Shane Burch

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.

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.

Predictive factors for proximal junctional kyphosis in long fusions to the sacrum in adult spinal deformity

Study Design. A retrospective study. Objective. To assess the mechanisms and the independent risk factors associated with proximal junctional kyphosis (PJK) in patients treated surgically for adult spinal deformity with long fusions to the sacrum. Summary of Background Data. The occurrence of PJK may be related to preoperative and postoperative sagittal parameters. The mechanisms and risk factors for PJK in adults are not well defined. Methods. Consecutive patients who underwent long instrumented fusion surgery (≥6 vertebrae) to the sacrum with a minimum of 2 years of follow-up were retrospectively studied. Risk factors included patient factors, surgical factors, and radiographical parameters such as thoracic kyphosis (TK), lumbar lordosis (LL), sagittal vertical axis, pelvic tilt, and pelvic incidence. Results. Ninety consecutive patients (mean age, 64.5 yr) met inclusion criteria. Radiographical PJK occurred in 37 of the 90 (41%) patients with a mean follow-up of 2.9 years. The most common mechanism of PJK was fracture at the upper instrumented vertebra (UIV) in 19 (51%) patients. Twelve (13%) patients with PJK were treated surgically with proximal extension of the instrumented fusion. Preoperative TK more than 30°, preoperative proximal junctional angle more than 10°, change in LL more than 30°, and pelvic incidence more than 55° were identified as predictors associated with PJK. Achievement of ideal global sagittal realignment (sagittal vertical axis <50 mm, pelvic tilt <20°, and pelvic incidence-LL <±10°) protected against the development of PJK (19% vs. 45%). A multivariate regression analysis revealed changes in LL more than 30°, and preoperative TK more than 30° were the independent risk factors associated with PJK. Conclusion. Fracture at the UIV was the most common mechanism for PJK. Change in LL more than 30° and pre-existing TK more than 30° were identified as independent risk factors. Optimal postoperative alignment of the spine protects against the development of PJK. A surgical strategy to minimize PJK may include preoperative planning for reconstructions with a goal of optimal postoperative alignment. Level of Evidence: 3

Shifting Paradigms in the Treatment of Metastatic Spine Disease

Study Design. Systematic review and evidence appraisal. Objective. To evaluate the optimal treatment for patients with spinal cord compression secondary to solid metastases and in patients with solitary renal metastases, without spinal cord compression. Methods. Focused Medline and OVID database searches were conducted using relevant keywords. Only clinical articles that evaluated specific end points of interest were included in the literature review. The quality of evidence provided by each article was assessed using the ATS guidelines. The expert opinion was synthesized based on the evidence and rated as strong or weak, depending on the quality of the supporting literature. Results. Twelve surgical and 7 radiation clinical series were identified that evaluated post-treatment ambulation in patients with metastatic spinal cord compression. Only 1 surgical article met the criteria for moderate quality evidence while the remaining surgical and radiation articles presented very low quality of evidence. All articles that evaluated treatment of solitary renal metastases presented very low quality of evidence. Conclusion. A strong recommendation is made for patients with high-grade cord compression due to solid tumor metastases to undergo surgical decompression with stabilization followed by radiation therapy. A weak recommendation is made for patients with solitary renal metastases without spinal cord compression to undergo spinal stereotactic radiosurgery.

Use of C-reactive protein after spinal surgery: comparison with erythrocyte sedimentation rate as predictor of early postoperative infectious complications.

