander R; Brodke, Darrel S; Shaffrey, Christopher I; Smith, Justin S; Woodard, Eric J; Banco, Robert J; Chapman, Jens R; Janssen, Michael E; Bono, Christopher M; Sasso, Rick C; Dekutoski, Mark B; Gokaslan, Ziya LBackground
Cervical spondylotic myelopathy is the leading cause of spinal cord dysfunction worldwide. The objective of this study was to evaluate the impact of surgical decompression on functional, quality-of-life, and disability outcomes at one year after surgery in a large cohort of patients with this condition.Methods
Adult patients with symptomatic cervical spondylotic myelopathy and magnetic resonance imaging evidence of spinal cord compression were enrolled at twelve North American centers from 2005 to 2007. At enrollment, the myelopathy was categorized as mild (modified Japanese Orthopaedic Association [mJOA] score ≥ 15), moderate (mJOA = 12 to 14), or severe (mJOA < 12). Patients were followed prospectively for one year, at which point the outcomes of interest included the mJOA score, Nurick grade, Neck Disability Index (NDI), and Short Form-36 version 2 (SF-36v2). All outcomes at one year were compared with the preoperative values with use of univariate paired statistics. Outcomes were also compared among the severity classes with use of one-way analysis of variance. Finally, a multivariate analysis that adjusted for baseline differences among the severity groups was performed. Treatment-related complication data were collected and the overall complication rate was calculated.Results
Eighty-five (30.6%) of the 278 enrolled patients had mild cervical spondylotic myelopathy, 110 (39.6%) had moderate disease, and 83 (29.9%) had severe disease preoperatively. One-year follow-up data were available for 222 (85.4%) of 260 patients. There was a significant improvement from baseline to one year postoperatively (p < 0.05) in the mJOA score, Nurick grade, NDI score, and all SF-36v2 health dimensions (including the mental and physical health composite scores) except general health. With the exception of the change in the mJOA, the degree of improvement did not depend on the severity of the preoperative symptoms. These results remained unchanged after adjusting for relevant confounders in the multivariate analysis. Fifty-two patients experienced complications (prevalence, 18.7%), with no significant differences among the severity groups.Conclusions
Surgical decompression for the treatment of cervical spondylotic myelopathy was associated with improvement in functional, disability-related, and quality-of-life outcomes at one year of follow-up for all disease severity categories. Furthermore, complication rates observed in the study were commensurate with those in previously reported cervical spondylotic myelopathy series.Item Open Access Impact of dynamic alignment, motion, and center of rotation on myelopathy grade and regional disability in cervical spondylotic myelopathy.(Journal of neurosurgery. Spine, 2015-12) Liu, Shian; Lafage, Renaud; Smith, Justin S; Protopsaltis, Themistocles S; Lafage, Virginie C; Challier, Vincent; Shaffrey, Christopher I; Radcliff, Kris; Arnold, Paul M; Chapman, Jens R; Schwab, Frank J; Massicotte, Eric M; Yoon, S Tim; Fehlings, Michael G; Ames, Christopher PObject
Cervical stenosis is a defining feature of cervical spondylotic myelopathy (CSM). Matsunaga et al. proposed that elements of stenosis are both static and dynamic, where the dynamic elements magnify the canal deformation of the static state. For the current study, the authors hypothesized that dynamic changes may be associated with myelopathy severity and neck disability. This goal of this study was to present novel methods of dynamic motion analysis in CSM.Methods
A post hoc analysis was performed of a prospective, multicenter database of patients with CSM from the AOSpine North American study. One hundred ten patients (34%) met inclusion criteria, which were symptomatic CSM, age over 18 years, baseline flexion/extension radiographs, and health-related quality of life (HRQOL) questionnaires (modified Japanese Orthopaedic Association [mJOA] score, Neck Disability Index [NDI], the 36-Item Short Form Health Survey Physical Component Score [SF-36 PCS], and Nurick grade). The mean age was 56.9 ± 12 years, and 42% of patients were women (n = 46). Correlations with HRQOL measures were analyzed for regional (cervical lordosis and cervical sagittal vertical axis) and focal parameters (kyphosis and spondylolisthesis between adjacent vertebrae) in flexion and extension. Baseline dynamic parameters (flexion/extension cone relative to a fixed C-7, center of rotation [COR], and range of motion arc relative to the COR) were also analyzed for correlations with HRQOL measures.Results
