Proceedings of the NASS 28th Annual Meeting / The Spine Journal 13 (2013) 1S–168S PATIENT SAMPLE: 1347 patients who underwent lumbar fusion surgery for degenerative spine conditions in a multi-surgeon spine specialty practice. OUTCOME MEASURES: SF-36, ODI and numeric rating scales (0 to 10) for back and leg pain. METHODS: The SF-36, ODI and rating scales for back and leg pain were administered prospectively to patients who had lumbar spine fusion. Data on 12 medical (diabetes, heart disease, DVT/PVD, hypertension, cancer, kidney disease, asthma, autoimmune diseases, osteoarthritis, osteoporosis, and stroke) and 5 psychosocial conditions (depression, anxiety, obesity, smoking status, and worker’s compensation status) were collected. A Generalized Linear Model (GLM) was created to test the impact of these comorbidities on the change in the ODI and SF-36 scores. RESULTS: There were 508 (38%) males and 252 (19%) smokers. Improvements in SF-36 PCS (6.7 at 1yr, 5.6 at 2yrs), SF-36 MCS (4.7 at 1yr, 4.8 at 2yrs), back pain (2.9 at 1yr, 2.4 at 2yrs), leg pain (2.7 at 1yr, 2.3 at 2yrs) and ODI (15.0 at 1yr, 14.1 at 2yrs) scores were seen. Age-adjusted correlations between these scales and the medical comorbidity scale were non-significant. Although statistically significant, the correlations for the psychosocial comorbidity scale and change in back pain scores at one (R5-0.13, p!0.0001) and two years (R5-0.13, p!0.0001) and change in SF-36 PCS scores at one year (R50.11, p50.0002) were weak. GLM showed that all point estimates to evaluate the impact of comorbidities and psychosocial conditions on the HRQOLs included 1.0 within their confidence intervals suggesting non-significance. Adjustments for levels of fusion surgery or ASA grade did not influence the R2 for any of the GLMs. CONCLUSIONS: Although the presence of psychosocial comorbidities may influence treatment success or failure, medical and psychosocial comorbidities did not dominate the effect of lumbar fusion on HRQOLs. This further validates the use of these measures as an assessment tool to determine treatment effects in patients undergoing lumbar fusion surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
41S
operating characteristic (ROC) analysis was performed. In order to assess the responsiveness of PRO instruments and their individual items, the difference between standardized response means (SRM) for responders vs non-responders was calculated. Health Transition Index and NASS Satisfaction were used as anchors. Correlation between items was assessed via Spearman rank. For PRO instruments and their items demonstrating high validity (AUC O0.70), and for individual items with similar dimensions and high correlation, items with maximum validity (AUC) were included in the final questionnaire, Vanderbilt Neck Index (VNI-6). RESULTS: NDI (AUC HTI: 0.72; NASS: 0.73; SRM diff: 0.97) and SF-12 PCS (AUC HTI: 0.66; NASS: 0.74; SRM diff: 0.63) were found to be most valid and responsive outcome measures as compared to SF12 MCS, EQ-5D, NRS-NP and NRS-AP (AUC#0.64; SRM diff #0.61). NDI and SF-12 PCS scores strongly correlated with each other (r50.61). For NDI, pain intensity, personal care, reading, sleep and recreation had highest AUC (O0.65). For SF-12 PCS, general health, less accomplishment and limitation due to pain and effect on usual work had the highest AUC (O0.65). Three of these nine most valid items were found to have significant correlation (r$0.52, p!0.0001) and inferior AUC values. Thus, six items from the 22-items assessed (personal care, reading, recreation, general health, accomplishment due to pain, effect on usual work) comprised our modified PRO, VNI-6. VNI-6 (AUC: 0.78; SRM diff: 1.15) demonstrated better validity and responsiveness than NDI (AUC: 0.72; SRM diff: 0.97) or SF-12 PCS (AUC: 0.66; SRM diff: 0.63) and strongly correlate with these much longer instruments: ODI (r50.81; p!0.0001) and SF-12 PCS (r50.80; p!0.0001). CONCLUSIONS: The 10-item NDI and 12-item SF-12 PCS were the most valid and responsive measures for assessing effectiveness of cervical surgery in our prospective registry. However, a more valid and responsive PRO instrument, VNI-6, can be constructed using 6 items. Large scale registry efforts can utilize this more feasible VNI-6, which has better validity and responsiveness than NDI and SF-12 PCS. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
http://dx.doi.org/10.1016/j.spinee.2013.07.128 http://dx.doi.org/10.1016/j.spinee.2013.07.129 82. A Novel Six-Item Outcome Instrument (VNI-6) for Assessing the Effectiveness of Cervical Surgery in Registry Efforts Saniya S. Godil, MD, Matthew J. McGirt, MD; Vanderbilt University Medical Center, Nashville, TN, US BACKGROUND CONTEXT: In the current era of health care reform, there is growing demand to measure real-world effectiveness and value of care. Prospective registries utilizing validated patient reported outcomes (PRO) have been promoted as the ideal platform to generate evidence to inform decision making. Validated PRO instruments for spinal disorders may be too lengthy to feasibly apply to large scale registry efforts, resulting in poor patient compliance. PURPOSE: We set out to 1) determine which PRO instruments are most valid and responsive after cervical surgery in a registry platform, and 2) to determine which items of these PRO instruments correlate most closely with patient perceived improvement as well as which domains have closest correlation (overlap). Our aim was to introduce a shorter and more feasible questionnaire for measuring effectiveness of cervical surgery with equal validity and responsiveness. STUDY DESIGN/SETTING: Prospective study. PATIENT SAMPLE: A total of 87 patients undergoing cervical spine surgery for cervical radiculopathy at a single medical institution. OUTCOME MEASURES: Patient reported outcomes [NRS-NP, NRSAP, NDI, SF-12 PCS, SF-12 MCS and EQ-5D]. METHODS: A total of 87 patients undergoing cervical spine surgery for cervical radiculopathy at a single medical institution were enrolled into our prospective registry. Baseline and one-year PROs [NRS-NP, NRS-AP, NDI, SF-12 PCS, SF-12 MCS and EQ-5D] were assessed. In order to assess the validity of PRO instruments and their individual items, receiver
