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Marcel F. Dvorak, Michael G. Johnson, Michael Boyd, Garth Johnson, Brian K. Kwon, and Charles G. Fisher

Object. The primary goal of this study was to describe the long-term health-related quality of life (HRQOL) outcomes in patients who have suffered Jefferson-type fractures. These outcomes were compared with matched normative HRQOL data and with the patient's perceptions of their HRQOL prior to the injury. Variables that potentially influence these HRQOL outcomes were analyzed.

No standardized outcome assessments have been published for patients who suffer these fractures; their outcomes have long thought to be excellent following treatment. Determining the optimal surrogate measure to represent preinjury HRQOL in trauma patients is difficult.

Methods. A retrospective review, radiographic analysis, and cross-sectional outcome assessment were performed. The Short Form (SF)—36 and the American Academy of Orthopaedic Surgeons/North American Spine Society (AAOS/NASS) outcome instruments were filled out by patients at final follow-up examination (follow-up period 75 months, range 19–198 months) to represent their current status as well as their perceptions of preinjury status.

In 34 patients, the SF-36 physical component score and the AAOS/NASS pain values were significantly lower than normative values. There was no significant difference between normative and preinjury values. Spence criteria greater than 7 mm and the presence of associated injuries predicted poorer outcome scores during the follow-up period.

Conclusions. Long-term follow-up examination of patients with Jefferson fractures indicated that patients' status does not return to the level of their perceived preinjury health status or that of normative population controls. Those with other injuries and significant osseous displacement (≥ 7 mm total) may experience poorer long-term outcomes. Limitations of the study included a relatively low (60%) response rate and the difficulties of identifying an appropriate baseline outcome in a trauma population with which the follow-up outcomes can be compared.

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Diana S. L. Chow, Yang Teng, Elizabeth G. Toups, Bizhan Aarabi, James S. Harrop, Christopher I. Shaffrey, Michele M. Johnson, Maxwell Boakye, Ralph F. Frankowski, Michael G. Fehlings, and Robert G. Grossman

Object

The aim of this paper was to characterize individual and population pharmacokinetics of enterally administered riluzole in a Phase 1 clinical trial of riluzole as a neuroprotective agent in adults 18–70 years old with acute spinal cord injury (SCI).

Methods

Thirty-five individuals with acute SCI, American Spinal Injury Association Impairment Scale Grades A–C, neurological levels from C-4 to T-12, who were enrolled in the Phase 1 clinical trial sponsored by the North American Clinical Trials Network for Treatment of Spinal Cord Injury, received 50 mg riluzole twice daily for 28 doses. The first dose was administered at a mean of 8.7 ± 2.2 hours postinjury. Trough plasma samples were collected within 1 hour predose, and peak plasma samples were collected 2 hours postdose on Days 3 and 14 of treatment. Riluzole concentrations were quantified by high-performance liquid chromatography assay. The data were analyzed for individual and population pharmacokinetics using basic structural and covariate models. The pharmacokinetic measures studied were the peak concentration (Cmax), trough concentration (Cmin), systemic exposure (AUC0–12), clearance (CL/F), and volume of distribution (V_F) normalized by the bioavailability (F).

Results

The Cmax and AUC0–12 achieved in SCI patients were lower than those in ALS patients on the same dose basis, due to a higher CL and larger V. The pharmacokinetics of riluzole (Cmax, Cmin, AUC0–12, CL, and V) changed during the acute and subacute phases of SCI during the 14 days of therapy. It was consistently observed in patients at all clinical sites that Cmax, Cmin, and AUC0–12 (128.9 ng/ml, 45.6 ng/ml, and 982.0 ng × hr/ml, respectively) were significantly higher on Day 3 than on Day 14 (76.5 ng/ml, 19.1 ng/ml, and 521.0 ng × hr/ml, respectively). These changes resulted from lower CL (49.5 vs 106.2 L/hour) and smaller V (557.1 vs 1297.9/L) on Day 3. No fluid imbalance or cytochrome P 1A2 induction due to concomitant medications was identified during the treatment course to account for such increases in V and CL, respectively. Possible mechanisms underlying these changes are discussed.

Conclusions

This is the first report of clinical pharmacokinetics of riluzole in patients with SCI. The Cmax and AUC0–12 achieved in SCI patients were lower than those in ALS patients on the same dose basis, due to a higher clearance and larger volume of distribution in SCI patients. The finding in SCI patients of an increase in the clearance and distribution of riluzole between the 3rd and 14th days after SCI, with a lower plasma concentration of riluzole on the 14th day, stresses the importance of monitoring changes in drug metabolism after SCI in interpreting the safety and efficacy of therapeutic drugs that are used in clinical trials in SCI. Clinical trial registration no.: NCT00876889.

