Publications by authors named "James Harrop"

327 Publications

The Impact of Incorporating Evidence-based Guidelines for Lumbar Fusion Surgery in Neurosurgical Resident Education.

World Neurosurg 2021 Jul 19. Epub 2021 Jul 19.

Department of Neurosurgery, Thomas Jefferson University and Jefferson Hospital for Neuroscience, Philadelphia, Pennsylvania.

Background: Instrumented fusion procedures are essential in the treatment of degenerative lumbar spine disease to alleviate pain and improve neurologic function, but are being performed with increasing incidence and variability.

Objective: We implemented a training module for neurosurgery residents that is based on evidence-based criteria for lumbar fusion surgery and measured its effectiveness in the residents' decision making regarding whether patients should or should not undergo instrumented fusion.

Methods: The study design is a pretest versus posttest experiment conducted from September 2019 until July 2020 to measure improvement after formalized instruction on evidence-based guidelines. Neurosurgery resident physicians of all training levels at our institution participated and a test was administered at the beginning of each academic year. The highest possible score was 18 points in each pretest and posttest.

Results: The participation rate is 79.2% (19/24). There was a general trend of test score improvement across all levels of training with a greater degree of change for those with a lower compared to higher pretest scores, indicating a possible ceiling effect. Paired t-test demonstrated an overall mean score increase of 2 points (p<0.0001), equivalent to an 11.11%-increase (p<0.0001). Stratified by training group, the mean absolute change in test score was 2 (p=0.0217), 1.67 (p=0.0108), and 2.25 (p=0.0173) points for the junior, midlevel, and senior training groups, respectively.

Conclusions: The authors demonstrate that incorporating a targeted evidence-based learning module for lumbar spine fusion surgery can improve neurosurgery residents' clinical decision-making toward a more uniform practice supported by published data.
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http://dx.doi.org/10.1016/j.wneu.2021.07.045DOI Listing
July 2021

Graph theoretical structural connectome analysis of the brain in patients with chronic spinal cord injury: preliminary investigation.

Spinal Cord Ser Cases 2021 Jul 17;7(1):60. Epub 2021 Jul 17.

Jefferson Integrated Magnetic Resonance Imaging Center, Department of Radiology, Thomas Jefferson University, Philadelphia, PA, USA.

Study Design: Retrospective study.

Objectives: We aimed to characterize the convergent disruptions of the structural connectivity based on network modeling technique (i.e., graph theory) to identify significant changes in network organization/reorganization between uninjured and chronic spinal cord injury (SCI) participants.

Setting: USA.

Methods: Ten adult participants including 4 with chronic SCI and 6 uninjured were scanned using a multi-shell diffusion imaging on a 3.0 T MR scanner. Whole brain structural connectivity matrix was estimated by performing the quantification of the number of white matter fibers (called edges) connecting each possible pair of brain region (called nodes). Brain regions were defined according to Desikan-Killiany cortical atlas. Using connectivity matrix, connectivity strength as well as six different graph theoretical measurements were computed for each participant. They include: (1) global efficiency; (2) local efficiency; (3) degree; (4) betweenness centrality; (5) average shortest length and (6) clustering coefficient. Finally network based statistics was applied to extract nodes/connections with significant differences between groups (uninjured vs SCI).

Results: The SCI group showed significant decreases in betweenness centrality in the left precentral gyrus (T-score=2.98, p value=0.02), and the right caudal middle frontal gyrus (score = 2.35, p value=0.047). It also showed significant decrease in left transverse temporal gyrus (T-score=2.36, p value=0.046) in clustering coefficient. In addition, altered regions in the occipital and parietal lobe were also identified.

Conclusion: These results suggest that not only local but also global alterations of the white matter occur after SCI. The proposed modeling technique has the potential to serve as a screening tool to identify any areas of the brain affected after SCI.
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http://dx.doi.org/10.1038/s41394-021-00424-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8286254PMC
July 2021

Impact of inhalational anesthetic agents on the baseline monitorability of motor evoked potentials (MEPs) during spine surgery: A review of 22,755 cervical and lumbar procedures.

Spine J 2021 Jul 15. Epub 2021 Jul 15.

SpecialtyCare, Brentwood, TN.

Background Context: During spine surgery, motor evoked potentials (MEPs) are often utilized to monitor both spinal cord function and spinal nerve root or plexus function. While there are reports evaluating the impact of anesthesia on the reliability of MEPs to monitor spinal cord function, less is known about the impact of anesthetics on the ability of MEPs to monitor spinal nerve root and plexus function.

Purpose: To compare the baseline monitorability and amplitude of MEPs during cervical and lumbar procedures between two cohorts based on the maintenance anesthetic regimen: a total intravenous anesthesia (TIVA) versus a regimen balanced with volatile inhalational and intravenous agents.

Study Design/setting: Baseline MEP data from a total of 16,559 cervical and 6,196 lumbar extradural spine procedures utilizing multimodality intraoperative neuromonitoring (IONM) including MEPs between January 2017 and March 2020 were obtained from a multi-institutional database. Two cohorts for each region of spine surgery were delineated based on the anesthetic regimen: a TIVA cohort and a Balanced anesthesia cohort.

Patient Sample: Age 18 and older OUTCOME MEASURES: Percent monitorability and amplitudes of baseline MEPs.

Methods: The baseline monitorability of each muscle MEP was evaluated by the IONM team in real-time and recorded in the patient's electronic medical record. The relation between anesthetic regimen and baseline monitorability was estimated using mixed effects logistic regression, with distinct models for cervical and lumbar procedures. Subsets of cervical and lumbar procedures from each anesthesia cohort in which all MEPs were deemed monitorable were randomly selected and the average peak-to-trough amplitude of each muscle MEP was retrospectively measured. Mixed-effects linear regression models were estimated (one each for cervical and lumbar procedures) to assess possible differences in average amplitude associated with anesthesia regimen.

Results: At the time of surgery, baseline MEPs were reported monitorable from all targeted muscles in 86.8% and 83.0% of cervical and lumbar procedures, respectively, for the TIVA cohort, but were reported monitorable in just 59.3% and 61.0% of cervical and lumbar procedures, respectively, in the Balanced cohort, yielding disparities of 27.5% and 22.0%, respectively. The model-adjusted monitorability disparity between cohorts for a given muscle MEP ranged from 0.2% -16.6% but was smallest for distal intrinsic hand and foot muscle MEPs (0.2%-1.1%) and was largest for proximal muscle MEPs (deltoid: 10.8%, biceps brachii: 8.8%, triceps: 13.0%, quadriceps: 16.6%, gastrocnemius: 7.8%, and tibialis anterior: 3.7%) where the monitorability was significantly decreased in the Balanced cohort relative to the TIVA cohort (P < 0.0001). Relative to the TIVA cohort, the model-adjusted amplitude of an MEP in the Balanced cohort was smaller for all muscles measured, ranging from 27.5%-78.0% smaller. Relative to the TIVA cohort, the model-adjusted amplitude of an MEP was significantly decreased (P <0.01) in the Balanced cohort for the most proximal muscles (Percent smaller: deltoid: 74.3%, biceps: 78.0%, triceps: 54.9.0%, quadriceps: 54.8%).