At baseline, the mean HRQOL measures demonstrated disability and the mean radiographic parameters demonstrated sagittal malalignment. Among regional parameters, there was a significant correlation between decreased neck flexion (increased C2-7 angle in flexion) and worse Nurick grade (R = 0.189, p = 0.048), with no significant correlations in extension. Focal parameters, including increased C-7 sagittal translation overT-1 (slip), were significantly correlated with greater myelopathy severity (mJOA score, Flexion R = -0.377, p = 0.003; mJOA score, Extension R = -0.261, p = 0.027). Sagittal slip at C-2 and C-4 also correlated with worse HRQOL measures. Reduced flexion/extension motion cones, a more posterior COR, and smaller range of motion correlated with worse general health SF-36 PCS and Nurick grade.Conclusions
Dynamic motion analysis may play an important role in understanding CSM. Focal parameters demonstrated a significant correlation with worse HRQOL measures, especially increased C-7 sagittal slip in flexion and extension. Novel methods of motion analysis demonstrating reduced motion cones correlated with worse myelopathy grades. More posterior COR and smaller range of motion were both correlated with worse general health scores (SF-36 PCS and Nurick grade). To our knowledge, this is the first study to demonstrate correlation of dynamic motion and listhesis with disability and myelopathy in CSM.Item Open Access In response.(Spine, 2014-07) Fehlings, Michael G; Barry, Sean; Kopjar, Branko; Yoon, Sangwook Tim; Arnold, Paul; Massicotte, Eric M; Vaccaro, Alexander; Brodke, Darrel S; Shaffrey, Christopher; Smith, Justin S; Woodard, Eric; Banco, Robert J; Chapman, Jens; Janssen, Michael; Bono, Christopher; Sasso, Rick; Dekutoski, Mark; Gokaslan, Ziya LItem Open Access Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM).(The spine journal : official journal of the North American Spine Society, 2014-01) Arnold, Paul M; Fehlings, Michael G; Kopjar, Branko; Yoon, Sangwook Tim; Massicotte, Eric M; Vaccaro, Alexander R; Brodke, Darrel S; Shaffrey, Christopher I; Smith, Justin S; Woodard, Eric J; Banco, Robert J; Chapman, Jens R; Janssen, Michael E; Bono, Christopher M; Sasso, Rick C; Dekutoski, Mark B; Gokaslan, Ziya LBackground context
Cervical spondylotic myelopathy (CSM) is a chronic spinal cord disease and can lead to progressive or stepwise neurologic decline. Several factors may influence this process, including extent of spinal cord compression, duration of symptoms, and medical comorbidities. Diabetes is a systemic disease that can impact multiple organ systems, including the central and peripheral nervous systems. There has been little information regarding the effect of diabetes on patients with coexistent CSM.Purpose
To provide empirical data regarding the effect of diabetes on treatment outcomes in patients who underwent surgical decompression for coexistent CSM.Study design/setting
Large prospective multicenter cohort study of patients with and without diabetes who underwent decompressive surgery for CSM.Patient sample
Two hundred thirty-six patients without and 42 patients with diabetes were enrolled. Of these, 37 were mild cases and five were moderate cases. Four required insulin. There were no severe cases associated with end-organ damage.Outcome measures
Self-report measures include Neck Disability Index and version 2 of 36-Item Short Form Health Survey (SF-36v2), and functional measures include modified Japanese Orthopedic Association (mJOA) score and Nurick grade.Methods
We compared presurgery symptoms and treatment outcomes between patients with and without diabetes using univariate and multivariate models, adjusting for demographics and comorbidities.Results
Diabetic patients were older, less likely to smoke, and more likely to be on social security disability insurance. Patients with diabetes presented with a worse Nurick grade, but there were no differences in mJOA and SF-36v2 at presentation. Overall, there was a significant improvement in all outcome parameters at 12 and 24 months. There was no difference in the level of improvement between the patients with and without diabetes, except in the SF-36v2 Physical Functioning, in which diabetic patients experienced significantly less improvement. There were no differences in surgical complication rates between diabetic patients and nondiabetic patients.Conclusions
