European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Multicenter Study
Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation.
In this open prospective trial, 53 patients with acute pain from osteoporotic vertebral fracture related to osteoporosis or malignancy underwent vertebral augmentation with a new bisphenol-a-glycidyl dimethacrylate (bis-GMA) resin (Cortoss, Orthovita, Malvern, Pa, USA). Treatment consisted of up to 8 ml of Cortoss injected into a given vertebra. The procedure encompassed single and multiple injections (including the contralateral hemivertebra, to a maximum of 3 vertebral levels). ⋯ A total of 20 adverse events were deemed to be device-related. The most frequent clinically significant adverse events attributed to Cortoss were leakage of Cortoss from within the vertebral body at placement (12%), back pain (7%), and unspecified pain (7%). These results indicate that vertebral augmentation with Cortoss rapidly reduces pain, decreases disability, and improves physical functioning in patients with painful vertebral compression fractures.
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Adult scoliosis is defined as a spinal deformity in a skeletally mature patient with a Cobb angle of more than 10 degrees in the coronal plain. Adult scoliosis can be separated into four major groups: Type 1: Primary degenerative scoliosis, mostly on the basis of a disc and/or facet joint arthritis, affecting those structures asymmetrically with predominantly back pain symptoms, often accompanied either by signs of spinal stenosis (central as well as lateral stenosis) or without. These curves are often classified as "de novo" scoliosis. ⋯ Although this surgery is demanding, the morbidity cannot be considered significantly higher than in other established orthopaedic procedures, like hip replacement, in the same age group of patients. Overall, a satisfactory outcome can be expected in well-differentiated indications and properly tailored surgical procedures, although until today prospective, controlled studies with outcome measures and pre- and post-operative patient's health status are lacking. As patients, who present themselves with significant clinical problems in the context of adult scoliosis, get older, minimal invasive procedures to address exactly the most relevant clinical problem may become more and more important, basically ignoring the overall deformity and degeneration of the spine.
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The Spine Tango registry is now accessible via the SSE webpage under www.eurospine.org-Spine Tango. Links to the Swiss/International, German and Austrian modules are provided as well as information about the philosophy, methodology and content. Following the links, the users are taken to the respective national modules for registration or log-in and data entry. ⋯ The physician administered forms for surgery, staged surgery and follow-up can be downloaded as PDFs. The officially recommended Spine Tango patient forms are also available. All forms were implemented in an online version and as scannable optical mark reader forms which can be ordered from the corresponding author.
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Comparative Study
Health-related quality of life assessment by the EuroQol-5D can provide cost-utility data in the field of low-back surgery.
There is limited data on the cost-utility of low-back surgical procedures. The EuroQol-5D (EQ-5D) is a generic health-related quality of life (HRQL) instrument, which was designed for cost-utility analyses and for comparisons of therapeutic effects across different diseases. Disease-specific (HRQL) instruments cannot be used for such purposes. ⋯ The reliability of the EQ-5D was solid. Our results indicate that the EQ-5D is useful for estimating health state values and for monitoring outcome of patients undergoing low-back surgery. Hence, this instrument would provide valid data for cost-utility analyses.
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The present study examined the psychometric characteristics of a "core-set" of six individual questions (on pain, function, symptom-specific well-being, work disability, social disability and satisfaction) for use in low back pain (LBP) outcome assessment. A questionnaire booklet was administered to 277 German-speaking LBP patients with a range of common diagnoses, before and 6 months after surgical (N=187) or conservative (N=90) treatment. The core-set items were embedded in the booklet alongside validated 'reference' questionnaires: Likert scales for back/leg pain; Roland and Morris disability scale; WHO Quality of Life scale; Psychological General Well-Being Index. ⋯ The composite index score had an effect size (sensitivity to change) of 0.95, which was larger than most of the reference questionnaires (0.47-1.01); for individual core items, the effect sizes were 0.52-0.87. The core items provide a simple, practical, reliable, valid and sensitive assessment of outcome in LBP patients. We recommend the widespread and consistent use of the core-set items and their composite score index to promote standardisation of outcome measurements in clinical trials, multicentre studies, routine quality management and surgical registry systems.