Scolaris Content Display Scolaris Content Display

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Risk of bias summary: review authors' judgements about the risk of bias of the available evidence presented as percentages across all included studies.
Figures and Tables -
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.

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 1 Pain (0 to 10 point scale).
Figures and Tables -
Analysis 1.1

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 1 Pain (0 to 10 point scale).

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 2 Proportion with improvement in pain of 2.5 units or 30% or more from baseline.
Figures and Tables -
Analysis 1.2

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 2 Proportion with improvement in pain of 2.5 units or 30% or more from baseline.

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 3 Disability (RMDQ).
Figures and Tables -
Analysis 1.3

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 3 Disability (RMDQ).

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 4 Quality of life (QUALEFFO) [0 to 100].
Figures and Tables -
Analysis 1.4

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 4 Quality of life (QUALEFFO) [0 to 100].

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 5 Quality of Life (EQ5D).
Figures and Tables -
Analysis 1.5

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 5 Quality of Life (EQ5D).

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 6 Treatment success.
Figures and Tables -
Analysis 1.6

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 6 Treatment success.

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 1 Pain (0 or 1 to 10 point scale).
Figures and Tables -
Analysis 2.1

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 1 Pain (0 or 1 to 10 point scale).

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 2 Disability (RMDQ [0 to 24] or ODI [0 to 100]).
Figures and Tables -
Analysis 2.2

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 2 Disability (RMDQ [0 to 24] or ODI [0 to 100]).

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 3 Quality of Life (QUALEFFO).
Figures and Tables -
Analysis 2.3

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 3 Quality of Life (QUALEFFO).

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 4 Quality of life (EQ5D).
Figures and Tables -
Analysis 2.4

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 4 Quality of life (EQ5D).

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 1 Pain (0 to 10 point scale).
Figures and Tables -
Analysis 3.1

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 1 Pain (0 to 10 point scale).

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 2 Disability (ODI).
Figures and Tables -
Analysis 3.2

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 2 Disability (ODI).

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 3 Quality of Life (EQ5D).
Figures and Tables -
Analysis 3.3

Comparison 3 Efficacy: Vertebroplasty versus kyphoplasty (balloon), Outcome 3 Quality of Life (EQ5D).

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 1 New clinical vertebral fractures.
Figures and Tables -
Analysis 4.1

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 1 New clinical vertebral fractures.

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 2 New radiographic vertebral fractures.
Figures and Tables -
Analysis 4.2

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 2 New radiographic vertebral fractures.

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 3 Number of serious other adverse events.
Figures and Tables -
Analysis 4.3

Comparison 4 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 3 Number of serious other adverse events.

Comparison 5 Safety: Vertebroplasty versus kyphoplasty, Outcome 1 New clinical vertebral fractures.
Figures and Tables -
Analysis 5.1

Comparison 5 Safety: Vertebroplasty versus kyphoplasty, Outcome 1 New clinical vertebral fractures.

Comparison 5 Safety: Vertebroplasty versus kyphoplasty, Outcome 2 New radiographic vertebral fractures.
Figures and Tables -
Analysis 5.2

Comparison 5 Safety: Vertebroplasty versus kyphoplasty, Outcome 2 New radiographic vertebral fractures.

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 1 Pain at 1 to 2 weeks.
Figures and Tables -
Analysis 6.1

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 1 Pain at 1 to 2 weeks.

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 2 Pain at 1 month.
Figures and Tables -
Analysis 6.2

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 2 Pain at 1 month.

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 3 Disability at 1 to 2 weeks.
Figures and Tables -
Analysis 6.3

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 3 Disability at 1 to 2 weeks.

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 4 Disability at 1 month.
Figures and Tables -
Analysis 6.4

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 4 Disability at 1 month.

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 5 Quality of life (EQ‐5D) at 1 month.
Figures and Tables -
Analysis 6.5

Comparison 6 Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks, Outcome 5 Quality of life (EQ‐5D) at 1 month.

