Project description:OBJECTIVE:To assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body. DESIGN:Randomised, double blind, sham controlled clinical trial. SETTING:Four community hospitals in the Netherlands, 2011-15. PARTICIPANTS:180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89). INTERVENTIONS:Participants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group. MAIN OUTCOME MEASURES:Main outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months' follow-up. RESULTS:The mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval -0.53 to 0.94) at baseline, -0.43 (-1.17 to 0.31) at one day, -0.11 (-0.85 to 0.63) at one week, 0.41 (-0.33 to 1.15) at one month, 0.21 (-0.54 to 0.96) at three months, 0.39 (-0.37 to 1.15) at six months, and 0.45 (-0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months' follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction. CONCLUSIONS:Percutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months' follow-up among patients with acute osteoporotic vertebral compression fractures. TRIAL REGISTRATION:ClinicalTrials.gov NCT01200277.

Project description:BackgroundOsteoporotic vertebral compression fracture, always accompanied with pain and height loss of vertebral body, has a significant negative impact on life quality of patients. Vertebroplasty or kyphoplasty is minimal invasive techniques to reconstruct the vertebral height and prevent further collapse of the fractured vertebrae by injecting polymethylmethacrylate into vertebral body. However, recompression of polymethylmethacrylate augmented vertebrae with significant vertebral height loss and aggressive local kyphotic was observed frequently after VP or KP. The purpose of this study was to investigate the effect of polymethylmethacrylate distribution on recompression of the vertebral body after vertebroplasty or kyphoplasty surgery for osteoporotic vertebral compression fracture.MethodsA total of 281 patients who were diagnosed with vertebral compression fracture (T5-L5) from June 2014 to June 2016 and underwent vertebroplasty or kyphoplasty by polymethylmethacrylate were retrospectively analyzed. The X-ray films at 1 day and 12 months after surgery were compared to evaluate the recompression of operated vertebral body. Patients were divided into those without recompression (non-recompression group) and those with recompression (recompression group). Polymethylmethacrylate distribution pattern, including location and relationship to endplates, was compared between the two groups by lateral X-ray film. Multivariate logistic regression analysis was performed to assess the potential risk factors associated with polymethylmethacrylate distribution for recompression.ResultsOne hundred and six (37.7%) patients experienced recompression after surgery during the follow-up period. The polymethylmethacrylate distributed in the middle of vertebral body showed significant differences between two groups. In non-recompression group, the polymethylmethacrylate in the middle portion of vertebral body were closer to endplates than that in the recompression group (upper: t = 31.41, p<0.001; lower: t = 12.19, p<0.001). The higher percentage of the height of polymethylmethacrylate in the middle portion of vertebral body indicates the lower risk of recompression (odds ratio [OR]<0.01, p<0.001). The recompression group and non-recompression group showed significant difference in "contacted" polymethylmethacrylate distribution pattern (polymethylmethacrylate contacted to the both upper/lower endplates) (χ2 = 66.23, p<0.001). The vertebra with a "contacted" polymethylmethacrylate distribution pattern has lower risk of recompression (OR = 0.09, p<0.001).ConclusionsEither more polymethylmethacrylate in the middle portion of vertebral body or "contacted" polymethylmethacrylate distribution pattern had a significantly less incidence of recompression. The findings indicated that the control of polymethylmethacrylate distribution during surgery may reduce the risks of recompression after vertebroplasty or kyphoplasty.