Except for a worse Nurick grade, diabetes does not seem to affect severity of symptoms at presentation for surgery. More importantly, with the exception of the SF-36v2 Physical Functioning scores, outcomes of surgical treatment are similar in patients with diabetes and without diabetes. Surgical decompression is effective and should be offered to patients with diabetes who have symptomatic CSM and are appropriate surgical candidates.Item Open Access Novel Method Using Baseline Normalization and Area Under the Curve to Evaluate Differences in Outcome Between Treatment Groups and Application to Patients With Cervical Spondylotic Myelopathy Undergoing Anterior Versus Posterior Surgery.(Spine, 2015-12) Liu, Shian; Tetreault, Lindsay; Fehlings, Michael G; Challier, Vincent; Smith, Justin S; Shaffrey, Christopher I; Arnold, Paul M; Scheer, Justin K; Chapman, Jens R; Kopjar, Branko; Protopsaltis, Themistocles S; Lafage, Virginie; Schwab, Frank; Massicotte, Eric M; Yoon, Sangwook T; Ames, Christopher PRetrospective review of a prospective database.To describe a novel method that uses baseline normalization and area under the curve (AUC) to compare surgical outcomes between patients surgically treated anteriorly versus posteriorly for cervical spondylotic myelopathy (CSM).It is important to control for baseline characteristics, especially disease severity, when evaluating differences in outcomes between 2 treatment groups. However, current methods of reporting outcomes are limited perhaps diminish the health impact of the entire postoperative recovery experience.In the prospective, multicenter AO Spine North America CSM database, 147 patients had complete modified Japanese Orthopaedic Association (mJOA) data at baseline and at 6-, 12-, and 24-months postoperatively and were either treated anteriorly (n = 94) or posteriorly (n = 53). Each patient's follow-up mJOA scores were normalized by dividing them by the patient's baseline value. A graph was then plotted with the time point on the x-axis and the normalized score or "recovery index" on the y-axis. The AUC was calculated and then compared between the anterior and posterior surgical approach groups.The non-normalized recovery profile of the anterior group was better than that of the posterior group, as the patients treated anteriorly had less functional impairment at baseline. After normalization, patients in the anterior and posterior group had similar recovery indices and AUCs at 6-months following surgery. At 24-months, patients treated posteriorly had a significantly higher recovery index (1.32) and a larger AUC (16.3) than those treated anteriorly (1.11, 14.5, P = 0.004 and P = 0.006, respectively).This is the first study to apply AUC analysis to patients with CSM. In surgical patients with CSM, those treated anteriorly achieved a higher mJOA score at all time points than those treated posteriorly. The recovery indices, however, were not significantly different between approach groups at 6 months.3.Item Open Access Perioperative and delayed complications associated with the surgical treatment of cervical spondylotic myelopathy based on 302 patients from the AOSpine North America Cervical Spondylotic Myelopathy Study.(Journal of neurosurgery. Spine, 2012-05) Fehlings, Michael G; Smith, Justin S; Kopjar, Branko; Arnold, Paul M; Yoon, S Tim; Vaccaro, Alexander R; Brodke, Darrel S; Janssen, Michael E; Chapman, Jens R; Sasso, Rick C; Woodard, Eric J; Banco, Robert J; Massicotte, Eric M; Dekutoski, Mark B; Gokaslan, Ziya L; Bono, Christopher M; Shaffrey, Christopher IObject
Rates of complications associated with the surgical treatment of cervical spondylotic myelopathy (CSM) are not clear. Appreciating these risks is important for patient counseling and quality improvement. The authors sought to assess the rates of and risk factors associated with perioperative and delayed complications associated with the surgical treatment of CSM.Methods
Data from the AOSpine North America Cervical Spondylotic Myelopathy Study, a prospective, multicenter study, were analyzed. Outcomes data, including adverse events, were collected in a standardized manner and externally monitored. Rates of perioperative complications (within 30 days of surgery) and delayed complications (31 days to 2 years following surgery) were tabulated and stratified based on clinical factors.Results