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Robert G. Grossman, Ralph F. Frankowski, Keith D. Burau, Elizabeth G. Toups, John W. Crommett, Michele M. Johnson, Michael G. Fehlings, Charles H. Tator, Christopher I. Shaffrey, Susan J. Harkema, Jonathan E. Hodes, Bizhan Aarabi, Michael K. Rosner, James D. Guest, and James S. Harrop

Object

The aim of this multicenter, prospective study was to determine the spectrum, incidence, and severity of complications during the initial hospitalization of patients with spinal cord injury.

Methods

The study was conducted at 9 university-affiliated hospitals that comprise the clinical centers of the North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury. The study population comprised 315 patients admitted to NACTN clinical centers between June 25, 2005, and November 2, 2010, who had American Spinal Injury Association (ASIA) Impairment Scale grades of A–D and were 18 years of age or older. Patients were managed according to a standardized protocol.

Results

The study population was 79% male with a median age of 44 years. The leading causes of injury were falls (37%) and motor vehicle accidents (28%). The distribution of initial ASIA grades were A (40%), B (16%), C (15%), and D (29%). Fifty-eight percent of patients sustained 1 or more severe, moderate, or mild complications. Complications were associated with more severe ASIA grade: 84% of patients with Grade A and 25% of patients with Grade D had at least 1 complication. Seventy-eight percent of complications occurred within 14 days of injury. The most frequent types of severe and moderate complications were respiratory failure, pneumonia, pleural effusion, anemia, cardiac dysrhythmia, and severe bradycardia. The mortality rate was 3.5% and was associated with increased age and preexisting morbidity.

Conclusions

Knowledge of the type, frequency, time of occurrence, and severity of specific complications that occur after spinal cord injury can aid in their early detection, treatment, and prevention. The data are of importance in evaluating and selecting therapy for clinical trials.

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Michael G. Fehlings, Jefferson R. Wilson, Ralph F. Frankowski, Elizabeth G. Toups, Bizhan Aarabi, James S. Harrop, Christopher I. Shaffrey, Susan J. Harkema, James D. Guest, Charles H. Tator, Keith D. Burau, Michele W. Johnson, and Robert G. Grossman

In the immediate period after traumatic spinal cord injury (SCI) a variety of secondary injury mechanisms combine to gradually expand the initial lesion size, potentially leading to diminished neurological outcomes at long-term follow-up. Riluzole, a benzothiazole drug, which has neuroprotective properties based on sodium channel blockade and mitigation of glutamatergic toxicity, is currently an approved drug that attenuates the extent of neuronal degeneration in patients with amyotrophic lateral sclerosis. Moreover, several preclinical SCI studies have associated riluzole administration with improved functional outcomes and increased neural tissue preservation. Based on these findings, riluzole has attracted considerable interest as a potential neuroprotective drug for the treatment of SCI. Currently, a Phase I trial evaluating the safety and pharmacokinetic profile of riluzole in human SCI patients is being conducted by the North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury. The current review summarizes the existing preclinical and clinical literature on riluzole, provides a detailed description of the Phase I trial, and suggests potential opportunities for future investigation. Clinical trial registration no.: NCT00876889.

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John S. Riley, Ryan M. Antiel, Alan W. Flake, Mark P. Johnson, Natalie E. Rintoul, John D. Lantos, Michael D. Traynor Jr., N. Scott Adzick, Chris Feudtner, and Gregory G. Heuer

OBJECTIVE

The Management of Myelomeningocele Study (MOMS) compared prenatal with postnatal surgery for myelomeningocele (MMC). The present study sought to determine how MOMS influenced the clinical recommendations of pediatric neurosurgeons, how surgeons’ risk tolerance affected their views, how their views compare to those of their colleagues in other specialties, and how their management of hydrocephalus compares to the guidelines used in the MOMS trial.

METHODS

A cross-sectional survey was sent to all 154 pediatric neurosurgeons in the American Society of Pediatric Neurosurgeons. The effect of surgeons’ risk tolerance on opinions and counseling of prenatal closure was determined by using ordered logistic regression.

RESULTS

Compared to postnatal closure, 71% of responding pediatric neurosurgeons viewed prenatal closure as either “very favorable” or “somewhat favorable,” and 51% reported being more likely to recommend prenatal surgery in light of MOMS. Compared to pediatric surgeons, neonatologists, and maternal-fetal medicine specialists, pediatric neurosurgeons viewed prenatal MMC repair less favorably (p < 0.001). Responders who believed the surgical risks were high were less likely to view prenatal surgery favorably and were also less likely to recommend prenatal surgery (p < 0.001). The management of hydrocephalus was variable, with 60% of responders using endoscopic third ventriculostomy in addition to ventriculoperitoneal shunts.