Study Design. This is a prospective observational study of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) in a cohort of patients undergoing spinal surgery. Objective. We sought to characterize the normal kinetics of ESR and CRP after spinal surgery and compare their usefulness as predictors of infectious complications in the early postoperative period. Summary of Background Data. ESR and CRP are nonspecific markers of inflammation used to evaluate postoperative infection. CRP is a quantitative test that exhibits predictable kinetics consisting of a postoperative rise and a peak followed by a decrease toward the normal value. Deviation from normal kinetics may be an indicator of infection. Methods. ESR and CRP were collected before surgery and daily after surgery in consecutive patients. All infectious complications were recorded. Results. One hundred forty-nine patients met inclusion criteria. Infectious complications occurred in 20 patients. A postoperative peak, which is necessary to apply the test, was observed in 78% of patients for CRP and 48% for ESR. Multiple linear regression analysis revealed preoperative CRP, number of levels, and lumbar region as significant predictors of greater CRP peak value (r2 = 0.435, P = 0.001). After the peak, CRP showed an exponential decrease with a half-life of 2.6 days (r2 = 0.701, P < 0.001). No trend could be determined for ESR. A second rise or failure to decrease as expected had a sensitivity, specificity, positive predictive value, and negative predictive value of 82%, 48%, 41%, and 86% for infectious complications, respectively. Of 8 cases of deep wound infection, 7 exhibited substantial deviations from expected CRP values. Conclusion. CRP is more applicable, predictable, and responsive in the early postoperative period compared with ESR. The postoperative kinetics of CRP derived in this study seems to be conserved regardless of operation, magnitude, or region. Knowledge of the kinetics allows assessment of the degree of difference between actual and expected values. Using a second rise or failure to decrease as expected for CRP is sensitive for infection. A negative test is reassuring that infection is unlikely.

Surgical site infection in spinal surgery: description of surgical and patient-based risk factors for postoperative infection using administrative claims data.

Study Design. Retrospective analysis. Objective. The objective of this study was to investigate the accuracy of using an automated approach to administrative claims data to assess the rate and risk factors for surgical site infection (SSI) in spinal procedures. Summary of Background Data. SSI is a major indicator of health care quality. A wide range of SSI rates have been proposed in the literature depending on clinical setting and procedure type. Methods. All spinal surgeries performed at a university-affiliated tertiary-care center from July 2005 to December 2010 were identified using diagnosis-related group, current procedural terminology, and International Classification of Diseases, Ninth Revision (ICD-9) codes and were validated through chart review. Rates of SSI and associated risk factors were calculated using univariate regression analysis. Odds ratios were calculated through multivariate logistic regression. Results. A total of 6628 hospital visits were identified. The cumulative incidence of SSI was 2.9%. Procedural risk factors associated with a statistically significant increase in rates of infection were the following: sacral involvement (9.6%), fusions greater than 7 levels (7.8%), fusions greater than 12 levels (10.4%), cases with an osteotomy (6.5%), operative time longer than 5 hours (5.1%), transfusions of red blood cells (5.0%), serum (7.4%), and autologous blood (4.1%). Patient-based risk factors included anemia (4.3%), diabetes mellitus (4.2%), coronary artery disease (4.7%), diagnosis of coagulopathy (7.8%), and bone or connective tissue neoplasm (5.0%). Conclusion. Used individually, diagnosis-related group, current procedural terminology, and ICD-9 codes cannot completely capture a patient population. Using an algorithm combining all 3 coding systems to generate both inclusion and exclusion criteria, we were able to analyze a specific population of spinal surgery patients within a high-volume medical center. Within that group, risk factors found to increase infection rates were isolated and can serve to focus hospital-wide efforts to decrease surgery-related morbidity and improve patient outcomes.

Pre-clinical in vitro and in vivo studies to examine the potential use of photodynamic therapy in the treatment of osteomyelitis