Comparison 7 Sensitivity analysis, Outcome 1 Pain at 1 to 2 weeks (0 to 10 scale).
Figures and Tables -
Analysis 7.1

Comparison 7 Sensitivity analysis, Outcome 1 Pain at 1 to 2 weeks (0 to 10 scale).

Comparison 7 Sensitivity analysis, Outcome 2 Pain at 1 month (0 to 10 scale).
Figures and Tables -
Analysis 7.2

Comparison 7 Sensitivity analysis, Outcome 2 Pain at 1 month (0 to 10 scale).

Comparison 7 Sensitivity analysis, Outcome 3 Pain at 3 months (0 to 10 scale).
Figures and Tables -
Analysis 7.3

Comparison 7 Sensitivity analysis, Outcome 3 Pain at 3 months (0 to 10 scale).

Comparison 7 Sensitivity analysis, Outcome 4 Disability at 1 to 2 weeks (RMDQ).
Figures and Tables -
Analysis 7.4

Comparison 7 Sensitivity analysis, Outcome 4 Disability at 1 to 2 weeks (RMDQ).

Comparison 7 Sensitivity analysis, Outcome 5 Disability at 1 month (RMDQ).
Figures and Tables -
Analysis 7.5

Comparison 7 Sensitivity analysis, Outcome 5 Disability at 1 month (RMDQ).

Comparison 7 Sensitivity analysis, Outcome 6 Disability at 3 months (RMDQ).
Figures and Tables -
Analysis 7.6

Comparison 7 Sensitivity analysis, Outcome 6 Disability at 3 months (RMDQ).

Summary of findings for the main comparison. Vertebroplasty for osteoporotic vertebral compression fracture

Vertebroplasty for osteoporotic vertebral compression fracture

Patient or population: people with osteoporotic vertebral compression fracture
Settings: hospital
Intervention: vertebroplasty versus sham

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Sham1

Vertebroplasty

Pain
Scale from: 0 to 10, 0 is best.
Follow‐up: 1 month

The mean pain in the control groups was
5 points

The mean pain in the intervention groups was
0.7 points better
(1.5 better to 0.15 worse)

201
(2 studies)

⊕⊕⊕⊝
moderate4

Absolute change 7% better (15% better to 1.5% worse); relative change 10% better (21% better to 2% worse); NNTB n/a2,3

Disability (Roland‐Morris Disability Questionnaire)
Scale from: 0 to 23; 0 is best.
Follow‐up: 1 month

The mean disability in the control groups was
13.6 points

The mean disability in the intervention groups was
1.09 better
(2.94 better to 0.76 worse)

201
(2 studies)

⊕⊕⊕⊝
moderate4

Absolute change 4.8% better (12.8% better to 3.3% worse); relative change 6.3% better (17.0% better to 4.4% worse); NNTB n/a2,3

Disease‐specific quality of Life (QUALEFFO)
Scale from: 0 to 100; 0 is best.
Follow‐up: 1 month

The mean quality of life (QUALEFFO) in the control groups was
2.4 points

The mean quality of life in the intervention groups was
0.40 points worse
(4.58 better to 5.38 worse)

73
(1 study)

⊕⊕⊕⊝
moderate4

Absolute change 0.4% worse (5% worse to 5% better); relative change: 0.7% worse (9% worse to 8% better); NNT n/a2,3

Overall quality of Life (EQ5D)
Scale from: 0 to 1; 1 is best.
Follow‐up: 1 month

The mean quality of life (EQ‐5D) in the control groups was
0.27 points

The mean quality of life in the intervention groups was
0.05 points better
(0.01 worse to 0.11 better)

201
(2 studies)

⊕⊕⊕⊝
moderate4

Absolute change 5% better (1% worse to 11% better); relative change: 18% improvement (4% worse to 39% better); NNT n/a2,3

Participant global assessment of success

(People perceived their pain as better)

Follow‐up: 1 month

225 per 1000

315 per 1000
(150 to 664)

RR 1.40
(0.67 to 2.95)