CONCLUSIONS

The majority of pediatric neurosurgeons have a favorable view of prenatal surgery for MMC following MOMS, although less so than in other specialties. The reported acceptability of surgical risks was strongly predictive of prenatal counseling. Variation in the management of hydrocephalus may impact outcomes following prenatal closure.

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Michael C. Dewan, Abbas Rattani, Ronnie E. Baticulon, Serena Faruque, Walter D. Johnson, Robert J. Dempsey, Michael M. Haglund, Blake C. Alkire, Kee B. Park, Benjamin C. Warf, and Mark G. Shrime

OBJECTIVE

The global magnitude of neurosurgical disease is unknown. The authors sought to estimate the surgical and consultative proportion of diseases commonly encountered by neurosurgeons, as well as surgeon case volume and perceived workload.

METHODS

An electronic survey was sent to 193 neurosurgeons previously identified via a global surgeon mapping initiative. The survey consisted of three sections aimed at quantifying surgical incidence of neurological disease, consultation incidence, and surgeon demographic data. Surgeons were asked to estimate the proportion of 11 neurological disorders that, in an ideal world, would indicate either neurosurgical operation or neurosurgical consultation. Respondent surgeons indicated their confidence level in each estimate. Demographic and surgical practice characteristics—including case volume and perceived workload—were also captured.

RESULTS

Eighty-five neurosurgeons from 57 countries, representing all WHO regions and World Bank income levels, completed the survey. Neurological conditions estimated to warrant neurosurgical consultation with the highest frequency were brain tumors (96%), spinal tumors (95%), hydrocephalus (94%), and neural tube defects (92%), whereas stroke (54%), central nervous system infection (58%), and epilepsy (40%) carried the lowest frequency. Similarly, surgery was deemed necessary for an average of 88% cases of hydrocephalus, 82% of spinal tumors and neural tube defects, and 78% of brain tumors. Degenerative spine disease (42%), stroke (31%), and epilepsy (24%) were found to warrant surgical intervention less frequently. Confidence levels were consistently high among respondents (lower quartile > 70/100 for 90% of questions), and estimates did not vary significantly across WHO regions or among income levels. Surgeons reported performing a mean of 245 cases annually (median 190). On a 100-point scale indicating a surgeon’s perceived workload (0—not busy, 100—overworked), respondents selected a mean workload of 75 (median 79).

CONCLUSIONS

With a high level of confidence and strong concordance, neurosurgeons estimated that the vast majority of patients with central nervous system tumors, hydrocephalus, or neural tube defects mandate neurosurgical involvement. A significant proportion of other common neurological diseases, such as traumatic brain and spinal injury, vascular anomalies, and degenerative spine disease, demand the attention of a neurosurgeon—whether via operative intervention or expert counsel. These estimates facilitate measurement of the expected annual volume of neurosurgical disease globally.

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Paul Sean Echlin, Charles H. Tator, Michael D. Cusimano, Robert C. Cantu, Jack E. Taunton, Ross E. G. Upshur, Michael Czarnota, Craig R. Hall, Andrew M. Johnson, Lorie A. Forwell, Molly Driediger, and Elaine N. Skopelja

Object

The authors investigated return-to-play duration for initial and recurrent concussion in the same season in 2 teams of junior (16–21-year-old) ice hockey players during a regular season.

Methods

The authors conducted a prospective cohort study during 1 junior regular season (2009–2010) of 67 male fourth-tier ice hockey players (mean age 18.2 ± 1.2 years [SD], range 16–21 years) from 2 teams.

Prior to the start of the season, every player underwent baseline assessments that were determined using the Sideline Concussion Assessment Tool 2 (SCAT2) and the Immediate Post-Concussion Assessment and Cognitive Test (ImPACT). The study protocol also required players who entered the study during the season to complete a baseline SCAT2 and ImPACT. If the protocol was not followed, the postinjury test results of a player without true baseline test results were compared with previously established age- and sex-matched group normative levels.

Each game was directly observed by a physician and at least 1 neutral nonphysician observer. Players suspected of suffering a concussion were evaluated by the physician during the game. If a concussion was diagnosed, the player underwent clinical evaluation at the physician's office within 24 hours.

The return-to-play decision was based on clinical evaluation guided by the Zurich return-to-play protocol (contained in the consensus statement of international expert opinion at the 3rd International Conference on Concussion in Sport held in Zurich, November 2008). This clinical evaluation and return-to-play protocol was augmented by the 2 tests (SCAT2 and ImPACT) also recommended by the Zurich consensus statement, for which baseline values had been obtained.