Osteomyelitis can lead to severe morbidity and even death resulting from an acute or chronic inflammation of the bone and contiguous structures due to fungal or bacterial infection. Incidence approximates 1 in 1000 neonates and 1 in 5000 children in the United States annually and increases up to 0.36% and 16% in adults with diabetes or sickle cell anaemia, respectively. Current regimens of treatment include antibiotics and/or surgery. However, the increasing number of antibiotic resistant pathogens suggests that alternate strategies are required. We are investigating photodynamic therapy (PDT) as one such alternate treatment for osteomyelitis using a bioluminescent strain of biofilm-producing staphylococcus aureus (S. aureus) grown onto kirschner wires (K-wire). S. aureus-coated K-wires were exposed to methylene blue (MB) or 5-aminolevulinic acid (ALA)-mediated PDT either in vitro or following implant into the tibial medullary cavity of Sprague-Dawley rats. The progression of S. aureus biofilm was monitored non-invasively using bioluminescence and expressed as a percentage of the signal for each sample immediately prior to treatment. S. aureus infections were subject to PDT 10 days post inoculation. Treatment comprised administration of ALA (300 mg kg−1) intraperitoneally followed 4 h later by light (635 ± 10 nm; 75 J cm−2) delivered transcutaneously via an optical fiber placed onto the tibia and resulted in significant delay in bacterial growth. In vitro, MB and ALA displayed similar cell kill with ≥4log10 cell kill. In vivo, ALA-mediated PDT inhibited biofilm implants in bone. These results confirm that MB or ALA-mediated PDT have potential to treat S. aureus cultures grown in vitro or in vivo using an animal model of osteomyelitis.

Hospital readmission after spine fusion for adult spinal deformity.

Study Design. Retrospective cohort study. Objective. To assess the rate, causes, and risk factors of unplanned hospital readmission after spine fusion for the treatment of adult spinal deformity. Summary of Background Data. Hospital readmissions in the elderly are common, and with increasing emphasis on the quality of health care, readmission rates are used to assess hospital performance. Spine surgery has seen rapidly increased utilization during the past 2 decades. Surgical treatments of complex spinal deformity are known to have higher rates of complications than other types of spine surgery. However, there are no reports describing the rates and causes of hospital readmission after deformity surgery. Methods. Patients were identified at a single institution from 2006 through 2011 that received a spine fusion for the treatment of adult spinal deformity. All hospital readmissions within 90 days of discharge were reviewed for cause. Unplanned readmission rates were calculated via Kaplan-Meier failure analysis. Rates were compared across patients receiving different lengths of spine fusion (short: 2–3 vertebra, medium: 4–8, long: 9 or more). Risk factors were assessed using a Cox proportional hazards multivariate model. Results. Eight hundred thirty-six patients were enrolled (111 short, 402 medium, and 323 long fusions). The overall unplanned readmission rate was 8.4% at 30 days and 12.3% at 90 days. Patients with long spine fusion had higher rates of readmission than patients with medium or short length fusions. Surgical site infection accounted for 45.6% of readmissions. Risk factors for readmission include longer fusion length, higher patient severity of illness, and specific medical comorbidities. Conclusion. Unplanned hospital readmissions after spine fusion for adult spinal deformity are common, and are most often due to surgical site infection. Patient medical comorbidities are an important part of assessing risk and can be used by providers and patients to better assess individual risk prior to treatment. Level of Evidence: 3

Intraoperative cone beam-computed tomography with navigation (O-ARM) versus conventional fluoroscopy (C-ARM): a cadaveric study comparing accuracy, efficiency, and safety for spinal instrumentation.

Study Design. Cadaveric laboratory study. Objective. To compare the accuracy, efficiency, and safety of intraoperative cone beam–computed tomography with navigation (O-ARM) with traditional intraoperative fluoroscopy (C-ARM) for the placement of pedicle screws. Summary of Background Data. Radiation exposure remains a concern with traditional methods of intraoperative imaging in spine surgery. The use of O-ARM has been proposed for more accurate and efficient spinal instrumentation. Understanding radiation imparted to patients and surgeons by O-ARM is important for assessing risks and benefits of this technology, especially in light of evolving indications. Methods. Four surgeons placed 160 pedicle screws on 8 cadavers without deformity. Eighty pedicle screws were placed using O-ARM and C-ARM each. Instrumentation was placed bilaterally in the thoracic (T1–T6) spine and lumbosacral junction (L5–S1) using a standard open technique, whereas minimally invasive surgery technique was used at the lumbar 3 to 4 (L3–L4) level. A “postoperative” computed tomography (CT) scan was performed on cadavers where instrumentation was done using the C-ARM. An independent musculoskeletal radiologist assessed final images for screw position. Time required to set up and instrumentation was recorded. Dosimeters were placed on multiple aspects of cadavers and surgeons to record radiation exposure. Results. There were no differences in breach rate between the O-ARM and C-ARM groups (5 vs. 7, &khgr;2= 0.63, P = 0.4). The setup time for the O-ARM group was longer than that for the C-ARM group (592 vs. 297 s, P < 0.05). However, the average total time was statistically the same (1629 vs. 1639 s, P = 0.96). Radiation exposure was higher for surgeons in the C-ARM group and cadavers in the O-ARM group. When a “postoperative” CT scan was included in the estimation of the total radiation exposure, there was less of difference between the groups, but still more for the O-ARM group. Conclusion. In cadavers without deformity, O-ARM use results in similar breach rates as C-ARM for the placement of pedicle screws. Time for instrumentation is shorter with the O-ARM, but requires a longer setup time. The O-ARM exposes less radiation to the surgeon, but higher doses to the cadaver. Level of Evidence: N/A