83. Lumbar Spinal Stenosis Decompression Normalizes Free-Living Physical Activity Impairment Matthew Smuck, MD1, Matthew Buman, PhD2, Ma Agnes Ith, MD3, William Haskell4, Ming-Chih J. Kao5; 1Menlo Park, CA, US; 2Arizona State University, Phoenix, AZ, US; 3Stanford, Redwood City, CA, US; 4 Stanford University, Palo Alto, CA, US; 5Stanford University, Stanford, CA, US BACKGROUND CONTEXT: Impaired ambulation is a hallmark of spinal stenosis, yet objective assessment of activity tolerance outside the laboratory has evaded spine researchers. Accelerometers have advanced the knowledge of physical activity’s impact on various diseases and recently gained the attention of spine researchers. PURPOSE: The aim of this study was to compare baseline measures of physical activity in lumbar stenosis patients to controls, and to measures obtained 6-months post decompression surgery. STUDY DESIGN/SETTING: Prospective case-control study at a university spine center. PATIENT SAMPLE: 16 patients scheduled for lumbar stenosis decompression and 10 matched controls without spine or lower extremity complaints. OUTCOME MEASURES: Free-living physical activity monitoring using an accelerometer for 7 consecutive days (Actigraph GT3xþ), the selfpaced walking test (SPWT), and multiple validated self-reported measures: Swiss Spinal Stenosis Questionnaire, Neurogenic Claudication Outcome Score, Oswestry Disability Index, and SF-36. METHODS: Patients and controls completed all outcomes measures at baseline and patients repeated these measures 6-months post
Refer to onsite Annual Meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosures and FDA device/drug status at time of abstract submission.
42S
Proceedings of the NASS 28th Annual Meeting / The Spine Journal 13 (2013) 1S–168S
decompression. Differences between group means were evaluated using independent samples t-tests. RESULTS: At baseline, patients differed significantly (p!0.05) from controls in all self-reported measures, SPWT (time, distance, and speed), and multiple accelerometry thresholds in the sedentary and light ranges. At 6mo postop, significant differences persisted in the self-reported measures (except the SF-36 physical function and bodily pain subscales) while differences between patients and controls were no longer significant for SPWT (distance and speed) and accelerometry thresholds. CONCLUSIONS: Objective and self-reported measures provide different insights into the impact of lumbar spinal stenosis. Accelerometry measures in lumbar stenosis patients demonstrate differences primarily in the light activity range, relative to controls, with more robust normalization than self-report following surgical decompression. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. http://dx.doi.org/10.1016/j.spinee.2013.07.130
Thursday, October 10, 2013 4:10 – 5:10 PM Concurrent Session: Infection Management 84. Culture Profile of Surgical Site Infections after Topical Vancomycin Powder Use in Instrumented Spine Fusions Leah Y. Carreon, MD, MSc1, Jeffrey L. Gum, MD2, Charles H. Crawford, III, MD2, Lawrence G. Lenke, MD3, Jacob M. Buchowski, MD, MS4, Charles C. Edwards, MD5, Steven D. Glassman, MD6; 1Spine Institute, Louisville, KY, US; 2Louisville, KY, US; 3Washington University Medical Center Department of Orthopedic Surgery, St. Louis, MO, US; 4 Washington University in St. Louis, St. Louis, MO, US; 5Mercy Medical Center, The Spine Center, Towson, MD, US; 6Norton Leatherman Spine Center, Louisville, KY, US BACKGROUND CONTEXT: Surgical site infection (SSI) after posterior instrumented thoracolumbar fusion has been reported to occur in 2.8% to 10% of cases. Increased morbidity and cost make this a potentially devastating event. In an effort to reduce the rate of SSIs, recent studies have reported using intrawound, topical Vancomycin powder. Although cost-effective and promising results have been published, there is concern for development of antibiotic resistance and catastrophic ‘‘superbug’’ infections. PURPOSE: To evaluate the culture profile of SSI after posterior instrumented fusions in patients whom topical Vancomycin powder was used in comparison to controls prior to the use of topical Vancomycin powder. STUDY DESIGN/SETTING: Multicenter retrospective study. PATIENT SAMPLE: 57 patients (15 male, 42 female) with a mean age of 53.2 years were identified with SSIs. OUTCOME MEASURES: Culture results of SSIs with and without the use of topical Vancomycin. METHODS: Patients who had a posterior instrumented spine fusion and subsequently developed SSI from June 2007 to June 2008 and from June 2011 to June 2012 necessitating irrigation and debridement were identified. These two time frames provided cases in which topical Vancomycin was not used and cases after which topical Vancomycin became standard practice. Comparison between these two time intervals provided insight to environmental or institutional infection profiles. Additionally, a direct comparison between patients who received and did not receive topical Vancomycin, regardless of time interval, was done. Patients in which the indication for the index surgery was tumor, trauma, osteomyelitis or discitis were excluded. Patients in whom the index surgery was done elsewhere were also excluded. Standard demographic and surgical data were collected. Culture results and timing of the SSI relative to index surgery were also collected.
