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Daniel Cher,1 David Polly,2 Sigurd Berven31SI-BONE, Inc., San Jose, CA, USA; 2Department of Orthopedic Surgery, University of Minnesota, Minneapolis, MN, USA; 3Department of Orthopedic Surgery, University of California San Francisco, San Francisco, CA, USAObjectives: The sacroiliac joint (SIJ) is an important and significant cause of low back pain. We sought to quantify the burden of disease attributable to the SIJ.Methods: The authors compared EuroQol 5D (EQ-5D) and Short Form (SF)-36-based health state utility values derived from the preoperative evaluation of patients with chronic SIJ pain participating in two prospective clinical trials of minimally invasive SIJ fusion versus patients participating in a nationally representative USA cross-sectional survey (National Health Measurement Study [NHMS]). Comparative analyses controlled for age, sex, and oversampling in NHMS. A utility percentile for each SIJ subject was calculated using NHMS as a reference cohort. Finally, SIJ health state utilities were compared with utilities for common medical conditions that were published in a national utility registry.Results: SIJ patients (number [n]=198) had mean SF-6D and EQ-5D utility scores of 0.51 and 0.44, respectively. Values were significantly depressed (0.28 points for the SF-6D utility score and 0.43 points for EQ-5D; both P

Carl Lauryssen,1 Sigurd Berven,2 Ronnie Mimran,3 Christopher Summa,4 Michael Sheinberg,5 Larry E Miller,6,7 Jon E Block71Tower Orthopedics, Beverly Hills, CA, USA; 2Department of Orthopedics, University of California, San Francisco, San Francisco, CA, USA; 3Pacific Brain and Spine, Castro Valley, CA, USA; 4The Spine Clinic of Monterey Bay, Soquel, CA, USA; 5Danville, CA, USA; 6Miller Scientific Consulting Inc, Arden, NC, USA; 7The Jon Block Group, San Francisco, CA, USABackground: Laminectomy/laminotomy and foraminotomy are well established surgical techniques for treatment of symptomatic lumbar spinal stenosis. However, these procedures have significant limitations, including limited access to lateral and foraminal compression and postoperative instability. The purpose of this cadaver study was to compare bone, ligament, and soft tissue morphology following lumbar decompression using a minimally invasive MicroBlade Shaver® instrument versus hemilaminotomy with foraminotomy (HL).Methods: The iO-Flex® system utilizes a flexible over-the-wire MicroBlade Shaver instrument designed for facet-sparing, minimally invasive “inside-out” decompression of the lumbar spine. Unilateral decompression was performed at 36 levels in nine human cadaver specimens, six with age-appropriate degenerative changes and three with radiographically confirmed multilevel stenosis. The iO-Flex system was utilized on alternating sides from L2/3 to L5/S1, and HL was performed on the opposite side at each level by the same investigator. Spinal canal, facet joint, lateral recess, and foraminal morphology were assessed using computed tomography.Results: Similar increases in soft tissue canal area and decreases in ligamentum flavum area were noted in nondiseased specimens, although HL required removal of 83% more laminar area (P < 0.01) and 95% more bone resection, including the pars interarticularis and facet joints (P < 0.001), compared with the iO-Flex system. Similar increases in lateral recess diameter were noted in nondiseased specimens using each procedure. In stenotic specimens, the increase in lateral recess diameter was significantly (P = 0.02) greater following use of the iO-Flex system (43%) versus HL (7%). The iO-Flex system resulted in greater facet joint preservation in nondiseased and stenotic specimens. In stenotic specimens, the iO-Flex system resulted in a significantly greater increase in foraminal width compared with HL (24% versus 4%, P = 0.01), with facet joint preservation.Conclusion: The iO-Flex system resulted in significantly better decompression of the lateral recess and foraminal areas compared with HL, while preserving posterior spinal elements, including the facet joint.Keywords: decompression, laminectomy, lumbar, minimally invasive, stenosis, MicroBlade Shaver, iO-Flex system

We reviewed all peer-reviewed papers analysing the cost-effectiveness of vertebroplasty and balloon kyphoplasty for osteoporotic vertebral compression fractures. In general, the procedures appear to be cost effective but are very dependent upon model input details. Better data, rather than new models, are needed to answer outstanding questions. Vertebral augmentation procedures (VAPs), including vertebroplasty (VP) and balloon kyphoplasty (BKP), seek to stabilise fractured vertebral bodies and reduce pain. The aim of this paper is to review current literature on the cost-effectiveness of VAPs as well as to discuss the challenges for economic evaluation in this research area. A systematic literature search was conducted to identify existing published studies on the cost-effectiveness