The study enrolled 302 patients (mean age 57 years, range 29-86) years. Of 332 reported adverse events, 73 were classified as perioperative complications (25 major and 48 minor) in 47 patients (overall perioperative complication rate of 15.6%). The most common perioperative complications included minor cardiopulmonary events (3.0%), dysphagia (3.0%), and superficial wound infection (2.3%). Perioperative worsening of myelopathy was reported in 4 patients (1.3%). Based on 275 patients who completed 2 years of follow-up, there were 14 delayed complications (8 minor, 6 major) in 12 patients, for an overall delayed complication rate of 4.4%. Of patients treated with anterior-only (n = 176), posterior-only (n = 107), and combined anterior-posterior (n = 19) procedures, 11%, 19%, and 37%, respectively, had 1 or more perioperative complications. Compared with anterior-only approaches, posterior-only approaches had a higher rate of wound infection (0.6% vs 4.7%, p = 0.030). Dysphagia was more common with combined anterior-posterior procedures (21.1%) compared with anterior-only procedures (2.3%) or posterior-only procedures (0.9%) (p < 0.001). The incidence of C-5 radiculopathy was not associated with the surgical approach (p = 0.8). The occurrence of perioperative complications was associated with increased age (p = 0.006), combined anterior-posterior procedures (p = 0.016), increased operative time (p = 0.009), and increased operative blood loss (p = 0.005), but it was not associated with comorbidity score, body mass index, modified Japanese Orthopaedic Association score, smoking status, anterior-only versus posterior-only approach, or specific procedures. Multivariate analysis of factors associated with minor or major complications identified age (OR 1.029, 95% CI 1.002-1.057, p = 0.035) and operative time (OR 1.005, 95% CI 1.002-1.008, p = 0.001). Multivariate analysis of factors associated with major complications identified age (OR 1.054, 95% CI 1.015-1.094, p = 0.006) and combined anterior-posterior procedures (OR 5.297, 95% CI 1.626-17.256, p = 0.006).Conclusions
For the surgical treatment of CSM, the vast majority of complications were treatable and without long-term impact. Multivariate factors associated with an increased risk of complications include greater age, increased operative time, and use of combined anterior-posterior procedures.Item Open Access Rare Complications of Cervical Spine Surgery: Pseudomeningocoele.(Global spine journal, 2017-04) Ailon, Tamir; Smith, Justin S; Nassr, Ahmad; Smith, Zachary A; Hsu, Wellington K; Fehlings, Michael G; Fish, David E; Wang, Jeffrey C; Hilibrand, Alan S; Mummaneni, Praveen V; Chou, Dean; Sasso, Rick C; Traynelis, Vincent C; Arnold, Paul M; Mroz, Thomas E; Buser, Zorica; Lord, Elizabeth L; Massicotte, Eric M; Sebastian, Arjun S; Than, Khoi D; Steinmetz, Michael P; Smith, Gabriel A; Pace, Jonathan; Corriveau, Mark; Lee, Sungho; Riew, K Daniel; Shaffrey, ChristopherThis study was a retrospective, multicenter cohort study.Rare complications of cervical spine surgery are inherently difficult to investigate. Pseudomeningocoele (PMC), an abnormal collection of cerebrospinal fluid that communicates with the subarachnoid space, is one such complication. In order to evaluate and better understand the incidence, presentation, treatment, and outcome of PMC following cervical spine surgery, we conducted a multicenter study to pool our collective experience.This study was a retrospective, multicenter cohort study of patients who underwent cervical spine surgery at any level(s) from C2 to C7, inclusive; were over 18 years of age; and experienced a postoperative PMC.Thirteen patients (0.08%) developed a postoperative PMC, 6 (46.2%) of whom were female. They had an average age of 48.2 years and stayed in hospital a mean of 11.2 days. Three patients were current smokers, 3 previous smokers, 5 had never smoked, and 2 had unknown smoking status. The majority, 10 (76.9%), were associated with posterior surgery, whereas 3 (23.1%) occurred after an anterior procedure. Myelopathy was the most common indication for operations that were complicated by PMC (46%). Seven patients (53%) required a surgical procedure to address the PMC, whereas the remaining 6 were treated conservatively. All PMCs ultimately resolved or were successfully treated with no residual effects.PMC is a rare complication of cervical surgery with an incidence of less than 0.1%. They prolong hospital stay. PMCs occurred more frequently in association with posterior approaches. Approximately half of PMCs required surgery and all ultimately resolved without residual neurologic or other long-term effects.Item Open Access Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial.(JAMA network open, 2024-06) Fehlings, Michael G; Pedro, Karlo M; Alvi, Mohammed Ali; Badhiwala, Jetan H; Ahn, Henry; Farhadi, H Francis; Shaffrey, Christopher I; Nassr, Ahmad; Mummaneni, Praveen; Arnold, Paul M; Jacobs, W Bradley; Riew, K Daniel; Kelly, Michael; Brodke, Darrel S; Vaccaro, Alexander R; Hilibrand, Alan S; Wilson, Jason; Harrop, James S; Yoon, S Tim; Kim, Kee D; Fourney, Daryl R; Santaguida, Carlo; Massicotte, Eric M; Huang, PengImportance
