Charles G. Fisher

Early versus Delayed Decompression for Traumatic Cervical Spinal Cord Injury: Results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS)

Background There is convincing preclinical evidence that early decompression in the setting of spinal cord injury (SCI) improves neurologic outcomes. However, the effect of early surgical decompression in patients with acute SCI remains uncertain. Our objective was to evaluate the relative effectiveness of early (<24 hours after injury) versus late (≥24 hours after injury) decompressive surgery after traumatic cervical SCI. Methods We performed a multicenter, international, prospective cohort study (Surgical Timing in Acute Spinal Cord Injury Study: STASCIS) in adults aged 16–80 with cervical SCI. Enrolment occurred between 2002 and 2009 at 6 North American centers. The primary outcome was ordinal change in ASIA Impairment Scale (AIS) grade at 6 months follow-up. Secondary outcomes included assessments of complications rates and mortality. Findings A total of 313 patients with acute cervical SCI were enrolled. Of these, 182 underwent early surgery, at a mean of 14.2(±5.4) hours, with the remaining 131 having late surgery, at a mean of 48.3(±29.3) hours. Of the 222 patients with follow-up available at 6 months post injury, 19.8% of patients undergoing early surgery showed a ≥2 grade improvement in AIS compared to 8.8% in the late decompression group (OR = 2.57, 95% CI:1.11,5.97). In the multivariate analysis, adjusted for preoperative neurological status and steroid administration, the odds of at least a 2 grade AIS improvement were 2.8 times higher amongst those who underwent early surgery as compared to those who underwent late surgery (OR = 2.83, 95% CI:1.10,7.28). During the 30 day post injury period, there was 1 mortality in both of the surgical groups. Complications occurred in 24.2% of early surgery patients and 30.5% of late surgery patients (p = 0.21). Conclusion Decompression prior to 24 hours after SCI can be performed safely and is associated with improved neurologic outcome, defined as at least a 2 grade AIS improvement at 6 months follow-up.

A novel classification system for spinal instability in neoplastic disease: an evidence-based approach and expert consensus from the Spine Oncology Study Group.

Study Design. Systematic review and modified Delphi technique. Objective. To use an evidence-based medicine process using the best available literature and expert opinion consensus to develop a comprehensive classification system to diagnose neoplastic spinal instability. Summary of Background Data. Spinal instability is poorly defined in the literature and presently there is a lack of guidelines available to aid in defining the degree of spinal instability in the setting of neoplastic spinal disease. The concept of spinal instability remains important in the clinical decision-making process for patients with spine tumors. Methods. We have integrated the evidence provided by systematic reviews through a modified Delphi technique to generate a consensus of best evidence and expert opinion to develop a classification system to define neoplastic spinal instability. Results. A comprehensive classification system based on patient symptoms and radiographic criteria of the spine was developed to aid in predicting spine stability of neoplastic lesions. The classification system includes global spinal location of the tumor, type and presence of pain, bone lesion quality, spinal alignment, extent of vertebral body collapse, and posterolateral spinal element involvement. Qualitative scores were assigned based on relative importance of particular factors gleaned from the literature and refined by expert consensus. Conclusion. The Spine Instability Neoplastic Score is a comprehensive classification system with content validity that can guide clinicians in identifying when patients with neoplastic disease of the spine may benefit from surgical consultation. It can also aid surgeons in assessing the key components of spinal instability due to neoplasia and may become a prognostic tool for surgical decision-making when put in context with other key elements such as neurologic symptoms, extent of disease, prognosis, patient health factors, oncologic subtype, and radiosensitivity of the tumor.

The subaxial cervical spine injury classification system: a novel approach to recognize the importance of morphology, neurology, and integrity of the disco-ligamentous complex.