of VAPs in patients with osteoporosis. Only peer-reviewed published articles that fulfilled the criteria of being regarded as full economic evaluations including both morbidity and mortality in the outcome measure in the form of quality-adjusted life years (QALYs) were included. The search identified 949 studies, of which four (0.4 %) were identified as relevant with one study added later. The reviewed studies differed widely in terms of study design, modelling framework and data used, yielding different results and conclusions regarding the cost-effectiveness of VAPs. Three out of five studies indicated in the base case results that VAPs were cost effective compared to non-surgical management (NSM). The five main factors that drove the variations in the cost-effectiveness between the studies were time horizon, quality of life effect of treatment, offset time of the treatment effect, reduced number of bed days associated with VAPs and mortality benefit with treatment. The cost-effectiveness of VAPs is uncertain. In answering the remaining questions, new cost-effectiveness analysis will yield limited benefit. Rather, studies that can reduce the uncertainty in the underlying data, especially regarding the long-term clinical outcomes of VAPs, should be conducted. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: Multicenter study. OBJECTIVE: The purpose of this study is to prospectively analyze responsiveness of the SRS-22 to change at 1 and 2 years following primary surgery. SUMMARY OF BACKGROUND DATA: A number of efforts have been directed at validation of the SRS-22 instrument in the setting of adolescent and adult spinal deformity. However, few have extensively analyzed the ability of the instrument to detect change (brought on by surgical treatment) in adult scoliosis patients. METHODS: A multicenter prospective series of consecutive adult scoliosis patients (all primary/no revisions) were administered SRS-22, Oswestry Disability Index (ODI)and Short Form-12 (SF-12) questionnaires preoperation and 1 and 2 years postoperation. Fifty-six patients had preoperative, 1-year postoperative, and 2-year postoperative data. RESULTS: The greatest changes from preoperation to 2-year postoperation were the SRS self-image domain followed by SRS total, SRS pain, and ODI scores. SRS pain and function scores significantly (P < 0.05) improved from 1-year to 2-year postoperation. There were not substantial differences in the outcome measures according to age or curve type. All outcome measures except SF-12 mental health showed statistically significant (P < 0.05) improvement from baseline to 2-year follow-up. CONCLUSION: Based on these 3 outcome tools, the greatest responsiveness to change was demonstrated by the SRS self-image domain followed by SRS total, then SRS pain, then ODI. This suggests that the SRS tool is more responsive than ODI, which is more responsive than SF-12 to change brought on by primary surgical treatment of adult scoliosis patients. Surgical treatment in adult scoliosis significantly improved pain, self-image, and function based on the health-related quality of life measures used in this study. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: The enrollment data were retrospectively reviewed for 1,061 patients entered into a prospective multicenter study of adult spinal deformity between January 2002 and June 2004. OBJECTIVE: The purpose of this study is to quantify and analyze the use of nonsurgical resources in patients with adult spinal deformity. SUMMARY OF BACKGROUND DATA: Limited data exist regarding the utilization of nonsurgical treatment methods for adult spinal deformity. METHODS: Demographic data, surgical history, symptom assessment, and nonsurgical treatment regimen were reviewed. Health status measures were the SF-12, SRS-29, and ODI. Nonsurgical patients were divided into low- and high-symptom subgroups based on age adjusted ODI score. Resource utilization was analyzed based on both patient and physician questionnaire responses. RESULTS: High- and low-symptom nonsurgical subgroups differed significantly on all reported health status measures (P < 0.0001). High-symptom patients used greater resources in terms of narcotics, epidural blocks, and physical agent methods (P < 0.001), analgesics (P < 0.01), pain management referral and bed rest (P < 0.02), strength training, nerve root blocks, and stabilization exercises (P < 0.05). CONCLUSIONS: The results of this study demonstrate that, within the population of adult deformity patients, distinct high- and low-symptom groups exist and can be clearly identified. While high-symptom patients used significantly greater resources, most low-symptom patients used nonsurgical resources as well. [ABSTRACT FROM AUTHOR]