Results

Seventeen players sustained a physician-observed or self-reported, physician-diagnosed concussion during a physician-observed ice hockey game. The mean clinical return-to-play duration (in 15 cases) was 12.8 ± 7.02 days (median 10 days, range 7–29 days); the mean number of physician office visits by players who suffered a concussion (15 cases) was 2.1 ± 1.29 (median 1.5 visits). Five of the 17 players who sustained a concussion also suffered a recurrent or second concussion. One of the 5 individuals who suffered a repeat concussion sustained his initial concussion in a regular season game that was not observed by a physician, and as a result this single case was not included in the total of 21 concussions. This initial concussion of the player was identified during baseline testing 2 days after the injury and was subsequently medically diagnosed and treated. The mean interval between the first and second concussions in these 5 players was 78.6 ± 39.8 days (median 82 days), and the mean time between the return-to-play date of the first and second concussions was 61.8 ± 39.7 days (median 60 days).

Conclusions

The mean rates of return to play for single and recurrent concussions were higher than rates cited in recent studies involving sport concussions. The time interval between the first and second concussions was also greater than previously cited. This difference may be the result of the methodology of direct independent physician observation, diagnosis, and adherence to the Zurich return-to-play protocol.

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Bizhan Aarabi, James S. Harrop, Charles H. Tator, Melvin Alexander, Joseph R. Dettori, Robert G. Grossman, Michael G. Fehlings, Stuart E. Mirvis, Kathirkamanathan Shanmuganathan, Katie M. Zacherl, Keith D. Burau, Ralph F. Frankowski, Elizabeth Toups, Christopher I. Shaffrey, James D. Guest, Susan J. Harkema, Nader M. Habashi, Penny Andrews, Michele M. Johnson, and Michael K. Rosner

Object

Pulmonary complications are the most common acute systemic adverse events following spinal cord injury (SCI), and contribute to morbidity, mortality, and increased length of hospital stay (LOS). Identification of factors associated with pulmonary complications would be of value in prevention and acute care management. Predictors of pulmonary complications after SCI and their effect on neurological recovery were prospectively studied between 2005 and 2009 at the 9 hospitals in the North American Clinical Trials Network (NACTN).

Methods

The authors sought to address 2 specific aims: 1) define and analyze the predictors of moderate and severe pulmonary complications following SCI; and 2) investigate whether pulmonary complications negatively affected the American Spinal Injury Association (ASIA) Impairment Scale conversion rate of patients with SCI. The NACTN registry of the demographic data, neurological findings, imaging studies, and acute hospitalization duration of patients with SCI was used to analyze the incidence and severity of pulmonary complications in 109 patients with early MR imaging and long-term follow-up (mean 9.5 months). Univariate and Bayesian logistic regression analyses were used to analyze the data.

Results

In this study, 86 patients were male, and the mean age was 43 years. The causes of injury were motor vehicle accidents and falls in 80 patients. The SCI segmental level was in the cervical, thoracic, and conus medullaris regions in 87, 14, and 8 patients, respectively. Sixty-four patients were neurologically motor complete at the time of admission. The authors encountered 87 complications in 51 patients: ventilator-dependent respiratory failure (26); pneumonia (25); pleural effusion (17); acute lung injury (6); lobar collapse (4); pneumothorax (4); pulmonary embolism (2); hemothorax (2), and mucus plug (1). Univariate analysis indicated associations between pulmonary complications and younger age, sports injuries, ASIA Impairment Scale grade, ascending neurological level, and lesion length on the MRI studies at admission. Bayesian logistic regression indicated a significant relationship between pulmonary complications and ASIA Impairment Scale Grades A (p = 0.0002) and B (p = 0.04) at admission. Pulmonary complications did not affect long-term conversion of ASIA Impairment Scale grades.

Conclusions

The ASIA Impairment Scale grade was the fundamental clinical entity predicting pulmonary complications. Although pulmonary complications significantly increased LOS, they did not increase mortality rates and did not adversely affect the rate of conversion to a better ASIA Impairment Scale grade in patients with SCI. Maximum canal compromise, maximum spinal cord compression, and Acute Physiology and Chronic Health Evaluation–II score had no relationship to pulmonary complications.