Study Design. The classification system was derived through a literature review and expert opinion of experienced spine surgeons. In addition, a multicenter reliability and validity study of the system was conducted on a collection of trauma cases. Objectives. To define a novel classification system for subaxial cervical spine trauma that conveys information about injury pattern, severity, treatment considerations, and prognosis. To evaluate reliability and validity of this system. Summary of Background Data. Classification of subaxial cervical spine injuries remains largely descriptive, lacking standardization and prognostic information. Methods. Clinical and radiographic variables encountered in subaxial cervical trauma were identified by a working section of the Spine Trauma Study Group. Significant limitations of existing systems were defined and addressed within the new system. This system, as well as the Harris and Ferguson & Allen systems, was applied by 20 spine surgeons to 11 cervical trauma cases. Six weekslater, the cases were randomly reordered and again scored. Interrater reliability, intrarater reliability, and validity were assessed. Results. Each of 3 main categories (injury morphology, disco-ligamentous complex, and neurologic status) identified as integrally important to injury classification was assigned a weighted score; the injury severity score was obtained by summing the scores from each category. Treatment options were assigned based on threshold values of the severity score. Interrater agreement as assessed by intraclass correlation coefficient of the DLC, morphology, and neurologic status scores was 0.49, 0.57, and 0.87, respectively. Intrarater agreement as assessed by intraclass correlation coefficient of the DLC, morphology, and neurologic status scores was 0.66, 0.75, and 0.90, respectively. Raters agreed with treatment recommendations of the algorithm in 93.3% of cases, suggesting high construct validity. The reliability compared favorably to the Harris and Ferguson & Allen systems. Conclusion. The Sub-axial Injury Classification and Severity Scale provides a comprehensive classification system for subaxial cervical trauma. Early validity and reliability data are encouraging.

Spinal Instability Neoplastic Score: An Analysis of Reliability and Validity From the Spine Oncology Study Group

PURPOSE Standardized indications for treatment of tumor-related spinal instability are hampered by the lack of a valid and reliable classification system. The objective of this study was to determine the interobserver reliability, intraobserver reliability, and predictive validity of the Spinal Instability Neoplastic Score (SINS). METHODS Clinical and radiographic data from 30 patients with spinal tumors were classified as stable, potentially unstable, and unstable by members of the Spine Oncology Study Group. The median category for each patient case (consensus opinion) was used as the gold standard for predictive validity testing. On two occasions at least 6 weeks apart, each rater also scored each patient using SINS. Each total score was converted into a three-category data field, with 0 to 6 as stable, 7 to 12 as potentially unstable, and 13 to 18 as unstable. RESULTS The κ statistics for interobserver reliability were 0.790, 0.841, 0.244, 0.456, 0.462, and 0.492 for the fields of location, pain, bone quality, alignment, vertebral body collapse, and posterolateral involvement, respectively. The κ statistics for intraobserver reliability were 0.806, 0.859, 0.528, 0.614, 0.590, and 0.662 for the same respective fields. Intraclass correlation coefficients for inter- and intraobserver reliability of total SINS score were 0.846 (95% CI, 0.773 to 0.911) and 0.886 (95% CI, 0.868 to 0.902), respectively. The κ statistic for predictive validity was 0.712 (95% CI, 0.676 to 0.766). CONCLUSION SINS demonstrated near-perfect inter- and intraobserver reliability in determining three clinically relevant categories of stability. The sensitivity and specificity of SINS for potentially unstable or unstable lesions were 95.7% and 79.5%, respectively.

Diagnosis and management of metastatic spine disease: A review

With continued growth of the elderly population and improvements in cancer therapies, the number of patients with symptomatic spinal metastases is likely to increase, and this is a condition that commonly leads to debilitating neurological dysfunction and pain. Advancements in surgical techniques of resection and spinal reconstruction, improvements in clinical outcomes following various treatment modalities, generally increased overall survival in patients with metastatic spine disease, and a recent randomized trial by Patchell and colleagues demonstrating the superiority of a combined surgical/radiotherapeutic approach over a radiotherapy-only strategy have led many to suggest increasingly aggressive interventions for patients with such lesions. Optimal management of spinal metastases encompasses numerous medical specialties, including neurosurgery, orthopedic surgery, medical and radiation oncology, radiology, and rehabilitation medicine. In this review, the clinical presentation, diagnosis, and management of spinal metastatic disease are discussed. Ultimately, the goal of treatment in patients with spinal metastases remains palliative, and clinical judgment is required to select the appropriate patients for surgical intervention.

Impact of surgical intervention on quality of life in patients with spinal metastases.

