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Vertebral augmentation effective in osteoporotic vertebral compression fracture at 1 year
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December 2015
Vertebral augmentation effective in osteoporotic vertebral compression fracture at 1 year
Study Type:Meta analysis
OE Level Evidence:1
Journal Level of Evidence:N/A
Results of Vertebral Augmentation Treatment for Patients of Painful Osteoporotic Vertebral Compression Fractures: A Meta-Analysis of Eight Randomized Controlled Trials
PLoS One. 2015 Sep 17;10(9):e0138126Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
8 randomized controlled trials were included in this meta-analysis for the purpose of comparing pain relief, spinal function, and quality of life in percutaneous vertebral augmentation (PVA) in comparison to conventional treatment for painful osteoporotic vertebral compression fractures. Pain scores, spinal functional outcomes, and quality of life were all significantly in favor of the percutaneous vertebral augmentation groups up to 1 year post-operatively in comparison to conventional treatment. Subgroup analysis indicated that percutaneous vertebral augmentation in fractures less than 3 months old would cause greater pain relief.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
Beijing Municipal Science and Technology Commission
Conflicts:
None disclosed
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Introduction
4/4
Accessing Data
4/4
Analysing Data
4/4
Results
2/4
Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
The use and efficacy of percutaneous vertebral augmentation (PVA), such as vertebroplasty and balloon kyphoplasty, has been a topic of debate in the treatment of painful osteoporotic vertebral compression fractures. A number of reports have shown conflicting results ultimately altering the treatment recommendations for these fractures. Recent randomized controlled trials (RCTs) had been published comparing vertebroplasty and balloon kyphoplasty to conventional treatment in painful osteoporotic VCFs and thus the present study was prudent to provide an updated assessment of available high-quality literature.
What was the principal research question?
How do the clinical differences in pain relief, spinal functional outcomes, and overall quality of life compare between percutaneous vertebral augmentation and conventional treatment for the management of painful osteoporotic vertebral compression fractures?
Study Characteristics
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Data Source:
A computerized database search was conducted using PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Web of Knowledge, Chinese Biomedical Literature Database, and Wanfang Data from January 1980 to June 2013, with no language restrictions. Reference lists were manually searched in order to retrieve any articles missed by the electronic search.
Index Terms:
Search strategy for Pubmed: "(((((spinal compression fracture) OR vertebral compression fracture)) OR "Fractures, Compression"[Mesh])) AND (((((Vertebroplasty) OR kyphoplasty) OR vertebral augmentation)) OR (("Vertebroplasty"[Mesh]) OR "Kyphoplasty"[Mesh]))) AND (((random) OR "Randomized Controlled Trials as Topic"[Mesh]) OR randomized controlled trial [Publication Type])".
Study Selection:
Inclusion criteria were published randomized controlled trials (RCTs) or quasi-RCTs that compared either vertebroplasty or balloon kyphoplasty to conventional treatment, sham treatment or other interventions for osteoporotic vertebral compression fractures. Patients must have been aged greater than 50 years with acute or chronic osteoporotic VCF that caused pain and functional limitations. Two independent authors reviewed articles for adherence to inclusion criteria, disagreements were resolved via consensus or via a third author. 8 RCT's including 987 patients (759 male, 229 female) were included, 5 compared vertebroplasty with conventional treatment, 2 compared vertebroplasty with sham treatment and 1 RCT compared balloon kyphoplasty with conventional treatment.
Data Extraction:
Two independent reviewers extracted data using an extraction form. Data was checked by a third reviewer. Outcomes included pain relief via visual analogue scale (VAS), spinal functional outcomes via the Roland-Morris Disability Questionnaire (RDQ) and the Oswestry low back pain score, overall quality of life outcomes via the European Quality of Life-5 Dimensions (EQ-5D) and the Quality of life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO), as well as new events of VCF and new adjacent VCF.
Data Synthesis:
Analyses were conducted using STATA 12.0 software. Continuous variables were expressed via mean difference (MD) from baseline to endpoint and the experimental group and control group were compared via standardized mean difference (SMD) with corresponding 95% confidence intervals (CI's). Dichotomous outcomes were represented with risk ratio (RR) and 95% CIs. The studies were assumed to be heterogeneous and a random effects model was used. The Galbraith plot was used to assess heterogeneity, and if heterogeneity existed a sensitivity analysis was performed to detect the source of heterogeneity, and the fixed effects model was then used.
What were the important findings?
- VAS pain in the early-term follow-up (1 week to 1 month), middle-term follow-up (2-3 months) and the late-term follow-up (1 year) all significantly favored the experimental group (Early: 7 studies; SMD 0.30 [95% CI 0.09, 0.51]; p=0.005; I2=77.9% | Middle: 7 studies; SMD 0.28 [95% CI 0.14, 0.42]; p=0.000; I2=51.3% | Late: 5 studies; SMD 0.26 [95% CI 0.12, 0.41]; p=0.000; I2=41.5%). Sensitivity analysis did not alter these results.
- Subgroup analysis of VAS scores indicated that the efficacy of vertebroplasty and balloon kyphoplasty on pain relief was greater than conventional treatment at all timepoints and that the difference was significant with the exception of vertebroplasty in the early follow-up (p=0.06)
- No difference in pain was noted between vertebroplasty and sham treatment in the early and middle term follow-up
- Subgroup analysis of VAS score suggested that patients with PVA performed with a fracture age of less than 3 months would get earlier pain relief than control group, and that MRI is beneficial as inclusion criteria at all time points (p<0.05)
- Spinal functional outcomes in the early-term, middle-term, and late-term follow up all significantly favored the experimental group (Early: 6 studies; SMD 0.32 [95% CI 0.10, 0.54]; p=0.004; I2=75.7% | Middle: 5 studies; SMD 0.24 [95% CI 0.05, 0.42]; p=0.011; I2=65.2% | Late: 3 studies; SMD 0.26 [0.14, 0.38]; p=0.000; I2=0%). Sensitivity analysis did not change the significance of these results (p<0.001).
- Quality of life outcomes in the early-term, middle-term, and late-term follow up all significantly favored the experimental group (Early: 6 studies; SMD 0.23 [95% CI 0.14, 0.33]; p=0.000; I2=0% | Middle: 4 studies; SMD 0.23 [95% CI 0.05, 0.41]; p=0.012; I2=60.3% | Late: 3 studies; SMD 0.23 [95% CI 0.11, 0.34]; p=0.000; I2=0.6%), sensitivity analysis did not alter these results.
- There was no significant difference in the risk of new VCFs (7 studies) or adjacent VCFs (5 studies) between 2 weeks and 2 years between the experimental and control groups (RR 1.09 [95% CI 0.61, 1.97]; p=0.77 and 1.80 [95% CI 0.61, 5.30]; p=0.28, respectively)
What should I remember most?
Pain scores, spinal functional outcomes, and quality of life were significantly in favor of the percutaneous vertebral augmentation groups in the early, middle, and late term follow-up (up to 1 year) in comparison to control treatments. Subgroup analysis indicated that patients receiving percutaneous vertebral augmentation with a fracture age less than 3 months would get earlier pain relief than the control group.
How will this affect the care of my patients?
The results of this study indicate that percutaneous vertebral augmentation for the treatment of osteoporotic vertebral compression fractures may provide improvements in pain, spinal function, and quality of life in comparison to control treatments up to 1 year post-operatively. Further high quality RCTs are needed to add to the current body of literature and examine if differences clinically meaningful.
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