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      Prospective Single-Site Experience with Radiofrequency-Targeted Vertebral Augmentation for Osteoporotic Vertebral Compression Fracture

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          Abstract

          Vertebral augmentation procedures are widely used to treat osteoporotic vertebral compression fractures (VCFs). We report our initial experience with radiofrequency-targeted vertebral augmentation (RF-TVA) in 20 patients aged 50 to 90 years with single-level, symptomatic osteoporotic VCF between T10 and L5, back pain severity > 4 on a 0 to 10 scale, Oswestry Disability Index ≥ 21%, 20% to 90% vertebral height loss compared to adjacent vertebral body, and fracture age < 6 months. After treatment, patients were followed through hospital discharge and returned for visits after 1 week, 1 month, and 3 months. Back pain severity improved 66% ( P < 0.001), from 7.9 (95% CI: 7.1 to 8.6) at pretreatment to 2.7 (95% CI: 1.5 to 4.0) at 3 months. Back function improved 46% ( P < 0.001), from 74 (95% CI: 69% to 79%) at pretreatment to 40 (95% CI: 33% to 47%) at 3 months. The percentage of patients regularly consuming pain medication was 70% at pretreatment and only 21% at 3 months. No adverse events related to the device or procedure were reported. RF-TVA reduces back pain severity, improves back function, and reduces pain medication requirements with no observed complications in patients with osteoporotic VCF.

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          Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial.

          Caroline A. H. Klazen, Paul N. M. Lohle, Jolanda De Vries … (2010)
          Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466. Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported. In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. ZonMw; COOK Medical. Copyright © 2010 Elsevier Ltd. All rights reserved.
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            Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995: report from the National Osteoporosis Foundation.

            Alicia Chan, Peter Ray, Scott Melton … (1996)
            Osteoporotic fractures are a significant public health problem, resulting in substantial morbidity and mortality. Previous estimates of the economic burden of osteoporosis, however, have not fully accounted for the costs associated with treatment of nonhip fractures, minority populations, or men. Accordingly, the 1995 total direct medical expenditures for the treatment of osteoporotic fractures were estimated for all persons aged 45 years or older in the United States by age group, sex, race, type of fracture, and site of service (inpatient hospital, nursing home, and outpatient). Osteoporosis attribution probabilities were used to estimate the proportion of health service utilization and expenditures for fractures that resulted from osteoporosis. Health care expenditures attributable to osteoporotic fractures in 1995 were estimated at $13.8 billion, of which $10.3 billion (75.1%) was for the treatment of white women, $2.5 billion (18.4%) for white men, $0.7 billion (5.3%) for nonwhite women, and $0.2 billion (1.3%) for nonwhite men. Although the majority of U.S. health care expenditures for the treatment of osteoporotic fractures were for white women, one-fourth of the total was borne by other population subgroups. By site-of-service, $8.6 billion (62.4%) was spent for inpatient care, $3.9 billion (28.2%) for nursing home care, and $1.3 billion (9.4%) for outpatient services. Importantly, fractures at skeletal sites other than the hip accounted for 36.9% of the total attributed health care expenditures nationally. The contribution of nonhip fractures to the substantial morbidity and expenditures associated with osteoporosis has been underestimated by previous researchers.
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              Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature.

              Jason C Eck, Dean Nachtigall, S Craig Humphreys … (2007)
              Previous investigators have reported on benefits and risks associated with vertebroplasty and kyphoplasty, but there are limited comparison data available. Additionally, much of the data is from retrospective studies and case series. The purpose of this study is to review the literature and perform a meta-analysis of pain relief and risk of complications associated with vertebroplasty versus kyphoplasty. A meta-analysis of the literature on effectiveness of pain control and risk of complications after vertebroplasty versus balloon kyphoplasty. Outcomes measures include visual analog scale and complications. A comprehensive review of the literature was performed. All studies providing information on pain relief and complications were included. Preoperative, postoperative, and change in visual analog scale (VAS) scores were tabulated. Data were analyzed to identify if a significant improvement in the VAS score occurred. Changes in the VAS scores were compared for vertebroplasty and kyphoplasty to determine if there was a significant difference. A total of 1,036 abstracts were identified. Of these, 168 studies met the inclusion criteria. Mean pre- and postoperative VAS scores for vertebroplasty were 8.36 and 2.68, respectively, with a mean change of 5.68 (p<.001). The mean pre- and postoperative VAS scores for kyphoplasty were 8.06 and 3.46, respectively, with a mean change of 4.60 (p<.001). There was statistically greater improvement found with vertebroplasty versus kyphoplasty (p<.001). The risk of new fracture was 17.9% with vertebroplasty versus 14.1% with kyphoplasty (p<.01). The risk of cement leak was 19.7% with vertebroplasty versus 7.0% with kyphoplasty (p<.001). Both vertebroplasty and kyphoplasty provided significant improvement in VAS pain scores. Vertebroplasty had a significantly greater improvement in pain scores but also had statistically greater risk of cement leakage and new fracture.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Osteoporos
                Journal ID (iso-abbrev): J Osteoporos
                Journal ID (publisher-id): JOSTEO
                Title: Journal of Osteoporosis
                Publisher: Hindawi Publishing Corporation
                ISSN (Print): 2090-8059
                ISSN (Electronic): 2042-0064
                Publication date (Print): 2013
                Publication date (Electronic): 20 October 2013
                Volume: 2013
                Electronic Location Identifier: 791397
                Affiliations
                1Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, CA 90048, USA
                2DFINE, Inc., 3047 Orchard Parkway, San Jose, CA 95134, USA
                3Miller Scientific Consulting, Inc., 26 Portobello Road, Arden, NC 28704, USA
                4The Jon Block Group, 2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA
                Author notes
                *Franklin G. Moser: moser@ 123456cshs.org

                Academic Editor: Heikki Kroger

                Article
                DOI: 10.1155/2013/791397
                PMC ID: 3817678
                PubMed ID: 24228187
                SO-VID: 723e7d0e-0fe9-4320-bfc5-620bc2216eac
                Copyright © Copyright © 2013 Franklin G. Moser et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 25 April 2013
                Date revision received : 5 September 2013
                Date accepted : 15 September 2013
                Categories
                Subject: Clinical Study

                ScienceOpen disciplines: Orthopedics
                Data availability:
                ScienceOpen disciplines: Orthopedics

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