Study Design. Prospective clinical study. Objective. To assess Health-Related Quality of Life outcomes in patients undergoing surgery for spinal metastases. Summary of Background Data. Increasing life expectancy of patients with spinal metastases has resulted in greater interest in overall quality of life, including pain and neurologic impairment. To assess the overall risks and benefits of surgical intervention, the overall impact of each on the overall health status must be assessed. Methods. All patients who presented to a single institution with bony spinal metastases requiring surgical intervention were eligible. Exclusion criteria: previous surgery for spinal metastases, primary tumors of the spine, and inability to fill out the questionnaires. Patients completed an EORTC QLQ-C30, the HUI-3, the EQ-5D, visual analog pain, and an ECOG functional assessment. at five points: before surgery and at 6 weeks, 3 months, 6 months, and 1 year post surgery. Results. Of 96 patients who presented to the hospital, 85 were enrolled in the study. Average age was 58.6 years (range, 20.3–80.7 years) with 47 male patients; 50% survival as 39.1 weeks. Maximal and average VAS pain levels showed a statistically significant (P < 0.00001) improvement from preoperative to all postoperative time points. Only the QLQ-C30 global health status showed a statistically significant improvement from preoperative to the 6-week (P = 0.017), 3-month (P = 0.039), and 6-month (P = 0.013) time points. There was a statistically significant correlation between baseline global health status and survival time (P = 0.041). Overall distribution of HUI-3 utility calculated Quality of Life Adjusted Years (QALY) during the 1-year postoperative period showed a bimodal distribution with peaks at 0.1 and 0.7 years. Conclusions. Surgery for patients with spinal metastases offers decreased pain and improved quality of life with low rates of surgical complications.

Radiographic measurement parameters in thoracolumbar fractures: a systematic review and consensus statement of the spine trauma study group.

Study Design. Systematic review. Objectives. To review the various radiographic parameters currently used to assess traumatic thoracolumbar injuries, emphasizing the validity and technique behind each one, to formulate evidence-based guidelines for a standardized radiographic method of assessment of these fractures. Summary of Background Data. The treatment of thoracolumbar fractures is guided by various radiographic measurement parameters. Unfortunately, for each group of parameters, there has usually been more than 1 proposed measurement technique, thus creating confusion when gathering data and reporting outcomes. Ultimately, this effect results in clinical decisions being based on nonstandardized, nonvalidated outcome measures. Methods. Computerized bibliographic databases were searched up to January 2004 using key words and Medical Subject Headings on thoracolumbar spine trauma, radiographic parameters, and methodologic terms. Using strict inclusion criteria, 2 independent reviewers conducted study selection, data abstraction, and methodologic quality assessment. Results. There were 18 original articles that ultimately constituted the basis for the review. Of radiographic measurement parameters, 3 major groups were identified, depicting the properties of the injured spinal column: sagittal alignment, vertebral body compression, and spinal canal dimensions, with 14 radiographic parameters reported to assess these properties. Conclusions. Based on a systematic review of theliterature and expert opinion from an experienced group of spine trauma surgeons, it is recommended that the following radiographic parameters should be used routinely to assess thoracolumbar fractures: the Cobb angle, to assess sagittal alignment; vertebral body translation percentage, to express traumatic anterolisthesis; anterior vertebral body compression percentage, to assess vertebral body compression, the sagittal-to-transverse canal diameter ratio, and canal total cross-sectional area (measured or calculated); and the percent canal occlusion, to assess canal dimensions.

The surgical approach to subaxial cervical spine injuries: an evidence-based algorithm based on the SLIC classification system.

Study Design. Systematic review of literature and expert clinical opinions of the members of the Spine Trauma Study Group were combined to develop and refine this algorithm. Obejctive. To develop an evidence-based algorithm for surgical approaches to manage subaxial cervical injuries using a systematic review of the literature, expert opinion, and anticipated patient preferences. Summary of Background Data. There is lack of consensus in the management of subaxial cervical spine trauma, in part, because of the lack of a clinically relevant system for classifying these injuries. The newly developed Subaxial Injury Classification scoring system categorizes injury morphology into 3 broad groups, includes an assessment of the integrity of the discoligamentous soft tissue structures and the patients neurologic status, and thus guides surgical or nonsurgical treatment. The choice of a specific surgical technique and approach is currently not evidence based, and this gap in knowledge is one which the current article seeks to address. Methods. A literature review followed by a consensus of experts approach was used to develop the algorithm and to ensure face and content validity. Results. An algorithm is presented to guide the choice of surgical approach in cervical subaxial burst fractures, distraction injuries, and translation or rotation injuries. The burst or compression injuries and distraction injuries are more likely to be treated with a single anterior approach, whereas the more severe translation or rotation injuries may more commonly be approached posteriorly or with combined anterior and posterior surgery. Conclusion. This algorithm; derived from the Subaxial Injury Classification scoring system, will assist surgeons in answering the 2 most common questions they face when managing subaxial cervical spine trauma: “Should I operate?” and “Which surgical approach should I select?”