78
(1 study)

⊕⊕⊕⊝
moderate5

Absolute risk difference 9% more reported success (11% fewer to 29% more); relative change 40% more reported success (33% fewer to 195% more); NNTB n/a2

Incident vertebral fractures

Follow‐up: 12 months

138 per 1000

203 per 1000
(54 to 759)

RR 1.47
(0.39 to 5.50)

281
(3 studies)6

⊕⊕⊕⊝
moderate5

Absolute difference 6% more new fractures with vertebroplasty (2% fewer to 14% more); relative difference 47% more (61% fewer to 450% more); NNTH n/a2

Other serious adverse events
Follow‐up: 1 month

28 per 1000

29 per 1000
(6 to 136)

RR 1.01
(0.21 to 4.85)

209
(2 studies)

⊕⊕⊕⊝
moderate5

Absolute difference no more events with vertebroplasty (4% fewer to 4% more); relative change 1% more (79% fewer to 385% more); NNTH n/a2

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1For incident vertebral fractures the comparison includes one sham trial and two trials that compared vertebroplasty versus usual care.

2 Number needed to treat to benefit (NNTB), or harm (NNTH) not applicable (n/a) when result is not statistically significant. NNT for dichotomous outcomes calculated using Cates NNT calculator (http://www.nntonline.net/visualrx/). NNT for continuous outcomes calculated using Wells Calculator (CMSG editorial office)

3 Relative changes calculated as absolute change (mean difference) divided by mean at baseline in the placebo group from Buchbinder 2009 (values were: 7.1 points on 0 to 10 point VAS pain; 17.3 points on 0 to 23 point Roland‐Morris Disability questionnaire; 0.28 points on EQ‐5D quality of life scale; 59.6 points on the QUALEFFO scale)

4 Downgraded due to imprecision: the 95% confidence intervals do not exclude a clinically important change (defined as 1.5 points on 0 to 10 point VAS pain scale; 2 to 3 points on the 0 to 23 point RDQ scale; 0.074 on the 0 to 1 EQ‐5D quality of life scale, and 10 points on the 0 to 100 QUALEFFO scale), or the total number of participants was small, from a single trial only

5 Total number of events small

6 Pooled both placebo and usual care comparisons in the safety analyses.

Figures and Tables -
Summary of findings for the main comparison. Vertebroplasty for osteoporotic vertebral compression fracture
Table 1. Study characteristics of unpublished, ongoing and suspended or terminated trials

Trial registration number

Principle Investigator/s and Country

Comparator/s

Main selection criteria

Registration date

Recruitment commenced

Status 24 November 2014

Planned sample size

Final sample size

NCT01482793

Clark W, Bird P

Australia

Sham

Age > 60 years

Fracture < 6 weeks

28 Nov 2011

Nov 2011

Recruiting (last verified Nov 2011)

120

NCT00749060

‘OSTEO‐6’

Laredo JD

France

Kyphoplasty; Usual care with or without brace

Age ≥ 50 years

Fracture < 6 weeks

8 Sept 2008

Dec 2007

Completed June 2012; results unpublished

300

48

NCT00749086

‘STIC2’

Laredo JD

France

Kyphoplasty

Age ≥ 50 years

Fracture > 6 weeks

8 Sept 2008

Dec 2007

Completed June 2012; results unpublished

200

97

NCT00635297

Nakstad PH

Norway

Vertebroplasty of fractured vertebra +/‐ additional vertebroplasty to adjacent vertebrae

Age > 50 years

5 Mar 2008

Apr 2008

Suspended, reason not stated (last updated 2 Mar 2010)

100

NCT00203554

Sorensen L

Denmark

Usual care

Fracture < 6 months

16/09/2005

Mar 2004

Completed Jan 2008; results unpublished

27

27

ISRCTN14442024

(Also

N0213112414)