Conclusions: TIVA is the preferred anesthetic regimen for optimizing MEP monitoring during spine surgery. Inhalational agents significantly decrease MEP monitorability and amplitudes for most muscles, and this effect is especially pronounced for proximal limb muscles such as the deltoid, biceps, triceps, and quadriceps.
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http://dx.doi.org/10.1016/j.spinee.2021.07.002DOI Listing
July 2021

Are Lumbar Fusion Guidelines Followed? A Survey of North American Spine Surgeons.

Neurospine 2021 Jun 30;18(2):389-396. Epub 2021 Jun 30.

Department of Neurosurgery, Thomas Jefferson University and Jefferson Hospital for Neuroscience, Philadelphia, PA, USA.

Objective: To evaluate the use of guidelines for lumbar spine fusions among spine surgeons in North America.

Methods: An anonymous survey was electronically sent to all AO Spine North America members. Survey respondents were asked to indicate their opinion surrounding the suitability of instrumented fusion in a variety of clinical scenarios. Fusion indications in accordance with North America Spine Society (NASS) guidelines for lumbar fusion were considered NASS-concordant answers. Respondents were considered to have a NASS-concordant approach if ≥ 70% (13 of 18) of their answers were NASS-concordant answers. Comparisons were performed using bivariable statistics.

Results: A total of 105 responses were entered with complete data available on 70. Sixty percent of the respondents (n = 42) were considered compliant with NASS guidelines. NASS-discordant responses did not differ between surgeons who stated that they include the NASS guidelines in their decision-making algorithm (5.10 ± 1.96) and those that did not (4.68 ± 2.09) (p = 0.395). The greatest number of NASS-discordant answers in the United States. was in the South (5.75 ± 2.09), with the lowest number in the Northeast (3.84 ± 1.70) (p < 0.01). For 5 survey items, rates of NASS-discordant answers were ≥ 40%, with the greatest number of NASS-discordant responses observed in relation to indications for fusion in spinal deformity (80%). Spine surgeons utilizing a NASS-concordant approach had a significant lower number of NASS-discordant answers for synovial cysts (p = 0.03), axial low back pain (p < 0.01), adjacent level disease (p < 0.01), recurrent stenosis (p < 0.01), recurrent disc herniation (p = 0.01), and foraminal stenosis (p < 0.01).

Conclusion: This study serves an important role in clarifying the rates of uptake of clinical practice guidelines in spine surgery as well as to identify barriers to their implementation.
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http://dx.doi.org/10.14245/ns.2142136.068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8255757PMC
June 2021

The development of lived experience-centered word clouds to support research uncertainty gathering in degenerative cervical myelopathy: results from an engagement process and protocol for their evaluation, via a nested randomized controlled trial.

Trials 2021 Jun 25;22(1):415. Epub 2021 Jun 25.

Academic Neurosurgery Unit & Anne McLaren Laboratory of Regenerative Medicine, Department of Clinical Neurosurgery, University of Cambridge, Cambridge, UK.

Objectives: AO Spine REsearch objectives and Common Data Elements for Degenerative Cervical Myelopathy [RECODE-DCM] is a multi-stakeholder consensus process aiming to promote research efficiency in DCM. It aims to establish the top 10 research uncertainties, through a James Lind Alliance Priority Setting Partnership [PSP]. Through a consensus process, research questions are generated and ranked. The inclusion of people with cervical myelopathy [PwCM] is central to the process. We hypothesized that presenting PwCM experience through word cloud generation would stimulate other key stakeholders to generate research questions better aligned with PwCM needs. This protocol outlines our plans to evaluate this as a nested methodological study within our PSP.

Methods: An online poll asked PwCM to submit and vote on words associated with aspects of DCM. After review, a refined word list was re-polled for voting and word submission. Word clouds were generated and an implementation plan for AO Spine RECODE-DCM PSP surveys was subsequently developed.

Results: Seventy-nine terms were submitted after the first poll. Eighty-seven refined words were then re-polled (which added a further 39 words). Four word clouds were generated under the categories of diagnosis, management, long-term effects, and other. A 1:1 block randomization protocol to assess word cloud impact on the number and relevance of PSP research questions was generated.

Conclusions: We have shown it is feasible to work with PwCM to generate a tool for the AO Spine RECODE-DCM nested methodological study. Once the survey stage is completed, we will be able to evaluate the impact of the word clouds. Further research will be needed to assess the value of any impact in terms of stimulating a more creative research agenda.
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http://dx.doi.org/10.1186/s13063-021-05349-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8235822PMC
June 2021

Cervical fusion for treatment of degenerative conditions: Development of appropriate use criteria.

Spine J 2021 Jun 1. Epub 2021 Jun 1.

Department of Neurosurgery, Lahey Hospital & Medical Center, 41 Mall Road Charles A, Tufts University School of Medicine, Burlington, MA 01805-0105, USA.

Background Context: High quality evidence is difficult to generate, leaving substantial knowledge gaps in the treatment of spinal conditions. Appropriate use criteria (AUC) are a means of determining appropriate recommendations when high quality evidence is lacking.

Purpose: Define appropriate use criteria (AUC) of cervical fusion for treatment of degenerative conditions of the cervical spine.

Study Design/setting: Appropriate use criteria for cervical fusion were developed using the RAND/UCLA appropriateness methodology. Following development of clinical guidelines and scenario writing, a one-day workshop was held with a multidisciplinary group of 14 raters, all considered thought leaders in their respective fields, to determine final ratings for cervical fusion appropriateness for various clinical situations.

Outcome Measures: Final rating for cervical fusion recommendation as either "Appropriate," "Uncertain" or "Rarely Appropriate" based on the median final rating among the raters.

Methods: Inclusion criteria for scenarios included patients aged 18 to 80 with degenerative conditions of the cervical spine. Key modifiers were defined and combined to develop a matrix of clinical scenarios. The median score among the raters was used to determine the final rating for each scenario. The final rating was compared between modifier levels. Spearman's rank correlation between each modifier and the final rating was determined. A multivariable ordinal regression model was fit to determine the adjusted odds of an "Appropriate" final rating while adjusting for radiographic diagnosis, number of levels and symptom type. Three decision trees were developed using decision tree classification models and variable importance for each tree was computed.