Morbidity and mortality of major adult spinal surgery. A prospective cohort analysis of 942 consecutive patients

BACKGROUND CONTEXT To date, most reports on the incidence of adverse events (AEs) in spine surgery have been retrospective and dependent on data abstraction from hospital-based administrative databases. To our knowledge, there have been no previous rigorously performed prospective analysis of all AEs occurring in the entire population of patients presenting to an academic quaternary referral center. PURPOSE To determine the mortality and true incidence and severity of morbidity (major and minor, medical and surgical) in adults undergoing complex spinal surgery, both trauma and elective, in a quaternary referral center. To examine the influence of the introduction of a dedicated weekly multidisciplinary rounds, and a formal abstraction tool, on the recording of this prospective perioperative morbidity data. To examine the validity and inter- and intraobserver reliability of a dedicated Spine AdVerse Events Severity system, version 2 (SAVES V2) AE abstraction tool. STUDY DESIGN Ours is an academic quaternary referral center serving a population of 4.5 million people. Beginning in April 2008, a spine-specific AE-recording instrument, entitled SAVES V2, was introduced at our center for reporting, categorization, and classification of AEs. The use of this system remains an ongoing prospective study. PATIENT SAMPLE All adult patients admitted to the spine service of a quaternary referral center for a 12-month period. OUTCOME MEASURES A validity and an inter- and intraobserver reliability examination of the SAVES V2 system, as used at our institution. Morbidity and inhospital deaths, unplanned second surgeries during index admission, wound infections requiring reoperation, and readmissions during the same calendar year. We also examined in detail all intraoperative and nonsurgical postoperative AEs, as well as hospital length of stay (LOS). METHODS Data on all patients undergoing surgery over a 12-month period were prospectively collected using a perioperative morbidity abstraction tool at weekly dedicated mortality and morbidity rounds. This tool allows identification of each specific AE and grades the severity. Before the introduction of this system, and using the hospital inpatient database, our documented perioperative morbidity rate (major and minor, medical and surgical) was 23%. Diagnosis, operative data, hospital data, major and minor complications both medical and surgical, and deaths were recorded. RESULTS One hundred percent of all patients discharged from the unit had complete data available for analysis. Nine hundred forty-two patients with an age range of 16 to 90 years (mean, 54 years; mode, 38 years) were identified. There were 552 males and 390 females. Around 58.5% of patients had undergone elective surgery. Thirty percent of patients were American Spinal Injury Association class D or worse on admission. The average LOS was 13.5 days (range, 1-221 days). Eight hundred twenty-two (87%) patients had at least one documented complication. Thirty-nine percent of these adversely affected hospital LOS. There were 14 mortalities during the study period. The rate of intraoperative surgical complication was 10.5% (4.5% incidental durotomy and 1.9% hardware malposition requiring revision and 2.2% blood loss >2 L). The incidence of postoperative complication was 73.5% (wound complications, 13.5%; delerium, 8%; pneumonia, 7%; neuropathic pain, 5%; dysphagia, 4.5%; and neurological deterioration, 3%). CONCLUSIONS Major spinal surgery in the adult is associated with a high incidence of intra- and postoperative complications. We identified a very high rate of previously unrecognized postoperative complications, which adversely affect LOS. Without strict adherence to a prospective data collection system, the true complexity of this surgery may be greatly underestimated.

Factors predicting motor recovery and functional outcome after traumatic central cord syndrome: a long-term follow-up.

Study Design. A prospectively maintained database-generated retrospective review and cross-sectional outcome analysis was performed at a single academic center. Objectives. To assess the improvement in ASIA motor score (AMS) and secondarily to assess generic health related quality of life (HRQoL) and functional status; correlating these with variables that may predict outcome. Summary of Background Data. Many variables are potential contributors to motor recovery, patient function, and outcome following cervical trauma. Studies often suffer from low power, short follow-up, heterogeneous cohorts, and use of outcome instruments that are neither valid nor psychometrically sound. Methods. AMS were collected within 72 hours of the time of injury and again at follow-up by trained examiners. The SF-36 and FIM were administered to all patients at follow-up. Results. AMS improved from a mean of 58.7 at injury to a mean of 92.3 at follow-up. Bowel and bladder continence was reported by 81% while independent ambulation was reported by 86%. Final AMS was positively correlated with the AMS at injury, formal education, and presence of spasticity at follow-up. Functional status (FIM) was positively correlated with higher AMS at injury, formal education, absence of comorbidities, absence of spasticity, and younger age. Generic HRQoL outcomes (SF-36) were improved in individuals with more formal education, fewer comorbidities, absence of spasticity, and anterior column fractures. Conclusions. Although the majority of patients improve to an AMS between 90 and 100, many have significant disability and are less functional than the general population. Significant predictive variables include the initial motor score, formal education, comorbidities, ageat injury, and development of spasticity. An assessment of more than just the motor score is required to obtain an appreciation of the function and outcomes in this population.