Proximal junctional kyphosis and clinical outcomes in adult spinal deformity surgery with fusion from the thoracic spine to the sacrum: a comparison of proximal and distal upper instrumented vertebrae

OBJECT Proximal junctional kyphosis (PJK) is a common and significant complication after corrective spinal deformity surgery. The object of this study was to compare-based on clinical outcomes, postoperative proximal junctional kyphosis rates, and prevalence of revision surgery-proximal thoracic (PT) and distal thoracic (DT) upper instrumented vertebra (UIV) in adults who underwent spine fusion to the sacrum for the treatment of spinal deformity. METHODS In this retrospective study the authors evaluated clinical and radiographic data from consecutive adults (age > 21 years) with a deformity treated using long instrumented posterior spinal fusion to the sacrum in the period from 2007 to 2009. The PT group included patients in whom the UIV was between T-2 and T-5, whereas the DT group included patients in whom the UIV level was between T-9 and L-1. Perioperative surgical data were compared between the PT and DT groups. Additionally, segmental, regional, and global spinal alignments, as well as the sagittal Cobb angle at the proximal junction, were analyzed on preoperative, early postoperative, and final standing 36-in. radiographs. Patient-reported outcome measurements (visual analog scale, Scoliosis Research Society Patient Questionnaire-22, Oswestry Disability Index, and the 36-Item Short-Form Health Survey) were compared. RESULTS Eighty-nine patients, 22 males and 67 females, had a minimum follow-up of 2 years, and thus were eligible for participation in this study. Sixty-seven patients were in the DT group and 22 were in the PT group. Operative time (p = 0.387) and estimated blood loss (p < 0.05) were slightly higher in the PT group. The overall rate of revision surgery was 48.0% and 54.5% in the DT and PT groups, respectively (p = 0.629). The prevalence of PJK according to radiological criteria was 34% in the DT group and 27% in the PT group (p = 0.609). The percent of patients with PJK that required surgical correction (surgical PJK) was 11.9% (8 of 67) in the DT group and 9.1% (2 of 22) in the PT group (p = 1.0). The onset of surgical PJK was significantly earlier than radiological PJK in the DT group (p < 0.01). The types of PJK were different in the PT and DT groups. Compression fracture at the UIV was more prevalent in the DT group, whereas subluxation was more prevalent in the PT group. Postoperatively, the PT group had less thoracic kyphosis (p = 0.02), less sagittal imbalance (p < 0.01), and less pelvic tilt (p = 0.04). In the DT group, early postoperative radiographs demonstrated that the proximal junctional angle of patients with surgical PJK was greater than in those without PJK and those with radiological PJK (p < 0.01). Clinical outcomes were significantly improved in both groups, and there was no significant difference between the groups. CONCLUSIONS Both PT and DT UIVs improve segmental and global sagittal plane alignment as well as patient-reported quality of life in those treated for adult spinal deformity. The prevalence of PJK was not different in the PT and DT groups. However, compression fracture was the mechanism more frequently observed with DT PJK, and subluxation was the mechanism more frequently observed in PT PJK. Strategies to avoid PJK may include vertebral augmentation to prevent fracture at the DT spine and mechanical means to prevent vertebral subluxation at the PT spine.