Results: Of the 263 scenarios, 47 (17.9 %) were rated as rarely appropriate, 66 (25%) as uncertain and 150 (57%) were rated as appropriate. Symptom type was the modifier most strongly correlated with the final rating (adjusted ρ2 = 0.58, p<.01). A multivariable ordinal regression adjusting for symptom type, diagnosis, and number of levels and showed high discriminative ability (C statistic = 0.90) and the adjusted odds ratio (aOR) of receiving a final rating of "Appropriate" was highest for myelopathy (aOR, 7.1) and radiculopathy (aOR, 4.8). Three decision tree models showed that symptom type and radiographic diagnosis had the highest variable importance.

Conclusions: Appropriate use criteria for cervical fusion in the setting of cervical degenerative disorders were developed. Symptom type was most strongly correlated with final rating. Myelopathy or radiculopathy were most strongly associated with an "Appropriate" rating, while axial pain without stenosis was most associated with "Rarely Appropriate."
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http://dx.doi.org/10.1016/j.spinee.2021.05.023DOI Listing
June 2021

Operative versus Nonoperative Management of Idiopathic Spinal Cord Herniation: Effect on Symptomatology and Disease Progression.

World Neurosurg 2021 May 24. Epub 2021 May 24.

Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA. Electronic address:

Background: Idiopathic spinal cord herniation (ISCH) is a rare pathology characterized by extravasation of the spinal cord through a dural defect. The optimal algorithm for choosing operative or nonoperative management is not well elucidated, partially because of the rarity of this pathology. We present the largest single-center series of ISCH and compare operative treatment to conservative management.

Methods: A retrospective case series of all patients evaluated for treatment of ISCH at our institution between 2010 and 2019 was conducted. Demographic variables, presenting symptoms, and imaging characteristics were assessed for all patients. For patients who underwent operative treatment, surgical approach, postoperative course, and discharge outcomes were recorded. Follow-up notes were reviewed for status of symptoms and functional capabilities, which were synthesized into Odom's criteria score.

Results: Sixteen patients met the inclusion criteria for this study, 8 of whom underwent operative treatment. No significant differences were found between operative and nonoperative groups with regard to demographic variables or pathology characteristics. Odom's criteria scores for the operative cohort were 12.5% (1 of 8) Excellent, 62.5% (5 of 8) Good, 12.5% (1 of 8) Fair, and 12.5% (1 of 8) Poor. Odom's criteria scores for the nonoperative cohort were 16.7% (1 of 6) Excellent, 33.3% (2 of 6) Good, 16.7% (1 of 6) Fair, and 33.3% (2 of 6) Poor. There was no significant difference between Odom's criteria score distribution between the operative and nonoperative groups at latest follow up (P = 0.715).

Conclusions: Conservative management of spinal cord herniation is an option that does not preclude symptomatic improvement in patients with idiopathic spinal cord herniation.
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http://dx.doi.org/10.1016/j.wneu.2021.05.046DOI Listing
May 2021

Longitudinal Impact of Acute Spinal Cord Injury on Clinical Pharmacokinetics of Riluzole, a Potential Neuroprotective Agent.

J Clin Pharmacol 2021 Apr 28. Epub 2021 Apr 28.

Department of Neurosurgery, Houston Methodist Research Institute, Houston, Texas, USA.

Riluzole, a benzothiazole sodium channel blocker that received US Food and Drug Administration approval to attenuate neurodegeneration in amyotrophic lateral sclerosis in 1995, was found to be safe and potentially efficacious in a spinal cord injury (SCI) population, as evident in a phase I clinical trial. The acute and progressive nature of traumatic SCI and the complexity of secondary injury processes can alter the pharmacokinetics of therapeutics. A 1-compartment with first-order elimination population pharmacokinetic model for riluzole incorporating time-dependent clearance and volume of distribution was developed from combined data of the phase 1 and the ongoing phase 2/3 trials. This change in therapeutic exposure may lead to a biased estimate of the exposure-response relationship when evaluating therapeutic effects. With the developed model, a rational, optimal dosing scheme can be designed with time-dependent modification that preserves the required therapeutic exposure of riluzole.
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http://dx.doi.org/10.1002/jcph.1876DOI Listing
April 2021

Long-segment posterior cervical decompression and fusion: does caudal level affect revision rate?

J Neurosurg Spine 2021 Apr 23:1-7. Epub 2021 Apr 23.

1Department of Neurosurgery, Thomas Jefferson University and Jefferson Hospital for Neuroscience, Philadelphia; and.

Objective: Posterior cervical decompression and fusion (PCDF) is a commonly performed procedure to address cervical myelopathy. A significant number of these patients require revision surgery for adjacent-segment disease (ASD) or pseudarthrosis. Currently, there is no consensus among spine surgeons on the inclusion of proximal thoracic spine instrumentation. This study investigates the benefits of thoracic extension in long-segment cervical fusions and the potential drawbacks. The authors compare outcomes in long-segment subaxial cervical fusion for degenerative cervical myelopathy with caudal vertebral levels of C6, C7, and T1.

Methods: A retrospective analysis identified 369 patients who underwent PCDF. Patients were grouped by caudal fusion level. Reoperation rates for ASD and pseudarthrosis, infection, and blood loss were examined. Data were analyzed with chi-square, 1-way ANOVA, and logistic regression.

Results: The total reoperation rate for symptomatic pseudarthrosis or ASD was 4.8%. Reoperation rates, although not significant, were lower in the C3-6 group (2.6%, vs 8.3% for C3-7 and 3.8% for C3-T1; p = 0.129). Similarly, rates of infection were lower in the shorter-segment fusion without achieving statistical significance (2.6% for C3-6, vs 5.6% for C3-7 and 5.5% for C3-T1; p = 0.573). The mean blood loss was documented as 104, 125, and 224 mL for groups 1, 2, and 3, respectively (p < 0.001).

Conclusions: Given the lack of statistical difference in reoperation rates for long-segment cervical fusions ending at C6, C7, or T1, shorter fusions in high-risk surgical candidates or elderly patients may be performed without higher rates of reoperation.
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http://dx.doi.org/10.3171/2020.10.SPINE201385DOI Listing
April 2021

Achieving Value in Spine Surgery: 10 Major Cost Contributors.

Global Spine J 2021 Apr;11(1_suppl):14S-22S

Department of Neurological Surgery, 6559Thomas Jefferson University, Philadelphia, PA, USA.

Study Design: Narrative Review.

Objectives: The increasing cost of healthcare overall and for spine surgery, coupled with the growing burden of spine-related disease and rising demand have necessitated a shift in practice standards with a new emphasis on value-based care. Despite multiple attempts to reconcile the discrepancy between national recommendations for appropriate use and the patterns of use employed in clinical practice, resources continue to be overused-often in the absence of any demonstrable clinical benefit. The following discussion illustrates 10 areas for further research and quality improvement.

