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Meta-Analysis
. 2018 Apr 4;4(4):CD006349.
doi: 10.1002/14651858.CD006349.pub3.

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

Rachelle Buchbinder  1 , Renea V Johnston, Kobi J Rischin, Joanne Homik, C Allyson Jones, Kamran Golmohammadi, David F Kallmes
Affiliations
Meta-Analysis

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

Rachelle Buchbinder et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice.

Objectives: To update the available evidence of the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures.

Search methods: We updated the search of CENTRAL, MEDLINE and Embase and trial registries to 15 November 2017.

Selection criteria: We included randomised and quasi-randomised controlled trials (RCTs) of adults with painful osteoporotic vertebral fractures, comparing vertebroplasty with placebo (sham), usual care, or another intervention. As it is least prone to bias, vertebroplasty compared with placebo was the primary comparison. Major outcomes were mean overall pain, disability, disease-specific and overall health-related quality of life, patient-reported treatment success, new symptomatic vertebral fractures and number of other serious adverse events.

Data collection and analysis: We used standard methodologic procedures expected by Cochrane.

Main results: Twenty-one trials were included: five compared vertebroplasty with placebo (541 randomised participants), eight with usual care (1136 randomised participants), seven with kyphoplasty (968 randomised participants) and one compared vertebroplasty with facet joint glucocorticoid injection (217 randomised participants). Trial size varied from 46 to 404 participants, most participants were female, mean age ranged between 62.6 and 81 years, and mean symptom duration varied from a week to more than six months.Three placebo-controlled trials were at low risk of bias and two were possibly susceptible to performance and detection bias. Other trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding.Compared with placebo, high- to moderate-quality evidence from five trials (one with incomplete data reported) indicates that vertebroplasty provides no clinically important benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success at one month. Evidence for quality of life and treatment success was downgraded due to possible imprecision. Evidence was not downgraded for potential publication bias as only one placebo-controlled trial remains unreported. Mean pain (on a scale zero to 10, higher scores indicate more pain) was five points with placebo and 0.6 points better (0.2 better to 1 better) with vertebroplasty, an absolute pain reduction of 6% (2% better to 10% better, minimal clinical important difference is 15%) and relative reduction of 9% (3% better to14% better) (five trials, 535 participants). Mean disability measured by the Roland-Morris Disability Questionnaire (scale range zero to 23, higher scores indicate worse disability) was 14.2 points in the placebo group and 1.7 points better (0.3 better to 3.1 better) in the vertebroplasty group, absolute improvement 7% (1% to 14% better), relative improvement 10% better (3% to 18% better) (three trials, 296 participants).Disease-specific quality of life measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (scale zero to 100, higher scores indicating worse quality of life) was 62 points in the placebo group and 2.75 points (3.53 worse to 9.02 better) in the vertebroplasty group, absolute change: 3% better (4% worse to 9% better), relative change: 5% better (6% worse to 15% better (two trials, 175 participants). Overall quality of life (European Quality of Life (EQ5D), zero = death to 1 = perfect health, higher scores indicate greater quality of life) was 0.38 points in the placebo group and 0.05 points better (0.01 better to 0.09 better) in the vertebroplasty group, absolute improvement: 5% (1% to 9% better), relative improvement: 18% (4% to 32% better) (three trials, 285 participants). In one trial (78 participants), 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; 95% CI 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute difference: 9% more reported success (11% fewer to 29% more); relative change: 40% more reported success (33% fewer to 195% more).Moderate-quality evidence (low number of events) from seven trials (four placebo, three usual care, 1020 participants), up to 24 months follow-up, indicates we are uncertain whether vertebroplasty increases the risk of new symptomatic vertebral fractures (70/509 (or 130 per 1000; range 60 to 247) observed in the vertebroplasty group compared with 59/511 (120 per 1000) in the control group; RR 1.08 (95% CI 0.62 to 1.87)).Similarly, moderate-quality evidence (low number of events) from five trials (three placebo, two usual care, 821 participants), indicates uncertainty around the risk of other serious adverse events (18/408 or 76 per 1000, range 6 to 156) in the vertebroplasty group compared with 26/413 (or 106 per 1000) in the control group; RR 0.64 (95% CI 0.36 to 1.12). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.Our subgroup analyses indicate that the effects did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Including data from the eight trials that compared vertebroplasty with usual care in a sensitivity analyses altered the primary results, with all combined analyses displaying considerable heterogeneity.

Authors' conclusions: Based upon high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty for treating acute or subacute osteoporotic vertebral fractures in routine practice. We found no demonstrable clinically important benefits compared with placebo (sham procedure) and subgroup analyses indicated that the results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks.Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the high- to moderate-quality evidence that shows no important benefit of vertebroplasty and its potential for harm.

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Conflict of interest statement