Dolin, S

UK

Usual care

Fracture > 4 weeks

12 Sep 2003

Nov 28 2005

Completed (last updated 6 Feb 2014); results unpublished

Not provided

Not provided

chiCTR‐TRC‐14004835

Zhao J, Liu B

China

Ordinary vs high viscosity cement

Includes osteoporotic fractures, haemangiomas and metastatic disease

23 Jun 2014

Planned 1 Jan 2015

Not yet recruiting

100

NCT01677806

Sun G

China

Usual care

Age ≥ 50 years

Fracture < 6 weeks

23 Aug 2012

Oct 2012

Recruiting (last updated 7 Aug 2014)

114

NCT01537770 (also EUCTR2010‐024050‐10‐DK

‘VOPE’

Hansen EJ,

Andersen MO, Rousing R, Tropp H

Denmark

Lidocaine

Age > 50 years

6 Jan 2011

Feb 2012

No longer recruiting (last updated 21 Oct 2014)

80

NTR3282

Nieuwenhuijse MJ Netherlands

Low vs high viscosity cement

14 Feb 2012

Jan 2011

Recruiting (last updated 21 July 2014)

86

NCT01200277

‘VERTOS IV’

van Rooij HJ, De Vries J,

Lohle PN

Netherlands

Sham

Age ≥ 50 years

Fracture ≤ 6 weeks

7 Sept 2010

Jan 2011

Completed (last updated 19 Nov 2014)

80

NCT00279877

Evans A

USA

Kyphoplasty

18 Jan 2006

May 2005

Completed May 2011; results unpublished

112

Not provided

Registration details not found.

Longo UG

Italy

3 weeks bed rest, rigid hyperextension corset, followed by 2‐3 months in a Cheneau brace (called ‘double‐blind)

Age ≥ 50 years

Trial registration not found

Unknown

Unknown (protocol published)

200

NCT01963039

‘VERTOS V’

Carli D

Netherlands

Sham

Age ≥ 50 years

Fracture ≥ 12 weeks

28 Aug 2013

May 2013

Recruiting (last updated Oct 2013)(protocol published)

94

Registration details not found. Results published as conference abstract*

Hao, D, Guo, H, Wang, B, Wang X
China

Facet joint block

Age ≥55 years

Fracture ≤ 8 weeks

Trial registration not found

Jan 2009

Recruitment completed Jan 2013

Not stated

206 (100 in VP; 106 in facet block group)

* Abstract reported that analysis favoured vertebroplasty at 1 day and 1 week for pain and disability measured by RMDQ and ODI but no between‐group differences at 1, 3, 6, 12 months for pain, RMDQ, ODI and SF‐36 function and SF‐36 physical and mental component scores. After 12 months follow‐up, there were 13 new fractures in the percutaneous vertebroplasty group and 11 new fractures in the facet joint block group. Abstract did not report method of randomisation, whether or not treatment allocation was concealed and whether or not participants and investigators were blinded to treatment allocation.

Figures and Tables -
Table 1. Study characteristics of unpublished, ongoing and suspended or terminated trials
Table 2. Baseline demographic and clinical characteristics of the trial participants

Study

Country

Treatment Groups

Mean age, yrs

Mean symptom duration

Mean (SD) baseline pain (0‐10 scale$)

Mean (SD) baseline RMDQ+ (0‐24 scale)

Mean (SD) baseline QUALEFFO (0‐100 scale)

Procedures performed by

Mean (range) volume cement injected (mL)

Follow‐up

Blasco 2012

Spain

Vertebroplasty

71.3

140.3 days

7.2 (0.3)

65.2 (2.2)

Interventional radiologists

Not specified

2 weeks, 2, 6, 12 months

Usual care

71.3

143.1 days

6.3 (0.4)

59.2 (2.2)

Buchbinder 2009

Australia

Vertebroplasty

74.2

9 weeks^

7.4 (2.1)

17.3 (2.8)

56.9 (13.4)

Interventional radiologists

2.8 (1.2 ‐ 5.5)

1 week, 1, 3, 6, 12, 24 months

Placebo

78.9

9.5 weeks^

7.1 (2.3)