The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery.Objective
To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM.Design, setting, and participants
This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023.Intervention
Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery.Main outcomes and measures
The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE).Results
Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007).Conclusions and relevance
In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.Item Open Access Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.(The Lancet. Neurology, 2021-02) Fehlings, Michael G; Badhiwala, Jetan H; Ahn, Henry; Farhadi, H Francis; Shaffrey, Christopher I; Nassr, Ahmad; Mummaneni, Praveen; Arnold, Paul M; Jacobs, W Bradley; Riew, K Daniel; Kelly, Michael; Brodke, Darrel S; Vaccaro, Alexander R; Hilibrand, Alan S; Wilson, Jason; Harrop, James S; Yoon, S Tim; Kim, Kee D; Fourney, Daryl R; Santaguida, Carlo; Massicotte, Eric M; Kopjar, BrankoBackground
Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy.Methods
This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18-80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8-14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov, NCT01257828.Findings
From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference -0·38 points (-0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications.Interpretation
In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study.Funding
AOSpine North America.Item Open Access The impact of facet dislocation on clinical outcomes after cervical spinal cord injury: results of a multicenter North American prospective cohort study.(Spine, 2013-01) Wilson, Jefferson R; Vaccaro, Alexander; Harrop, James S; Aarabi, Bizhan; Shaffrey, Christopher; Dvorak, Marcel; Fisher, Charles; Arnold, Paul; Massicotte, Eric M; Lewis, Stephen; Rampersaud, Raja; Okonkwo, David O; Fehlings, Michael GStudy design
A multicenter prospective cohort study.Objective
To define differences in baseline characteristics and long-term clinical outcomes in patients with cervical spinal cord injury (SCI) with and without facet dislocation (FD).Summary of background data
Reports of dramatic neurological improvement in patients with FD and cervical SCI, treated with rapid reduction have led to the hypothesis that this represents a subgroup of patients with significant recovery potential. However, without a large systematic comparative analysis, this hypothesis remains untested.Methods
Patients were classified into FD and non-FD groups based on imaging investigations at admission. The primary outcome was change in American Spinal Injury Association (ASIA) motor score (AMS) at 1-year follow-up. Secondary outcome measures included ASIA impairment scale (AIS) grade conversion and functional independence measure score at 1-year postinjury, as well as length of acute hospitalization. Baseline characteristics and long-term outcomes were also compared for patients with unilateral and bilateral FD.Results
Of 421 patients who enrolled, 135 (32.1%) had FD and 286 (67.9%) had no FD. Patients in the FD group presented with a significantly worse AIS grade and higher energy injury mechanisms (P < 0.01). Patients with bilateral FD had a greater severity of baseline neurological deficit compared with those with unilateral FD, measured by AIS grade and AMS. The mean length of acute hospitalization was 41.2 days among patients with FD and 30 days among patients without FD (P = 0.04). At 1-year follow-up, patients with FD experienced a mean AMS improvement of 18.0 points, whereas patients without FD experienced an improvement of 27.9 points (P < 0.01). In the adjusted analysis, patients with FD continued to demonstrate less AMS recovery compared with the patients without FD (P = 0.04).Conclusion
Compared with patients without FD, cervical SCI patients with FD tended to present with a more severe degree of initial injury and displayed less potential for motor recovery at 1-year follow-up.