Methods: We present a narrative review of the literature regarding 10 features in spine surgery which are characterized by substantial disproportionate costs and minimal-if any-clear benefit. Discussion items were generated from a service-wide poll; topics mentioned with great frequency or emphasis were considered. Items are not listed in hierarchical order, nor is the list comprehensive.

Results: We describe the cost and clinical data for the following 10 items: Over-referral, Over-imaging & Overdiagnosis; Advanced Imaging for Low Back Pain; Advanced imaging for C-Spine Clearance; Advanced Imaging for Other Spinal Trauma; Neuromonitoring for Cervical Spine; Neuromonitoring for Lumbar Spine/Single-Level Surgery; Bracing & Spinal Orthotics; Biologics; Robotic Assistance; Unnecessary perioperative testing.

Conclusions: In the pursuit of value in spine surgery we must define what quality is, and what costs we are willing to pay for each theoretical unit of quality. We illustrate 10 areas for future research and quality improvement initiatives, which are at present overpriced and underbeneficial.
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http://dx.doi.org/10.1177/2192568220971288DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076814PMC
April 2021

Bundled Payment Models in Spine Surgery.

Global Spine J 2021 Apr;11(1_suppl):7S-13S

Department of Neurosurgery, 6559Thomas Jefferson University and Jefferson Hospital for Neuroscience, Philadelphia, PA, USA.

Study Design: The following is a narrative discussion of bundled payments in spine surgery.

Objective: The cost of healthcare in the United States has continued to increase. To lower the cost of healthcare, reimbursement models are being investigated as potential cost saving interventions by driving incentives and quality improvement in fields such a spine surgery.

Methods: Narrative overview of literature pertaining to bundled payments in spine surgery synthesizing findings from computerized databases and authoritative texts.

Results: Spine surgery is challenging to define payment modes because of high cost variability and surgical decision-making nuances. While implementing bundled care payments in spine surgery, it is important to understand concepts such as value-based purchasing, episodes of care, prospective versus retrospective payment models, one versus two-sided risk, risk adjustment, and outlier protection. Strategies for implementation underscore the importance of risk stratification and modeling, adoption of evidence based clinical pathways, and data collection and dissemination. While bundled care models have been successfully implemented, challenges facing institutions adopting bundled care payment models include financial stressors during adoption of the model, distribution of risks, incentivization of treating only low risk patients, and nuanced variation in procedures leading to variation in costs.

Conclusion: An alternative for fee for service payments, bundled care payments may lead to higher cost savings and surgeon accountability in a patient's care.
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http://dx.doi.org/10.1177/2192568220974977DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076809PMC
April 2021

Trajectory-Based Classification of Recovery in Sensorimotor Complete Traumatic Cervical Spinal Cord Injury.

Neurology 2021 Apr 13. Epub 2021 Apr 13.

Division of Neurosurgery and Spine Program, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Objective: To test the hypothesis that sensorimotor complete traumatic cervical spinal cord injury is a heterogenous clinical entity comprising several subpopulations that follow fundamentally different trajectories of neurologic recovery.

Methods: We analyzed demographic and injury data from 655 patients who were pooled from 4 prospective longitudinal multicenter studies. Group based trajectory modeling was applied to model neurologic recovery trajectories over the initial 12-months postinjury and to identify predictors of recovery trajectories. Neurologic outcomes included: Upper Extremity Motor Score, Total Motor Scores and AIS grade improvement.

Results: The analysis identified 3 distinct trajectories of neurologic recovery. These clinical courses included: (1) Marginal recovery trajectory: characterized by minimal or no improvement in motor strength or change in AIS grade status (remained grade A); (2) Moderate recovery trajectory: characterized by low baseline motor scores that improved approximately 13 points; or AIS conversion of one grade point; (3) Good recovery trajectory: characterized by baseline motor scores in the upper quartile that improved to near maximum values within 3 months of injury. Patients following the moderate or good recovery trajectories were of younger age, had more caudally located injuries, a higher degree of preserved motor and sensory function at baseline examination and exhibited a greater extent of motor and sensory function in the zone of partial preservation.

Conclusion: Cervical complete SCI can be classified into one of 3 distinct subpopulations with fundamentally different trajectories of neurologic recovery. This study defines unique clinical phenotypes based on potential for recovery, rather than baseline severity of injury alone. This approach may prove beneficial in clinical prognostication and in the design and interpretation of clinical trials in SCI.
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http://dx.doi.org/10.1212/WNL.0000000000012028DOI Listing
April 2021

Commentary on "A Prospective, Single-Blinded, Bicentric Study, and Literature Review to Assess the Need of C2-Ganglion Preservation - SAVIOUR's Criteria".

Authors:
James S Harrop

Neurospine 2021 Mar 31;18(1):96-97. Epub 2021 Mar 31.

Department of Neurological and Orthopedic Surgery, Thomas Jefferson University, Philadelphia, PA, USA.

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http://dx.doi.org/10.14245/ns.2142238.119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021823PMC
March 2021

Overview of Traumatic Brain Injury in American Football Athletes.

Clin J Sport Med 2021 Mar 24. Epub 2021 Mar 24.

Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, Pennsylvania; Rothman Sports Concussion Institute, Rothman Institute, Philadelphia, Pennsylvania; and Department of Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania.

Objective: The aim of this review is to provide a summary of the epidemiology, clinical presentation, pathophysiology, and treatment of traumatic brain injury in collision athletes, particularly those participating in American football.

Data Sources: A literature search was conducted using the PubMed/MEDLINE and Google Scholar databases for publications between 1990 and 2019. The following search phrases were used: "concussion," "professional athletes," "collision athletes," "mild traumatic brain injury," "severe traumatic brain injury," "management of concussion," "management of severe traumatic brain injury," and "chronic traumatic encephalopathy." Publications that did not present epidemiology, clinical presentation, pathophysiology, radiological evaluation, or management were omitted. Classic articles as per senior author recommendations were retrieved through reference review.

Results: The results of the literature review yielded 147 references: 21 articles discussing epidemiology, 16 discussing clinical presentation, 34 discussing etiology and pathophysiology, 10 discussing radiological evaluation, 34 articles for on-field management, and 32 articles for medical and surgical management.

Conclusion: Traumatic brain injuries are frequent in professional collision athletes, and more severe injuries can have devastating and lasting consequences. Although sport-related concussions are well studied in professional American football, there is limited literature on the epidemiology and management of severe traumatic brain injuries. This article reviews the epidemiology, as well as the current practices in sideline evaluation, acute management, and surgical treatment of concussions and severe traumatic brain injury in professional collision athletes. Return-to-play decisions should be based on individual patient symptoms and recovery.
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http://dx.doi.org/10.1097/JSM.0000000000000918DOI Listing
March 2021

Intradural extramedullary capillary hemangioma of the cauda equina: case report of a rare spinal tumor.

Spinal Cord Ser Cases 2021 Mar 19;7(1):21. Epub 2021 Mar 19.

Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.

Introduction: Intradural extramedullary capillary hemangiomas of the cauda equina are exceedingly rare, with only 20 previous cases reported. In the adult population, these tumors are rare and can arise in the central and peripheral nervous systems from the dura or spinal nerve roots. Intradural capillary hemangiomas of the cauda equina can yield symptoms such as lower extremity weakness, pain, and bladder and bowel dysfunction. The clinical symptomology and surgical management of this rare spinal lesion are reviewed in this case report.

Case Presentation: A 50-year-old male presented with progressive bilateral lower extremity weakness for 2 years, with recent bladder and bowel dysfunction. On physical exam, strength was symmetrically impaired in both lower extremities. Pre-operative magnetic resonance imaging (MRI) of the lumbar spine demonstrated a gadolinium-enhanced intradural lesion at the L4 level. Laminectomy was performed and the lesion was resected. Histopathological analysis determined that the tumor demonstrated features consistent with a capillary hemangioma.

Discussion: Clinically, patients with capillary hemangiomas of the cauda equina present with space-occupying compressive deficits, including progressive low back and lower extremity pain, motor deficits, paresthesias, sensory loss, and bowel and bladder dysfunction. Acute presentation can transpire following a hemorrhagic episode, although this is more associated with cavernous rather than capillary hemangiomas. Our patient demonstrated non-acute, progressive weakness, and late-onset bladder and bowel dysfunction. This report demonstrates that this rare lesion should be included in the differential diagnosis of cauda equina lesions.
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http://dx.doi.org/10.1038/s41394-021-00383-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7979701PMC
March 2021

Are Guidelines Important? Results of a Prospective Quality Improvement Lumbar Fusion Project.

Neurosurgery 2021 Jun;89(1):77-84

Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.

Background: United States (U.S.) healthcare is a volume-based inefficient delivery system. Value requires the consideration of quality, which is lacking in most healthcare disciplines.

Objective: To assess whether patients who met specific evidence-based medicine (EBM)-based criteria preoperatively for lumbar fusion would achieve higher rates of achieving the minimal clinical important difference (MCID) than those who did not meet the EBM indications.

Methods: All elective lumbar fusion cases, March 2018 to August 2019, were prospectively evaluated and categorized based on EBM guidelines for surgical indications. The MCID was defined as a reduction of ≥5 points in Oswestry Disability Index (ODI). Multiple logistic regression identified multivariable-adjusted odds ratio of EBM concordance.

Results: A total of 325 lumbar fusion patients were entered with 6-mo follow-up data available for 309 patients (95%). The median preoperative ODI score was 24.4 with median 6-mo improvement of 7.0 points (P < .0001). Based on ODI scores, 79.6% (246/309) improved, 3.8% (12/309) had no change, and 16% (51/309) worsened. A total of 191 patients had ODI improvement reaching the MCID. 93.2% (288/309) cases were EBM concordant, while 6.7% (21/309) were not.In multivariate analysis, EBM concordance (P = .0338), lower preoperative ODI (P < .001), lower ASA (American Society of Anesthesiologists) (P = .0056), and primary surgeries (P = .0004) were significantly associated with improved functional outcome. EBM concordance conferred a 3.04 (95% CI 1.10-8.40) times greater odds of achieving MCID in ODI at 6 mo (P = .0322), adjusting for other factors.

Conclusion: This analysis provides validation of EBM guideline criteria to establish optimal patient outcomes. The EBM concordant patients had a greater than 3 times improved outcome compared to those not meeting EBM fusion criteria.
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http://dx.doi.org/10.1093/neuros/nyab062DOI Listing
June 2021

Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.

JAMA 2021 03;325(10):942-951

Neurosurgery, Cleveland Clinic Foundation, Cleveland, Ohio.

Importance: Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results.

Objective: To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year.

Design, Setting, And Participants: Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020.

Interventions: Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion.

Main Outcomes And Measures: The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score.

Results: Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%).

Conclusions And Relevance: Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach.

Trial Registration: ClinicalTrials.gov Identifier: NCT02076113.
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http://dx.doi.org/10.1001/jama.2021.1233DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7944378PMC
March 2021

Utility of prediction model score: a proposed tool to standardize the performance and generalizability of clinical predictive models based on systematic review.

J Neurosurg Spine 2021 Feb 26:1-9. Epub 2021 Feb 26.

1Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Objective: The objective of this study was to evaluate the characteristics and performance of current prediction models in the fields of spine metastasis and degenerative spine disease to create a scoring system that allows direct comparison of the prediction models.

Methods: A systematic search of PubMed and Embase was performed to identify relevant studies that included either the proposal of a prediction model or an external validation of a previously proposed prediction model with 1-year outcomes. Characteristics of the original study and discriminative performance of external validations were then assigned points based on thresholds from the overall cohort.

Results: Nine prediction models were included in the spine metastasis category, while 6 prediction models were included in the degenerative spine category. After assigning the proposed utility of prediction model score to the spine metastasis prediction models, only 1 reached the grade of excellent, while 2 were graded as good, 3 as fair, and 3 as poor. Of the 6 included degenerative spine models, 1 reached the excellent grade, while 3 studies were graded as good, 1 as fair, and 1 as poor.

Conclusions: As interest in utilizing predictive analytics in spine surgery increases, there is a concomitant increase in the number of published prediction models that differ in methodology and performance. Prior to applying these models to patient care, these models must be evaluated. To begin addressing this issue, the authors proposed a grading system that compares these models based on various metrics related to their original design as well as internal and external validation. Ultimately, this may hopefully aid clinicians in determining the relative validity and usability of a given model.
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http://dx.doi.org/10.3171/2020.8.SPINE20963DOI Listing
February 2021

Association Between Postoperative Fever and Readmission Rates in Lumbar Fusion Patients.

Clin Spine Surg 2021 Jul;34(6):E349-E353

Department of Neurosurgery, Thomas Jefferson University and Jefferson Hospital for Neuroscience.

Study Design: This is a retrospective observational study.

Objective: This study evaluates the impact of postoperative fever on the rate of readmission among lumbar fusion patients.

Summary Of Background Data: Postoperative fever is a common event across surgical specialties that often triggers an extensive work-up that can significantly increase hospital costs and length of stay, although the results are usually negative for infection. There is a paucity of literature studying postoperative fever in lumbar fusion patients.

Materials And Methods: A retrospective chart review of all the patients who underwent elective posterior lumbar spinal fusion from January, 2018 to November, 2018 was conducted. Fever was defined as a temperature >100.4ºF. Patients were categorized into 4 groups based on their highest recorded temperature postoperatively. The association between demographic variables, tests ordered per patient, length of stay, and readmission rates per group were analyzed using a t test, and 1-way analysis of variance for continuous outcomes, and the Fisher exact test for categorical variables.