R Buchbinder was a principal investigator of Buchbinder 2009. D Kallmes was a principal investigator of Kallmes 2009 and Evans 2015. D Kallmes participated in IDE trial for Benvenue Medical spinal augmentation device. He is a stockholder, Marblehead Medical, LLC, Development of spine augmentation devices. He holds a spinal fusion patent license, unrelated to spinal augmentation/vertebroplasty. For all other authors there were no known declarations of interest.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figure 3
Figure 3
'Risk of bias summary': review authors' judgements about the risk of bias of the available evidence presented as percentages across all included studies.
Analysis 1.1
Analysis 1.1
Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 1 Pain (0 to 10 point scale).
Analysis 1.2
Analysis 1.2
Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 2 Proportion of participants with pain improved by a clinically relevant amount (>2.5 units or 30% on a 0 or 1 to 10 scale from baseline or less than 4 out of 10.
Analysis 1.3
Analysis 1.3
Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 3 Disability (RMDQ).
Analysis 1.4
Analysis 1.4
Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 4 Quality of life (QUALEFFO) [0 to 100].
Analysis 1.5
Analysis 1.5
Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 5 Treatment success.
Analysis 1.6
Analysis 1.6
Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 6 Quality of Life (EQ5D).
Analysis 2.1
Analysis 2.1
Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 1 Pain (0 or 1 to 10 point scale).
Analysis 2.2
Analysis 2.2
Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 2 Disability (RMDQ [0 to 24] or ODI [0 to 100]).
Analysis 2.3
Analysis 2.3
Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 3 Quality of Life (QUALEFFO).
Analysis 2.4
Analysis 2.4
Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 4 Quality of life (EQ5D).
Analysis 2.5
Analysis 2.5
Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 5 Treatment success.
Analysis 3.1
Analysis 3.1
Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 1 Pain (0 to 10 point scale).
Analysis 3.2
Analysis 3.2
Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 2 Disability (ODI).
Analysis 3.3
Analysis 3.3
Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 3 Quality of Life (EQ5D).
Analysis 4.1
Analysis 4.1
Comparison 4 Efficacy: Vertebroplasty versus facet joint injection, Outcome 1 Pain (0 to 10 point scale).
Analysis 4.2
Analysis 4.2
Comparison 4 Efficacy: Vertebroplasty versus facet joint injection, Outcome 2 Disability (RMDQ).
Analysis 4.3
Analysis 4.3
Comparison 4 Efficacy: Vertebroplasty versus facet joint injection, Outcome 3 Quality of Life (SF‐36).
Analysis 5.1
Analysis 5.1
Comparison 5 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 1 New clinical vertebral fractures.
Analysis 5.2
Analysis 5.2
Comparison 5 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 2 New radiographic vertebral fractures.
Analysis 5.3
Analysis 5.3
Comparison 5 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 3 Number of serious other adverse events.
Analysis 6.1
Analysis 6.1
Comparison 6 Safety: Vertebroplasty versus kyphoplasty, Outcome 1 New clinical vertebral fractures.
Analysis 6.2
Analysis 6.2
Comparison 6 Safety: Vertebroplasty versus kyphoplasty, Outcome 2 New radiographic vertebral fractures.
Analysis 6.3
Analysis 6.3
Comparison 6 Safety: Vertebroplasty versus kyphoplasty, Outcome 3 Number of serious other adverse events.
Analysis 7.1
Analysis 7.1
Comparison 7 Safety: Vertebroplasty versus facet joint injection, Outcome 1 New radiographic vertebral fractures.
Analysis 8.1
Analysis 8.1
Comparison 8 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 1 Pain at 1 to 2 weeks.
Analysis 8.2
Analysis 8.2
Comparison 8 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 2 Pain at 1 month.
Analysis 8.3
Analysis 8.3
Comparison 8 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 3 Disability at 1 to 2 weeks.
Analysis 8.4
Analysis 8.4
Comparison 8 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 4 Disability at 1 month.
Analysis 8.5
Analysis 8.5
Comparison 8 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 5 Quality of life (EQ‐5D) at 1 month.
Analysis 9.1
Analysis 9.1
Comparison 9 Sensitivity analysis, Outcome 1 Pain at 1 to 2 weeks (0 or 1 to 10 point scale).
Analysis 9.2
Analysis 9.2
Comparison 9 Sensitivity analysis, Outcome 2 Pain at 1 month (0 or 1 to 10 point scale).
Analysis 9.3
Analysis 9.3
Comparison 9 Sensitivity analysis, Outcome 3 Pain at 3 months (0 or 1 to 10 point scale).
Analysis 9.4
Analysis 9.4
Comparison 9 Sensitivity analysis, Outcome 4 Disability at 1 to 2 weeks (RMDQ [0 to 24] or ODI [0 to 100])).
Analysis 9.5
Analysis 9.5
Comparison 9 Sensitivity analysis, Outcome 5 Disability at 1 month (RMDQ [0 to 24] or ODI [0 to 100]).
Analysis 9.6
Analysis 9.6
Comparison 9 Sensitivity analysis, Outcome 6 Disability at 3 months (RMDQ [0 to 24] or ODI [0 to 100]).
See this image and copyright information in PMC

Update of

Comment in

References

References to studies included in this review

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References to studies awaiting assessment

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    1. NCT00749086. Prospective randomized study of balloon kyphoplasty and vertebroplasty in subacute (older than 6 weeks) osteoporotic vertebral fractures (STIC2). clinicaltrials.gov/show/NCT00749086 Trial registered: NCT00749086. Recruitment commenced Dec 2007. Trial completed June 2012.
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    1. NCT01963039. A trial of vertebroplasty for painful chronic osteoporotic vertebral fractures (VERTOS V). clinicaltrials.gov/show/NCT01963039 First registered 28 August 2013.

Additional references

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    1. Baumann A, Tauss J, Baumann G, Tomka M, Hessinger M, Tiesenhausen K. Cement embolization into the vena cava and pulmonal arteries after vertebroplasty: interdisciplinary management. European Journal of Vascular and Endovascular Surgery 2006;31(5):558‐61. - PubMed
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References to other published versions of this review

    1. Buchbinder R, Golmohammadi K, Johnston RV, Owen RJ, Homik J, Jones A, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database of Systematic Reviews 2015, Issue 4. [DOI: 10.1002/14651858.CD006349.pub2] - DOI - PubMed
    1. Lambert RGW, Golmohammadi K, Majumdar SR, Jones A, Buchbinder R, Dhillon SS, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database of Systematic Reviews 2007, Issue 1. [DOI: 10.1002/14651858.CD006349] - DOI - PubMed

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