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Meta-Analysis
. 2018 Nov 6;11(11):CD006349.
doi: 10.1002/14651858.CD006349.pub4.

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

Affiliations
Meta-Analysis

Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

Rachelle Buchbinder et al. Cochrane Database Syst Rev. .

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.Four placebo-controlled trials were at low risk of bias and one was 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 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 0.7 points better (0.3 better to 1.2 better) with vertebroplasty, an absolute pain reduction of 7% (3% better to 12% better, minimal clinical important difference is 15%) and relative reduction of 10% (4% better to 17% 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 1.5 points better (0.4 better to 2.6 better) in the vertebroplasty group, absolute improvement 7% (2% to 11% better), relative improvement 9% better (2% to 15% better) (four trials, 472 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 2.3 points better (1.4 points worse to 6.7 points better), an absolute imrovement of 2% (1% worse to 6% better); relative improvement 4% better (2% worse to 10% better) (three trials, 351 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).Low-quality evidence (downgraded due to imprecision and potential for bias from the usual-care controlled trials) indicates uncertainty around the risk estimates of harms with vertebroplasty. The incidence of new symptomatic vertebral fractures (from six trials) was 48/418 (95 per 1000; range 34 to 264)) in the vertebroplasty group compared with 31/422 (73 per 1000) in the control group; RR 1.29 (95% CI 0.46 to 3.62)). The incidence of other serious adverse events (five trials) was 16/408 (34 per 1000, range 18 to 62) in the vertebroplasty group compared with 23/413 (56 per 1000) in the control group; RR 0.61 (95% CI 0.33 to 1.10). 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 (acute versus subacute). 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: We found high- to moderate-quality evidence that vertebroplasty has no important benefit in terms of pain, disability, quality of life or treatment success in the treatment of acute or subacute osteoporotic vertebral fractures in routine practice when compared with a sham procedure. Results were consistent across the studies irrespective of the average duration of pain.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. R Buchbinder and D Kallmes did not perform risk of bias assessments for their own or any other placebo‐controlled trials included in the review.

Figures

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

Update of

Comment in

References

References to studies included in this review

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Dohm 2014 {published data only}
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Endres 2012 {published data only}
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Kallmes 2009 {published data only}
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Klazen 2010 {published data only}
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Leali 2016 {published and unpublished data}
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Liu 2010 {published data only}
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Rousing 2009 {published data only}
    1. Rousing R, Andersen MO, Jespersen SM, Thomsen K, Lauritsen J, Rousing Rikke, et al. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three‐months follow‐up in a clinical randomized study. Spine 2009;34(13):1349‐54. - PubMed
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Sun 2016 {published and unpublished data}
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Vogl 2013 {published data only}
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Voormolen 2007 {published data only}
    1. Voormolen MH, Lohle PN, Fransen H, Juttmann JR, Waal Malefijt J, Lampmann LE. [Percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures: first short term results]. Nederlands Tijdschrift Voor Geneeskunde 2003;147(32):1549‐53. - PubMed
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VOPE 2015 {unpublished data only}
    1. Hansen EJ. A double‐blind randomized clinical study comparing vertebroplasty with a SHAM procedure for acute osteoporotic vertebral compression fractures (VOPE). Thesis, University of Southern Denmark: Center for Spine Surgery and Research, Middelfart Hospital and Institute of Regional Health Research, University of Southern Denmark, Denmark 2015.
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Wang 2015 {published data only}
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Wang 2016 {published data only}
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Yang 2016 {published data only}
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References to studies excluded from this review