Results: Of 107 patients, 58% had no fever recorded, 17.75% had temperatures between 100.5 and 100.90ºF, 18.69% temperatures between 101 and 101.90ºF, and 4.67% of patients temperatures equal or higher than 102.0ºF. The number of tests per patient increase with the range of temperatures analyzed (P<0.01), but the rate of readmission of all the 4 groups are not significantly different (0.107). There is no significant difference in the number of febrile episodes per day between patients who were and who were not readmitted (0.209).

Conclusions: A diagnostic testing policy guided by clinician assessment of symptoms and physical exam may limit unnecessary testing and reduce hospital length of stay and cost without sacrificing patient safety.
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http://dx.doi.org/10.1097/BSD.0000000000001131DOI Listing
July 2021

A Randomized Controlled Trial of Local Delivery of a Rho Inhibitor (VX-210) in Patients with Acute Traumatic Cervical Spinal Cord Injury.

J Neurotrauma 2021 Mar 1. Epub 2021 Mar 1.

BioAxone BioSciences, Inc, Boston, Massachusetts, USA.

Acute traumatic spinal cord injury (SCI) can result in severe, lifelong neurological deficits. After SCI, Rho activation contributes to collapse of axonal growth cones, failure of axonal regeneration, and neuronal loss. This randomized, double-blind, placebo-controlled phase 2b/3 study evaluated the efficacy and safety of Rho inhibitor VX-210 (9 mg) in patients after acute traumatic cervical SCI. The study enrolled patients 14-75 years of age with acute traumatic cervical SCIs, C4-C7 (motor level) on each side, and American Spinal Injury Association Impairment Scale (AIS) Grade A or B who had spinal decompression/stabilization surgery commencing within 72 h after injury. Patients were randomized 1:1 with stratification by age (<30 vs. ≥30 years) and AIS grade (A vs. B with sacral pinprick preservation vs. B without sacral pinprick preservation). A single dose of VX-210 or placebo in fibrin sealant was administered topically onto the dura over the site of injury during decompression/stabilization surgery. Patients were evaluated for medical, neurological, and functional changes, and serum was collected for pharmacokinetics and immunological analyses. Patients were followed up for up to 12 months after treatment. A planned interim efficacy-based futility analysis was conducted after ∼33% of patients were enrolled. The pre-defined futility stopping rule was met, and the study was therefore ended prematurely. In the final analysis, the primary efficacy end-point was not met, with no statistically significant difference in change from baseline in upper-extremity motor score at 6 months after treatment between the VX-210 (9-mg) and placebo groups. This work opens the door to further improvements in the design and conduct of clinical trials in acute SCI.
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http://dx.doi.org/10.1089/neu.2020.7096DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8309435PMC
March 2021

A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study.

J Neurosurg Spine 2021 Feb 5:1-10. Epub 2021 Feb 5.

7InVivo Therapeutics Corp., Cambridge, Massachusetts.

Objective: The aim of this study was to evaluate whether the investigational Neuro-Spinal Scaffold (NSS), a highly porous bioresorbable polymer device, demonstrates probable benefit for safety and neurological recovery in patients with complete (AIS grade A) T2-12 spinal cord injury (SCI) when implanted ≤ 96 hours postinjury.

Methods: This was a prospective, open-label, multicenter, single-arm study in patients with a visible contusion on MRI. The NSS was implanted into the epicenter of the postirrigation intramedullary spinal cord contusion cavity with the intention of providing structural support to the injured spinal cord parenchyma. The primary efficacy endpoint was the proportion of patients who had an improvement of ≥ 1 AIS grade (i.e., conversion from complete paraplegia to incomplete paraplegia) at the 6-month follow-up visit. A preset objective performance criterion established for the study was defined as an AIS grade conversion rate of ≥ 25%. Secondary endpoints included change in neurological level of injury (NLI). This analysis reports on data through 6-month follow-up assessments.

Results: Nineteen patients underwent NSS implantation. There were 3 early withdrawals due to death, which were all determined by investigators to be unrelated to the NSS or the implantation procedure. Seven of 16 patients (43.8%) who completed the 6-month follow-up visit had conversion of neurological status (AIS grade A to grade B [n = 5] or C [n = 2]). Five patients showed improvement in NLI of 1 to 2 levels compared with preimplantation assessment, 3 patients showed no change, and 8 patients showed deterioration of 1 to 4 levels. There were no unanticipated or serious adverse device effects or serious adverse events related to the NSS or the implantation procedure as determined by investigators.

Conclusions: In this first-in-human study, implantation of the NSS within the spinal cord appeared to be safe in the setting of surgical decompression and stabilization for complete (AIS grade A) thoracic SCI. It was associated with a 6-month AIS grade conversion rate that exceeded historical controls. The INSPIRE study data demonstrate that the potential benefits of the NSS outweigh the risks in this patient population and support further clinical investigation in a randomized controlled trial.Clinical trial registration no.: NCT02138110 (clinicaltrials.gov).
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http://dx.doi.org/10.3171/2020.8.SPINE191507DOI Listing
February 2021

Spinal ganglion cyst presenting with radiculopathy: diagnostic challenges and differential.

Spinal Cord Ser Cases 2021 Jan 19;7(1). Epub 2021 Jan 19.

Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA, USA.

Introduction: Ganglion cysts are benign soft tissue lesions, usually arising from periarticular connective tissue. These are very rarely reported in the spine, but when seen can cause radiculopathy or myelopathy.

Case Presentation: A 68-year-old female patient presented with worsening radiculopathy and right foot drop and imaging noted a right L5-S1 foraminal mass. The lesion was gross totally resected. Histological analysis revealed myxoid degeneration and inflammation, without a synovial lining, consistent with ganglion cyst.

Discussion: While uncommon, intra-foraminal ganglion cysts can be distinguished from synovial cysts through imaging and histology and are typically amenable to surgical resection. Greater knowledge and insight about differentiating ganglion versus synovial cyst may prevent resection of facet joints and prevent a fusion procedure.
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http://dx.doi.org/10.1038/s41394-020-00373-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815751PMC
January 2021

The Impact of Intraoperative Image-Guidance Modalities and Neurophysiologic Monitoring in the Safety of Sacroiliac Fusions.

Global Spine J 2021 Jan 12:2192568220981977. Epub 2021 Jan 12.

Department of Neurosurgery, 6559Thomas Jefferson University and Jefferson Hospital for Neuroscience, Philadelphia, PA, USA.

Study Design: Retrospective observational cohort.

Objective: A review of efficiency and safety of fluoroscopy and stereotactic navigation system for minimally invasive (MIS) Sacroiliac (SI) fusion through a lateral technique.

Methods: Retrospective analysis of an observational cohort of 96 patients greater than 18 years old, that underwent MIS SI fusion guided by fluoroscopy or navigation between January 2013 and April 2020 with a minimum of 3 months follow-up. Intraoperative neuromonitoring (IONM) with a variable combination of electromyography (EMG), somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs) was also utilized.

