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Results of Vertebral Augmentation Treatment for Patients of Painful Osteoporotic Vertebral Compression Fractures: A Meta-Analysis of Eight Randomized Controlled Trials.

ABSTRACT:

Background

In 2009 two RCTs were publicated to question the efficacy of vertebroplasty comparing with sham treatment (ST) in the New England Journal of Medicine (NEJM), which provoked an academic debate on the efficacy of PVA. The purposes of our study were to compare clinical differences in pain relief, spinal functional outcomes, and overall quality of life between PVA and CT for painful osteoporotic VCFs.

Methods

We searched PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and Web of Knowledge from January 1980 to June 2013 with Medical Subject Headings terms and keywords. Risk of bias in the included studies was assessed in accordance with the Cochrane risk of bias tool. In this Meta-analysis dichotomous and continuous variables were calculated using the risk ratio (RR) and standardized mean difference (SMD), respectively.

Results

Eight studies involving 987 patients met the criteria for inclusion. The VAS SMD was favoring the experimental group significantly (p < 0.001). Subgroup analysis suggested that the patients performed PVA with mean fracture age less than 3 months would got pain relief earlier and more durable than the control group (P <0.05). The SMD of spinal function assessed with RDQ and Oswestry LBP data was in favor of the experimental groups. QOL outcome improvement was demonstrated statistically significant at early, middle and late-term follow-up for PVA than the control group (P <0.05).

Conclusions

In conclusion, this meta-analysis, which evaluated PVA for osteoporotic VCFs, demonstrated significant improvement regarding VAS, spinal function and QOL outcomes. The optimal fracture age was less than 12 weeks.

SUBMITTER: Li L

PROVIDER: S-EPMC4574925 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.

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