Project description:BackgroundCorticosteroid treatment is considered the 'gold standard' for Duchenne muscular dystrophy (DMD); however, it is also known to induce osteoporosis and thus increase the risk of vertebral fragility fractures. Good practice in the care of those with DMD requires prevention of these adverse effects. Treatments to increase bone mineral density include bisphosphonates and vitamin D and calcium supplements, and in adolescents with pubertal delay, testosterone. Bone health management is an important part of lifelong care for patients with DMD.ObjectivesTo assess the effects of interventions to prevent or treat osteoporosis in children and adults with DMD taking long-term corticosteroids; to assess the effects of these interventions on the frequency of vertebral fragility fractures and long-bone fractures, and on quality of life; and to assess adverse events.Search methodsOn 12 September 2016, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL Plus to identify potentially eligible trials. We also searched the Web of Science ISI Proceedings (2001 to September 2016) and three clinical trials registries to identify unpublished studies and ongoing trials. We contacted correspondence authors of the included studies in the review to obtain information on unpublished studies or work in progress.Selection criteriaWe considered for inclusion in the review randomised controlled trials (RCTs) and quasi-RCTs involving any bone health intervention for corticosteroid-induced osteoporosis and fragility fractures in children, adolescents, and adults with a confirmed diagnosis of DMD. The interventions might have included oral and intravenous bisphosphonates, vitamin D supplements, calcium supplements, dietary calcium, testosterone, and weight-bearing activity.Data collection and analysisTwo review authors independently assessed reports and selected potential studies for inclusion, following standard Cochrane methodology. We contacted study authors to obtain further information for clarification on published work, unpublished studies, and work in progress.Main resultsWe identified 18 potential studies, of which two, currently reported only as abstracts, met the inclusion criteria for this review. Too little information was available for us to present full results or adequately assess risk of bias. The participants were children aged five to 15 years with DMD, ambulant and non-ambulant. The interventions were risedronate versus no treatment in one trial (13 participants) and whole-body vibration versus a placebo device in the second (21 participants). Both studies reported improved bone mineral density with the active treatments, with no improvement in the control groups, but the abstracts did not compare treatment and control conditions. All children tolerated whole-body vibration treatment. No study provided information on adverse events. Two studies are ongoing: one investigating whole-body vibration, the other investigating zoledronic acid.Authors' conclusionsWe know of no high-quality evidence from RCTs to guide use of treatments to prevent or treat corticosteroid-induced osteoporosis and reduce the risk of fragility fractures in children and adults with DMD; only limited results from two trials reported in abstracts were available. We await formal trial reports. Findings from two ongoing relevant studies and two trials, for which only abstracts are available, will be important in future updates of this review.

Project description:BackgroundOsteoporotic vertebral compression fractures (OVCF) is a common and often debilitating complication of osteoporosis, leading to significant morbidity and increased mortality. Percutaneous vertebroplasty (PVP) and Percutaneous kyphoplasty (PKP) are recommendable surgical treatments for OVCF.ObjectiveTo evaluate PVP/PKP utilisation and their related direct medical costs for OVCF treatment in China from the payer perspective.MethodsA population-based medical claims database of a metropolitan city in China was analysed from the payer perspective, which included all inpatient claims from 01/01/2015 to 31/12/2017. All vertebral fractures patients that met the eligibility criteria (aged ≥50 years old, having vertebral fracture diagnosis, without unrelated diseases diagnoses such as tumour and scoliosis, received PVP/PKP) were deemed as OVCF patients. Baseline characteristics, surgery rate, length of stay in hospital, time to re-surgery, and costs (including costs per hospitalisation and annual costs) were described. Survival analysis function was used to estimate the re-surgery rate.ResultsOf the 50,686 patients with OVCF identified, 14,527 (28.66%) received a total number of 15,599 records of PVP/PKP surgeries from 2015 to 2017. Mean age was 75 at the first surgery captured in the database analysis period; females accounted for 79.54% of all cases. The median length of surgery stay was 9 days. Cumulative re-surgery rates were 1.22% in 30 days, 2.58% in 90 days, 3.61% in 183 days, 5.42% in 1 year, and 7.95% in 2 years. There was no significant difference in re-surgery rate between PVP and PKP (p = 0.3897). The median time to the re-surgery was 139 days. Mean costs per PVP/PKP-related hospitalisation were 35,906 CNY/5122 USD (34,195 CNY/4878USD for PVP, 44,414 CNY/6336 USD for PKP, p < 0.01). The overall costs of hospitalisation averaged 186.61 million CNY (26.62 million USD) per year in this metropolitan city.ConclusionFrom 2015 to 2017, nearly one-third of OVCF inpatients received PVP/PKP and the re-surgery rate was 7.95%. PVP/PKP procedures for OVCF place a high economic burden for both the healthcare system and patients. Early detection and treatment of patients with osteoporosis are critical in China.

Dataset Information

Vertebroplasty for Treatment of Steroid-Induced Osteoporotic Vertebral Compression Fractures in an Adolescent With Duchenne Muscular Dystrophy.

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