RESULTS: Comparison of SSIs pre-Vancomycin (2007-2008) and postVancomycin (2011-2012) identified 31 versus 26 patients, respectively; with no difference in demographic or surgical characteristics. There was no difference in the culture profile between groups (p50.667). The most common organisms were MRSA (8), MSSA (5) and CNS (5) in the preVancomycin group; and MSSA (7) and MRSA (5) in the post-Vancomycin group. When SSIs between cases who had topical Vancomycin and no topical Vancomycin groups were compared, there were 16 versus 41 patients, respectively, with no difference in demographic or surgical characteristics. There was no difference in the culture profile between groups (p50.739). The most common organism was MSSA (6) and MRSA (3) in topical Vancomycin group as well as in the no topical Vancomycin group: MRSA (10), MSSA (6) and CNS (5). CONCLUSIONS: When comparing the culture profile of surgical site infections after posterior instrumented spine fusions, there appears to be no difference comparing a pre-Vancomycin interval versus a post-Vancomycin interval. Additionally, comparing SSIs with or without topical Vancomycin regardless of time interval showed no difference in culture profile. The results of this study suggest that topical Vancomycin powder has not increased the incidence of Vancomycin-resistant, ‘‘super bug’’ infections in the time period studied. Due to the rarity of SSIs, a larger multicenter surveillance study may be needed over a longer time period to determine changes in the culture profile of SSIs after topical Vancomycin use in posterior instrumented spine fusions. FDA DEVICE/DRUG STATUS: Vancomycin powder topical (Not approved for this indication). http://dx.doi.org/10.1016/j.spinee.2013.07.132
85. Incidence and Mortality of Surgical Site Infections After Cervical Spine Surgery Sreeharsha V. Nandyala, BA1, Steven J. Fineberg, MD2, Alejandro Marquez-Lara, MD3, Matthew W. Oglesby, BA2, Miguel A. Pelton, BS2, Alpesh A. Patel, MD, FACS4, Kern Singh, MD3; 1Chicago, IL, US; 2Midwest Orthopaedics at Rush University Medical Center, Chicago, IL, US; 3Rush University Medical Center, Chicago, IL, US; 4 Northwestern Department of Orthopaedics, Chicago, IL, US BACKGROUND CONTEXT: Surgical site infections (SSI) are one of the most common complications after orthopedic procedures. The incidence of this complication in cervical spine surgery has not been reported in large patient populations. PURPOSE: In order to characterize the national burden of SSI, a population-based database was analyzed to identify incidence, mortality, hospitalization days, and costs associated with anterior cervical fusion (ACF), posterior cervical fusion (PCF), and posterior cervical decompression (PCD) procedures. STUDY DESIGN/SETTING: Retrospective national database analysis. PATIENT SAMPLE: Patients that underwent ACF, PCF, or PCD that were recorded in Nationwide Inpatient Sample (NIS) database from 2002-2009. OUTCOME MEASURES: Incidences of SSI, length of stay, in-hospital costs, and mortality. METHODS: Data from the NIS of the Health care Cost and Utilization Project were obtained for each year from 2002-2009. Patients undergoing ACF, PCF and PCD (ie, foraminolaminotomy, laminectomy, laminoplasty) for the diagnosis of cervical radiculopathy and myelopathy were identified. Incidences of surgical site infection were identified and calculated. Comorbidities were calculated using a modified Charlson Comorbidity Index (CCI) score. Mortality associated with these complications was assessed in the 3 surgical subgroups. SPSS v.20 was used for statistical analysis using Independent-Samples T test for discrete variables, c2 test for categorical data, and ANOVA tests for comparing 3 or more means. Binomial logistic regression was used to identify independent predictors of in- hospital mortality and surgical site infection. Due to
Refer to onsite Annual Meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosures and FDA device/drug status at time of abstract submission.