Christopher I. Shaffrey and Justin S. Smith
Gregory C. Wiggins, Michael J. Rauzzino, Henry M. Bartkowski, Russ P. Nockels and Christopher I. Shaffrey
Object. The authors sought to analyze prospectively the outcome of surgery for complex spinal deformity in the pediatric and young adult populations.
Methods. The authors evaluate all pediatric and adolescent patients undergoing operative correction of complex spinal deformity from December 1997 through July 1999. No patient was lost to follow-up review (average 21.1 months). There were 27 consecutive pediatric and adolescent patients (3–20 years of age) who underwent 32 operations. Diagnoses included scoliosis (18 idiopathic, five nonidiopathic) and four severe kyphoscoliosis. Operative correction and arthrodesis were achieved via 21 posterior approaches (Cotrel-Dubousset-Horizon), seven anterior approaches (Isola or Kaneda Scoliosis System), and two combined approaches. Operative time averaged 358 minutes (range 115–620 minutes). Blood loss averaged 807 ml (range 100–2000 ml). Levels treated averaged 9.1 (range three–16 levels). There was a 54% average Cobb angle correction (range 6–82%). No case was complicated by the patient's neurological deterioration, loss of somatosensory evoked potential monitoring, cardiopulmonary disease, donor-site complication, or wound breakdown. There was one case of hook failure and one progression of deformity beyond the site of surgical instrumentation that required reoperation. There were 10 minor complications that did not significantly affect patient outcome. No patient received undirected banked blood products. There was a significant improvement in cosmesis, and no patient experienced continued pain postoperatively. All patients have been able to return to their preoperative activities.
Conclusions. Compared with other major neurosurgical operations, segmental instrumentation for pediatric and adolescent spinal deformity is a safe procedure with minimal morbidity and there is a low risk of needing to use allogeneic blood products.
Devon Hoover, Aruna Ganju, Christopher I. Shaffrey, Henry Bartkowski and Michael J. Rauzzino
Thomas J. Buell, Davis G. Taylor, Ching-Jen Chen, Christopher I. Shaffrey, Justin S. Smith and Shay Bess
Michael G. Fehlings and Randolph J. Gray
Surgical complications in adult spondylolisthesis
Michael G. Fehlings and Doron Rabin
Aaron J. Clark, Roxanna M. Garcia, Malla K. Keefe, Tyler R. Koski, Michael K. Rosner, Justin S. Smith, Joseph S. Cheng, Christopher I. Shaffrey, Paul C. McCormick and Christopher P. Ames
Adult spinal deformity (ASD) surgery is increasing in the spinal neurosurgeon's practice.
A survey of neurosurgeon AANS membership assessed the deformity knowledge base and impact of current training, education, and practice experience to identify opportunities for improved education. Eleven questions developed and agreed upon by experienced spinal deformity surgeons tested ASD knowledge and were subgrouped into 5 categories: 1) radiology/spinopelvic alignment, 2) health-related quality of life, 3) surgical indications, 4) operative technique, and 5) clinical evaluation. Chi-square analysis was used to compare differences based on participant demographic characteristics (years of practice, spinal surgery fellowship training, percentage of practice comprising spinal surgery).
Responses were received from 1456 neurosurgeons. Of these respondents, 57% had practiced less than 10 years, 20% had completed a spine fellowship, and 32% devoted more than 75% of their practice to spine. The overall correct answer percentage was 42%. Radiology/spinal pelvic alignment questions had the lowest percentage of correct answers (38%), while clinical evaluation and surgical indications questions had the highest percentage (44%). More than 10 years in practice, completion of a spine fellowship, and more than 75% spine practice were associated with greater overall percentage correct (p < 0.001). More than 10 years in practice was significantly associated with increased percentage of correct answers in 4 of 5 categories. Spine fellowship and more than 75% spine practice were significantly associated with increased percentage correct in all categories. Interestingly, the highest error was seen in risk for postoperative coronal imbalance, with a very low rate of correct responses (15%) and not significantly improved with fellowship (18%, p = 0.08).
The results of this survey suggest that ASD knowledge could be improved in neurosurgery. Knowledge may be augmented with neurosurgical experience, spinal surgery fellowships, and spinal specialization. Neurosurgical education should particularly focus on radiology/spinal pelvic alignment, especially pelvic obliquity and coronal imbalance and operative techniques for ASD.
Michael P. Kelly, Lawrence G. Lenke, Jakub Godzik, Ferran Pellise, Christopher I. Shaffrey, Justin S. Smith, Stephen J. Lewis, Christopher P. Ames, Leah Y. Carreon, Michael G. Fehlings, Frank Schwab and Adam L. Shimer
The authors conducted a study to compare neurological deficit rates associated with complex adult spinal deformity (ASD) surgery when recorded in retrospective and prospective studies. Retrospective studies may underreport neurological deficits due to selection, detection, and recall biases. Prospective studies are expensive and more difficult to perform, but they likely provide more accurate estimates of new neurological deficit rates.
New neurological deficits were recorded in a prospective study of complex ASD surgeries (pSR1) with a defined outcomes measure (decrement in American Spinal Injury Association lower-extremity motor score) for neurological deficits. Using identical inclusion criteria and a subset of participating surgeons, a retrospective study was created (rSR1) and neurological deficit rates were collected. Continuous variables were compared with the Student t-test, with correction for multiple comparisons. Neurological deficit rates were compared using the Mantel-Haenszel method for standardized risks. Statistical significance for the primary outcome measure was p < 0.05.
Overall, 272 patients were enrolled in pSR1 and 207 patients were enrolled in rSR1. Inclusion criteria, defining complex spinal deformities, and exclusion criteria were identical. Sagittal Cobb measurements were higher in pSR1, although sagittal alignment was similar. Preoperative neurological deficit rates were similar in the groups. Three-column osteotomies were more common in pSR1, particularly vertebral column resection. New neurological deficits were more common in pSR1 (pSR1 17.3% [95% CI 12.6–22.2] and rSR1 9.0% [95% CI 5.0–13.0]; p = 0.01). The majority of deficits in both studies were at the nerve root level, and the distribution of level of injury was similar.
New neurological deficit rates were nearly twice as high in the prospective study than the retrospective study with identical inclusion criteria. These findings validate concerns regarding retrospective cohort studies and confirm the need for and value of carefully designed prospective, observational cohort studies in ASD.
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
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.
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.
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.
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.
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
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).
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).
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.
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.