17.3 (2.9)

59.6 (17.1)

Chen 2014

China

Vertebroplasty

64.6

31 weeks

6.5 (0.9)&

18.6 (1.8)#&

Orthopaedic surgeons

3.6 (3 ‐ 6)

1 day, 1 week, 1, 3, 6, 12 months

Usual care and brace

66.5

29.5 weeks

6.4 (0.9)&

16.7 (1.3)#&

Dohm 2014

USA and Canada

Vertebroplasty

75.7

‐¤

˜7.6µ

Interventional radiologists and neuroradiologists, orthopaedic surgeons, neuroradiologists

4.0 (3.0 to 6.0)¢

7 days, 1, 3, 12 and 24 months

Balloon kyphoplasty

75.5

‐¤

˜7.6µ

Not stated

4.6 (3.4 to 6.0)¢

Endres 2012

Germany

Vertebroplasty

71.3

§

7.8 (0.9)

Orthopaedic surgeon

3.1 (2 – 4)

Immediately, mean 5.8 months (range: 4 to 7)

Balloon kyphoplasty

63.3

§

9.0 (0.7)

Orthopaedic surgeon

3.9 (3 – 5)

Shield kyphoplasty

67.1

§

8.8 (1.5)

Orthopaedic surgeon

4.6 (3 – 6)

Farrokhi 2011

Iran

Vertebroplasty

72

27 weeks

8.4 (1.6)

Neurosurgeons

3.5 (1 ‐ 5.5)

1 week, 2, 6, 12, 24, 36 months

Usual care

74

30 weeks

7.2 (1.7)

Kallmes 2009

US, UK, Australia

Vertebroplasty

73.4

16 weeks

6.9 (2.0)

16.6 (3.8)

Interventional radiologists

2.8 (1 ‐ 5.5)*

3 days, 2 weeks, 1 month

Placebo

73.3

20 weeks

7.2 (2.0)

17.5 (4.1)

Klazen 2010

Netherlands, Belgium

Vertebroplasty

75.2

29.3 days

7.8 (1.5)

18.6 (3.6)#

58.7 (13.5)

Interventional radiologists

4.1 (1 ‐ 9)

1 day, 1 week, 1, 3, 6, 12 months

Usual care

75.4

26.8 days

7.5 (1.6)

17.2 (4.2)#

54.7 (14.4)

Liu 2010

Taiwan

Vertebroplasty

74.3

15.8 days

7.9 (0.7)

Not stated

4.9 (0.7)

3 days, 6 months

Balloon kyphoplasty

72.3

17.0 days

8.0 (0.8)

Not stated

5.6 (0.6)

Rousing 2009

Denmark

Vertebroplasty

80

8.4 days

7.5 (2.0)

Orthopedic surgeons

Not specified

3 months

Usual care and brace

80

6.7 days

8.8 (1.2)

Vogl 2013

Germany and USA

Vertebroplasty

74

¥

8.5 (1.2)

Not stated

4.0 (1.1)

1 day, 3, 12 months

Shield kyphoplasty

80

¥

8.3 (1.1)

Not stated

3.8 (0.7)

Voormolen 2007

Netherlands

Vertebroplasty

72

85 days

7.1 (5 ‐ 9)+

15.7 (8‐24)

60.0 (37 to 86)+

Interventional radiologists

3.2 (1.0 ‐ 5.0)

2 weeks

Usual care

74

76 days

7.6 (5‐10)

17.8 (8‐22)

60.7 (38 to 86)

$1‐10 point scale used by Farrokhi 2011; +RMDQ: Roland Morris Disability Questionnaire; modified RMDQ (0‐23 scale) used by Buchbinder 2009 and Kallmes 2009; ^ median duration of symptoms; ¤Not reported but symptom duration 6 months or less; µMean symptom duration reported graphically only; ¢Median and interquartile range;§Not reported but symptom duration 6 weeks or less; &Data only included for the 42/46 in VP group and 43/50 in the usual care group who completed 12‐month follow‐up in groups assigned to at baseline; #Disability significantly higher in the vertebroplasty group; *from n = 20 treated at Mayo (personal communication); ¥Not reported but at least 6 weeks of conservative treatment; +Only range provided.