Study Design: Observational study of patients with scoliosis and matched controls. Objectives: To determine the validity and reliability of the modified Scoliosis Research Society Outcomes Instrument (SRS-22) for use in the assessment of deformity in adults. To demonstrate the discriminate validity of the SRS-22 in differentiating between affected and unaffected adults. Summary Of Background Data: Spinal deformity has an important impact on the general health status of adults. The magnitude of this impact has been difficult to measure and reported variably in the literature. The development of disease-specific outcomes tools permits improved sensitivity and specificity in measuring the patient's self-assessment of health status. An instrument for measuring disease-specific health status in adults with scoliosis has not been validated. Materials and Methods: Observational study comparing the health status of adults affected by scoliosis and unaffected controls, matched for age, gender, and socioeconomic status. Pearson correlation analysis was used to determine the relationship of each domain within the SRS-22 and SF-36 with radiographic parameters including sagittal balance, coronal balance, and major curve correction. Discriminate validity of the modified SRS instrument was determined by a comparison of means between affected and unaffected cohorts. The validation of the SRS-22 was determined by criterion validity, using correlation analysis with comparable domains of the SF-36. The reliability of the SRS-22 was demonstrated using test-retest parity and Cronbach's alpha test for internal consistency. Results: One hundred eighty adults were included in the study, 146 with scoliosis and 34 without. Adults with scoliosis scored significantly lower than unaffected controls on every domain of the SRS-22 and the SF-36. The floor and ceiling effect of the SRS-22 were less than observed in the SF-36 instrument. Pearson correlation analysis demonstrated no significant correlation between any radiographic process measure and any specific domain within the SRS-22 or the SF-36 (r < 0.25). Comparison of similar domains in the SRS-22 and the SF-36 demonstrates high correlation between the instruments. Test-retest analysis similarly demonstrates a high degree of reproducibility in each domain (r = 0.83-0.94). Cronbach's alpha test of internal consistency within each domain demonstrates intercorrelation values greater than 0.75 within each domain of the SRS-22. Conclusions: Adult scoliosis has a significant and measurable impact on affected patients compared with controls. There is a poor correlation between radiographic parameters of outcome and patient self-assessment of health status. The SRS-22 is a reliable instrument in adults as demonstrated by a high degree of internal consistency and reproducibility. The SRS-22 is a valid instrument for use in adult deformity as demonstrated by the criterion validity assessment with the SF-36. The study supports the use of the SRS-22 in the adult spinal deformity population. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: Systematic literature review. OBJECTIVES: To examine the available literature on health related quality of life (HRQOL) assessment in metastatic disease of the spine and identify the optimal functional outcome scales to be used in developing a disease-specific tool. SUMMARY OF BACKGROUND DATA: There is a lack of consensus in the use of HRQOL measures in patients with metastatic spine disease. METHODS: A systematic review was conducted using MEDLINE, EMBASE, the Science Citation Index (ISI), the Cumulative Index to Nursing and Allied Health Literature, the PsycINFO, the Allied and Complementary Medicine (AMED), Cochrane Reviews and Global Health databases for clinical studies addressing metastatic spine disease from 1966 through 2008. The validity of outcome tools was established by linkage analysis with the International Classification of Functioning Disability and Health (ICF). RESULTS: One hundred forty-one clinical studies met inclusion criteria including 10,347 patients. Only 5 moderate grade and 1 high grade study were identified. Thirty- four studies used a patient self-assessment instrument to assess health status. None of the instruments were validated for metastatic spine patients. The most commonly used Pi-by-no tools were SF-36, SIP 5, and the ADL. None of the studies defined health related quality of life (HRQOL) or justified the choice of instrument. The most commonly used cancer-specific tools were ECOG, EORTC QCQ-C30, and EUROQOL 5D. Based on frequency of citation and on correlation with the International Classification of Functioning Disability and Health, the ECOG and SF36 were judged as most valid and reliable. CONCLUSION: A systematic review of the available evidence suggests that valid and reliable health related quality of life measures exist for the assessment of oncology patients; however, a disease-specific tool for metastatic spine disease awaits development. Until such time as a disease-specific tool is available, we recommend that the ECOG and SF-36 be considered for use in studies addressing the outcome assessment of patients with metastatic spine disease. [ABSTRACT FROM AUTHOR]