Cai 2015 {published data only}
    1. Cai J, Hao YW, Li C, Yang HQ. Percutaneous vertebroplasty with bone cement injection for osteoporotic vertebral compression fractures via transpedicular approach [Chinese]. Chinese Journal of Tissue Engineering Research 2015;19(30):4892‐7.
Chen 2014b {published data only}
    1. Chen C, Bian J, Zhang W, Zhao C, Wei H. Unilateral versus bilateral vertebroplasty for severe osteoporotic vertebral compression fractures. Journal of Spinal Disorders & Techniques 2014;27(8):E301‐4. - PubMed
Chun‐lei 2015 {published data only}
    1. Chen‐lei L, Yi‐he H, Gui‐qing W, Yong‐zhi T, Xiang‐jiang W, Han‐tao H. Curative effects of unipedicular and bipedicular vertebroplasty in treating osteoporotic vertebral compression fractures in the elderly population. Journal of Xi'an Jiatong University 2015;36:6.
Du 2014 {published data only}
    1. Du J, Li X, Lin X. Kyphoplasty versus vertebroplasty in the treatment of painful osteoporotic vertebral compression fractures: two‐year follow‐up in a prospective controlled study. Acta Orthopaedica Belgica 2014;80(4):477‐86. - PubMed
Gilula 2013 {published data only}
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Gu 2015 {published data only}
    1. Gu YT, Zhu DH, Liu HF, Zhang F, McGuire R. Minimally invasive pedicle screw fixation combined with percutaneous vertebroplasty for preventing secondary fracture after vertebroplasty. Journal of Orthopaedic Surgery 2015;10:31 doi: 10.1186/s13018‐015‐0172‐1. [DOI: 10.1186/s13018-015-0172-1] - DOI - PMC - PubMed
Huang 2014 {published data only}
    1. Huang XN. Percutaneous vertebroplasty for treatment of osteoporotic vertebral fractures: High‐viscosity versus low‐viscosity bone cement [Chinese]. Chinese Journal of Tissue Engineering Research 2014;18(16):2461‐7.
Li 2015a {published data only}
    1. Li J, Shen WL, Chang XH. Comparison of clinical effects between unilateral and bilateral percutaneous vertebroplasty for osteoporotic vertebral compression fractures. [Chinese]. Journal of Dalian Medical University 2015;37(2):145‐7.
Liu 2015 {published data only}
    1. Liu CL, Hu YH, Wang GQ, Tang YZ, Wang XJ, Hou HT. Curative effects of unipedicular and bipedicular vertebroplasty in treating osteoporotic vertebral compression fractures in the elderly population. [Chinese]. Journal of Xi'an Jiaotong University (Medical Sciences) 2015;36(6):857‐61.
Min 2015 {published data only}
    1. Min P, Zhang YP, Cao H. CT‐guided bone cement injection combined with artificial tiger bone meal to repair osteoporotic vertebral compression fractures: Callus growth and bone healing [Chinese]. Chinese Journal of Tissue Engineering Research 2015;19(3):335‐9.
Son 2014 {published data only}
    1. Son S, Lee SG, Kim WK, Park CW, Yoo CJ. Early vertebroplasty versus delayed vertebroplasty for acute osteoporotic compression fracture: Are the results of the two surgical strategies the same?. Journal of Korean Neurosurgical Society 2014;56(3):211‐7. - PMC - PubMed
Xiao‐nan 2014 {published data only}
    1. Xiao‐nan H. Percutaneous vertebroplasty for treatment of osteoporotic vertebral fractures: high viscosity versus low‐viscosity bone cement. Chinese Journal of Tissue Engineering Research 2014;18(16):2461‐7.
Yang 2014 {published data only}
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Yi 2014 {published data only}
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Ying 2017 {published data only}
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Yokoyama 2016 {published data only}
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Zhang 2015a {published data only}
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Zhang 2015b {published data only}
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Zhang 2015c {published data only}
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References to studies awaiting assessment

Chen 2015 {published data only}
    1. Chen JP, Qi XW, Li SJ, Kuang LP, Yuan XH, Wang GS, et al. Bone cement injection as vertebral augmentation therapy for osteoporotic vertebral compression fractures. [Chinese]. Chinese Journal of Tissue Engineering Research 2015;19(21):3292‐6. [DOI: ]
Dolin 2003 {unpublished data only}
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Laredo (OSTEO‐6) {unpublished data only}
    1. NCT00749060. Prospective randomized comparative study of balloon kyphoplasty, vertebroplasty and conservative management in acute osteoporotic vertebral fractures of less than 6 weeks. clinicaltrials.gov/show/NCT00749060 (first received September 8, 2008) Trial completed June 2012.
Laredo (STIC2) {unpublished data only}
    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.
Li 2015b {published data only}
    1. Li DH, Liu XW, Peng XT, Wang ZG, Wang BC, Jin P, et al. Bone filling mesh container for treatment of vertebral compression fractures can reduce the leakage of bone cement. [Chinese]. Chinese Journal of Tissue Engineering Research 15 Jan 2015;19(3):358‐3.
Sorensen 2005 {unpublished data only}
    1. NCT00203554. Percutaneous vertebroplasty versus conservative treatment of pain: a prospective, randomized controlled study of osteoporotic fractures in the spine. clinicaltrials.gov/show/NCT00203554 (first received 16 September 2005).
Tan 2016 {published data only}
    1. Tan B, Liu XW, Liu G, Li YS, Qin ZJ, Yang CP. Percutaneous kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral compression fractures: A randomized comparison [Chinese]. Chinese Journal of Tissue Engineering Research 2016;20(4):539‐43.
Zhou 2015 {published data only}
    1. Zhou W. Percutaneous vertebroplasty with high‐viscosity bone cement for treatment of severe osteoporotic thoracolumbar vertebral compression fractures [Chinese]. Chinese Journal of Tissue Engineering Research 2015;19(46):7534‐8.

References to ongoing studies

Longo 2010 {unpublished data only}
    1. Longo UG, Loppini M, Denaro L, Brandi ML, Maffulli N, Denaro V. The effectiveness and safety of vertebroplasty for osteoporotic vertebral compression fractures. A double blind, prospective, randomized, controlled study. Clinical Cases in Mineral and Bone Metabolism : the official journal of the Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases 2010;7(2):109‐13. [PUBMED: 22460014] - PMC - PubMed
Sun 2012 {unpublished data only}
    1. NCT01677806. Investigational percutaneous vertebroplasty efficacy and safety trial. clinicaltrials.gov/show/NCT01677806 (first received 23 August 2012).
VERTOS V {unpublished data only}
    1. NCT01963039. A trial of vertebroplasty for painful chronic osteoporotic vertebral fractures (VERTOS V). clinicaltrials.gov/show/NCT01963039 First registered 28 August 2013.

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References to other published versions of this review

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