Results: The overall complication rate in the study was 9.4%, and there was no difference between the fluoroscopy (10.1%), and navigation groups (8%). Neurological complication rate was 2.1%, without a significant difference between both intraoperative guidance modality groups (p = 0.227). There was a significant difference between the modalities of IONM used and the occurrence of neurological injury (p = 0.01).The 2 patients who had a neurological complication postoperatively were monitored only with EMG and SSEP, but none of the patients (n = 76) in which MEPs were utilized had neurologic complication. The mean pain improvement 3 months after surgery was greater in the navigation group (2.44 ± 2.72), but was not statistically different than the improvement in the fluoroscopy group (1.90 ± 2.07) (p = 0.301).

Conclusions: No difference in the safety of the procedure was found between the fluoroscopy and the stereotactic navigation techniques. The contribution of the IONM to the safety of SI fusions could not be determined, but the data indicates that MEPs provide the highest level of sensitivity.
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http://dx.doi.org/10.1177/2192568220981977DOI Listing
January 2021

The influence of timing of surgical decompression for acute spinal cord injury: a pooled analysis of individual patient data.

Lancet Neurol 2021 02 21;20(2):117-126. Epub 2020 Dec 21.

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, ON, Canada. Electronic address:

Background: Although there is a strong biological rationale for early decompression of the injured spinal cord, the influence of the timing of surgical decompression for acute spinal cord injury (SCI) remains debated, with substantial variability in clinical practice. We aimed to objectively evaluate the effect of timing of decompressive surgery for acute SCI on long-term neurological outcomes.

Methods: We did a pooled analysis of individual patient data derived from four independent, prospective, multicentre data sources, including data from December, 1991, to March, 2017. Three of these studies had been published; of these, only one study previously specifically analysed the effect of the timing of surgical decompression. These four datasets were selected because they were among the highest quality acute SCI datasets available and contained highly granular data. Individual patient data were obtained by request from study authors. All patients who underwent decompressive surgery for acute SCI within these datasets were included. Patients were stratified into early (<24 h after spinal injury) and late (≥24 h after spinal injury) decompression groups. Neurological outcomes were assessed by American Spinal Injury Association (ASIA), or International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), examination. The primary endpoint was change in total motor score from baseline to 1 year after spinal injury. Secondary endpoints were ASIA Impairment Scale (AIS) grade and change in upper-extremity motor, lower-extremity motor, light touch, and pin prick scores after 1 year. One-stage meta-analyses were done by hierarchical mixed-effects regression adjusting for baseline score, age, mechanism of injury, AIS grade, level of injury, and administration of methylprednisolone. Effect sizes were summarised by mean difference (MD) for sensorimotor scores and common odds ratio (cOR) for AIS grade, with corresponding 95% CIs. As a secondary analysis, change in total motor score was regressed against time to surgical decompression (h) as a continuous variable, using a restricted cubic spline with adjustment for the same covariates as in the primary analysis.

Findings: We identified 1548 eligible patients from the four datasets. Outcome data at 1 year after spinal injury were available for 1031 patients (66·6%). Patients who underwent early surgical decompression (n=528) experienced greater recovery than patients who had late decompression surgery (n=1020) at 1 year after spinal injury; total motor scores improved by 23·7 points (95% CI 19·2-28·2) in the early surgery group versus 19·7 points (15·3-24·0) in the late surgery group (MD 4·0 points [1·7-6·3]; p=0·0006), light touch scores improved by 19·0 points (15·1-23·0) vs 14·8 points (11·2-18·4; MD 4·3 [1·6-7·0]; p=0·0021), and pin prick scores improved by 18·3 points (13·7-22·9) versus 14·2 points (9·8-18·6; MD 4·0 [1·5-6·6]; p=0·0020). Patients who had early decompression also had better AIS grades at 1 year after surgery, indicating less severe impairment, compared with patients who had late surgery (cOR 1·48 [95% CI 1·16-1·89]; p=0·0019). When time to surgical decompression was modelled as a continuous variable, there was a steep decline in change in total motor score with increasing time during the first 24-36 h after injury (p<0·0001); and after 36 h, change in total motor score plateaued.

Interpretation: Surgical decompression within 24 h of acute SCI is associated with improved sensorimotor recovery. The first 24-36 h after injury appears to represent a crucial time window to achieve optimal neurological recovery with decompressive surgery following acute SCI.

Funding: None.
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http://dx.doi.org/10.1016/S1474-4422(20)30406-3DOI Listing
February 2021

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.

Lancet Neurol 2021 02 22;20(2):98-106. Epub 2020 Dec 22.

Department of Health Services, University of Washington, Seattle, WA, USA.

Background: 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.
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http://dx.doi.org/10.1016/S1474-4422(20)30407-5DOI Listing
February 2021

Combined Anterior Osteophytectomy and Cricopharyngeal Myotomy for Treatment of DISH-Associated Dysphagia.

Global Spine J 2020 Nov 18:2192568220967358. Epub 2020 Nov 18.

Thomas Jefferson University, Philadelphia, PA, USA.

Study Design: Retrospective observational case series.

Objective: To assess the outcome of patients with diffuse idiopathic skeletal hyperostosis (DISH) with dysphagia who underwent cricopharyngeal myotomy (CPM) in conjunction with anterior osteophytectomy (OP).

Methods: This is a retrospective observational study of 9 patients that received combined intervention by neurosurgeons and otolaryngologists. Inclusion criteria for surgery consisted of patients who failed to respond to conservative treatments for dysphagia and had evidence of both upper esophageal dysfunction and osteophyte compression. We present the largest series in literature to date including patients undergoing combined OP and CPM.

Results: A total of 88.9% (8/9) of the patients who underwent OP and CPM showed improvement in their symptoms. Of the aforementioned group, 22.2% of these patients had complete resolution of their symptoms, 11.1% did not improve, and only 2 patients showed recurrence of their symptoms. None of the patients in whom surgery was performed required reoperation or suffered serious complication related to the surgical procedures.

Conclusion: Based on the literature results, high rate of improvements in dysphagia, and low rate of complications, combined OP and CPM procedures may be beneficial to a carefully selected group of patients.
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http://dx.doi.org/10.1177/2192568220967358DOI Listing
November 2020

Reference accuracy in spine surgery.

J Neurosurg Spine 2020 Sep 25:1-5. Epub 2020 Sep 25.

1Department of Neurosurgery, Thomas Jefferson University and Jefferson Hospital for Neuroscience, Philadelphia, Pennsylvania.

Objective: The references list is an important part of a scientific article that serves to confirm the accuracy of the authors' statements. The goal of this study was to evaluate the reference accuracy in the field of spine surgery.