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Karl G. Helmer, Ofer Pasternak, Eli Fredman, Ronny I. Preciado, Inga K. Koerte, Takeshi Sasaki, Michael Mayinger, Andrew M. Johnson, Jeffrey D. Holmes, Lorie A. Forwell, Elaine N. Skopelja, Martha E. Shenton, and Paul S. Echlin

Object

Concussion, or mild traumatic brain injury (mTBI), is a commonly occurring sports-related injury, especially in contact sports such as hockey. Cerebral microbleeds (CMBs), which appear as small, hypointense lesions on T2*-weighted images, can result from TBI. The authors use susceptibility-weighted imaging (SWI) to automatically detect small hypointensities that may be subtle signs of chronic and acute damage due to both subconcussive and concussive injury. The goal was to investigate how the burden of these hypointensities changes over time, over a playing season, and postconcussion, in comparison with subjects who did not suffer a medically observed and diagnosed concussion.

Methods

Images were obtained in 45 university-level adult male and female ice hockey players before and after a single Canadian Interuniversity Sports season. In addition, 11 subjects (5 men and 6 women) underwent imaging at 72 hours, 2 weeks, and 2 months after concussion. To identify subtle changes in brain tissue and potential CMBs, nonvessel clusters of hypointensities on SWI were automatically identified, and a hypointensity burden index was calculated for all subjects at the beginning of the season (BOS), the end of the season (EOS), and at postconcussion time points (where applicable).

Results

A statistically significant increase in the hypointensity burden, relative to the BOS, was observed for male subjects with concussions at the 2-week postconcussion time point. A smaller, nonsignificant rise in the burden for female subjects with concussions was also observed within the same time period. There were no significant changes in burden for nonconcussed subjects of either sex between the BOS and EOS time points. However, there was a statistically significant difference in the burden between male and female subjects in the nonconcussed group at both the BOS and EOS time points, with males having a higher burden.

Conclusions

This method extends the utility of SWI from the enhancement and detection of larger (> 5 mm) CMBs, which are often observed in more severe cases of TBI, to cases involving smaller lesions in which visual detection of injury is difficult. The hypointensity burden metric proposed here shows statistically significant changes over time in the male subjects. A smaller, nonsignificant increase in the burden metric was observed in the female subjects.

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Paul Sean Echlin, Charles H. Tator, Michael D. Cusimano, Robert C. Cantu, Jack E. Taunton, Ross E. G. Upshur, Craig R. Hall, Andrew M. Johnson, Lorie A. Forwell, and Elaine N. Skopelja

Object

The objective of this study was to measure the incidence of concussion (scaled relative to number of athlete exposures) and recurrent concussion within 2 teams of fourth-tier junior ice hockey players (16–21 years old) during 1 regular season.

Methods

A prospective cohort study called the Hockey Concussion Education Project was conducted during 1 junior ice hockey regular season (2009–2010) involving 67 male fourth-tier ice hockey players (mean age 18.2 ± 1.2 years, range 16–21 years) from 2 teams. Prior to the start of the season, every player underwent baseline assessments using the Sideline Concussion Assessment Tool 2 (SCAT2) and the Immediate Post-Concussion Assessment and Cognitive Test (ImPACT). The study protocol also required players who entered the study during the season to complete baseline SCAT2 and ImPACT testing. If the protocol was not followed, the postinjury test results of a player without true baseline test results would be compared against previously established age and gender group normative levels. Each regular season game was observed by a qualified physician and at least 1 other neutral nonphysician observer. Players who suffered a suspected concussion were evaluated at the game. If a concussion diagnosis was made, the player was subsequently examined in the physician's office for a full clinical evaluation and the SCAT2 and ImPACT were repeated. Based on these evaluations, players were counseled on the decision of when to return to play. Athlete exposure was defined as 1 game played by 1 athlete.

Results

Twenty-one concussions occurred during the 52 physician-observed games (incidence 21.5 concussions per 1000 athlete exposures). Five players experienced repeat concussions. No concussions were reported during practice sessions. A concussion was diagnosed by the physician in 19 (36.5%) of the 52 observed games. One of the 5 individuals who suffered a repeat concussion sustained his initial concussion in a regular season game that was not observed by a physician, and as a result this single case was not included in the total of 21 total concussions. This initial concussion of the player was identified during baseline testing 2 days after the injury and was subsequently medically diagnosed and treated.

Conclusions

The incidence of game-related concussions (per 100 athlete exposures) in these fourth-tier junior ice hockey players was 7 times higher than the highest rate previously reported in the literature. This difference may be the result of the use of standardized direct physician observation, diagnosis, and subsequent treatment. The results of this study demonstrate the need for follow-up studies involving larger and more diverse sample groups to reflect generalizability of the findings. These follow-up studies should involve other contact sports (for example football and rugby) and also include the full spectrum of gender, age, and skill levels.