Methods: Four major peer-reviewed spine surgery journals were chosen for this study based on their subspecialty clinical impact factors. Sixty articles per journal were selected from 12 issues each of The Spine Journal, Spine, and Journal of Neurosurgery: Spine, and 40 articles were selected from 8 issues of Global Spine Journal, for a total of 220 articles. All the articles were published in 2019 and were selected using computer-generated numbers. From the references list of each article, one reference was again selected by using a computer-generated number and then checked for citation or quotation errors.

Results: The results indicate that 84.1% of articles have a minor citation error, 4.5% of articles have a major citation error, 9.5% of articles have a minor quotation error, and 9.1% of articles have a major quotation error. Journal of Neurosurgery: Spine had the fewest citation errors compared with the other journals evaluated in this study. Using chi-square analysis, no association was determined between the occurrence of errors and potential markers of reference mistakes. Still, statistical significance was found between the occurrence of citation errors and the spine journals tested.

Conclusions: In order to advance medical treatment and patient care in spine surgery, detailed documentation and attention to detail are necessary. The results from this study illustrate that improved reference accuracy is required.
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http://dx.doi.org/10.3171/2020.6.SPINE20640DOI Listing
September 2020

Development of a Telemedicine Neurological Examination for Spine Surgery: A Pilot Trial.

Clin Spine Surg 2020 11;33(9):355-369

Department of Orthopaedic Surgery, Rothman Orthopaedic Institute at Thomas Jefferson University Hospital.

Study Design: This was a prospective cohort study.

Objective: The objective of this study was to design and test a novel spine neurological examination adapted for telemedicine.

Summary Of Background Data: Telemedicine is a rapidly evolving technology associated with numerous potential benefits for health care, especially in the modern era of value-based care. To date, no studies have assessed whether.

Methods: Twenty-one healthy controls and 20 patients with cervical or lumbar spinal disease (D) were prospectively enrolled. Each patient underwent a telemedicine neurological examination as well as a traditional in-person neurological examination administered by a fellowship trained spine surgeon and a physiatrist. Both the telemedicine and in-person tests consisted of motor, sensory, and special test components. Scores were compared via univariate analysis and secondary qualitative outcomes, including responses from a satisfaction survey, were obtained upon completion of the trial.

Results: Of the 20 patients in the D group, 9 patients had cervical disease and 11 patients had lumbar disease. Comparing healthy control with the D group, there were no significant differences with respect to all motor scores, most sensory scores, and all special tests. There was a high rate of satisfaction among the cohort with 92.7% of participants feeling "very satisfied" with the overall experience.

Conclusions: This study presents the development of a viable neurological spine examination adapted for telemedicine. The findings in this study suggest that patients have comparable motor, sensory, and special test scores with telemedicine as with a traditional in-person examination administered by an experienced clinician, as well as reporting a high rate of satisfaction among participants. To our knowledge, this is the first telemedicine neurological examination for spine surgery. Further studies are warranted to validate these findings.
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http://dx.doi.org/10.1097/BSD.0000000000001066DOI Listing
November 2020

How accurate is the neurosurgery literature? A review of references.

Acta Neurochir (Wien) 2021 01 22;163(1):13-18. Epub 2020 Sep 22.

Division of Spine and Peripheral Nerve Surgery, Department of Neurosurgery, Thomas Jefferson University and Jefferson Hospital for Neuroscience, 901 Walnut Street 3rd Floor, Philadelphia, PA, 19107, USA.

Background: The reference list is an important part of academic manuscripts. The goal of this study is to evaluate the reference accuracy in the field of neurosurgery.

Methods: This study examines four major peer-reviewed neurosurgery journals, chosen based on their clinical impact factor: Neurosurgery, J Neurosurg, World Neurosurg, and Acta Neurochir. For each of the four journals, five articles from each of the journal's 12 issues published in 2019 were randomly selected using an online generator. This resulted in a total of 240 articles, 60 from each journal. Additionally, from each article's list of references, one reference was again randomly selected and checked for a citation or quotation error. The chi-square test was used to analyze the association between the occurrence of citation and quotation errors and the presence of hypothesized risk factors that could impact reference accuracy.

Results: 62.1% of articles had a minor citation error, 8.33% had a major citation error, 12.1% had a minor quotation error, and 5.8% of articles had a major quotation error. Overall, Acta Neurochir presented with the fewest quotation errors compared with the other journals evaluated. The only association between the frequency of errors and potential markers of reference mistakes was with the length of the bibliography. Surprisingly, this correlation indicated that the articles with longer reference lists had fewer citation errors (p < 0.01). Statistical significance was found between the occurrence of citation errors and the journals of publication (p < 0.01).

Conclusions: In order to advance medical treatment and patient care in neurosurgery, detailed documentation and attention to detail are necessary. The results from this analysis illustrate that improved reference accuracy is required.
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http://dx.doi.org/10.1007/s00701-020-04576-3DOI Listing
January 2021

Factors Affecting the Decision to Initiate Anticoagulation After Spine Surgery: Findings From the AOSpine Anticoagulation Global Initiative.

Global Spine J 2020 Sep 10:2192568220948027. Epub 2020 Sep 10.

2468Rush University Medical Center, Chicago, IL, USA.

Study Design: Cross-sectional, international survey.

Objectives: To identify factors influencing pharmacologic anticoagulation initiation after spine surgery based on the AOSpine Anticoagulation Global Survey.

Methods: This survey was distributed to the international membership of AOSpine (n = 3805). A Likert-type scale described grade practice-specific factors on a scale from low (1) to high (5) importance, and patient-specific factors a scale from low (0) to high (3) importance. Analysis was performed to determine which factors were significant in the decision making surrounding the initiation of pharmacologic anticoagulation.

Results: A total of 316 spine surgeons from 64 countries completed the survey. In terms of practice-specific factors considered to initiate treatment, expert opinion was graded the highest (mean grade ± SD = 3.2 ± 1.3), followed by fellowship training (3.2 ± 1.3). Conversely, previous studies (2.7 ± 1.2) and unspecified guidelines were considered least important (2.6 ± 1.6). Patient body mass index (2.0 ± 1.0) and postoperative mobilization (2.3 ± 1.0) were deemed most important and graded highly overall. Those who rated estimated blood loss with greater importance in anticoagulation initiation decision making were more likely to administer thromboprophylaxis at later times (hazard ratio [HR] = 0.68-0.71), while those who rated drain output with greater importance were likely to administer thromboprophylaxis at earlier times (HR = 1.32-1.43).

Conclusion: Among our global cohort of spine surgeons, certain patient factors (ie, patient mobilization and body mass index) and practice-specific factors (ie, expert opinion and fellowship training) were considered to be most important when considering anticoagulation start times.
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http://dx.doi.org/10.1177/2192568220948027DOI Listing
September 2020
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