Figures and Tables -
Table 2. Baseline demographic and clinical characteristics of the trial participants
Comparison 1. Efficacy: Vertebroplasty versus placebo (sham)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain (0 to 10 point scale) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 1 to 2 weeks

2

205

Mean Difference (IV, Random, 95% CI)

0.12 [‐0.65, 0.88]

1.2 1 month

2

201

Mean Difference (IV, Random, 95% CI)

‐0.66 [‐1.48, 0.15]

1.3 3 months

1

73

Mean Difference (IV, Random, 95% CI)

‐0.70 [‐2.12, 0.72]

1.4 6 months

1

71

Mean Difference (IV, Random, 95% CI)

‐0.30 [‐1.84, 1.24]

1.5 12 months

1

67

Mean Difference (IV, Random, 95% CI)

‐0.5 [‐1.82, 0.82]

1.6 24 months

1

57

Mean Difference (IV, Random, 95% CI)

‐1.1 [‐2.68, 0.48]

2 Proportion with improvement in pain of 2.5 units or 30% or more from baseline Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 Pain improved at 1 week

1

78

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.58, 1.90]

2.2 Pain improved at 1 month

2

206

Risk Ratio (M‐H, Random, 95% CI)

1.27 [0.97, 1.66]

2.3 Pain improved at 3 months

1

78

Risk Ratio (M‐H, Random, 95% CI)

1.54 [0.89, 2.66]

2.4 Pain improved at 6 months

1

78

Risk Ratio (M‐H, Random, 95% CI)

1.33 [0.80, 2.22]

2.5 Pain improved at 12 months

1

78

Risk Ratio (M‐H, Random, 95% CI)

1.21 [0.67, 2.20]

2.6 Pain improved as 24 months

1

78

Risk Ratio (M‐H, Random, 95% CI)

1.43 [0.84, 2.42]

3 Disability (RMDQ) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 1 to 2 weeks

2

190

Mean Difference (IV, Random, 95% CI)

0.82 [‐1.13, 2.78]

3.2 1 month

2

187

Mean Difference (IV, Random, 95% CI)

‐1.09 [‐2.94, 0.76]

3.3 3 months

1

59

Mean Difference (IV, Random, 95% CI)

1.60 [‐1.66, 4.86]

3.4 6 months

1

59

Mean Difference (IV, Random, 95% CI)

‐0.40 [‐3.36, 2.56]

3.5 12 months

1

48

Mean Difference (IV, Random, 95% CI)

0.60 [‐3.02, 4.22]

3.6 24 months

1

43

Mean Difference (IV, Random, 95% CI)

0.10 [‐3.67, 3.87]

4 Quality of life (QUALEFFO) [0 to 100] Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

4.1 1 week

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.2 1 month

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.3 3 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.4 6 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.5 12 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4.6 24 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

5 Quality of Life (EQ5D) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

5.1 1 to 2 weeks

1

59

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.15, 0.15]

5.2 1 month

2

187

Mean Difference (IV, Random, 95% CI)

0.05 [‐0.01, 0.11]

5.3 3 months

1

59

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.18, 0.18]

5.4 6 months

1

59

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.20, 0.20]

5.5 12 months

1

47

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.23, 0.23]

5.6 24 months

1

44

Mean Difference (IV, Random, 95% CI)

0.0 [‐0.24, 0.24]

6 Treatment success Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

6.1 1 week

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.2 1 month

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.3 3 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.4 6 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.5 12 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6.6 24 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 1. Efficacy: Vertebroplasty versus placebo (sham)
Comparison 2. Efficacy: Vertebroplasty versus usual care (open label)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain (0 or 1 to 10 point scale) Show forest plot

6

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 1 to 2 weeks

5

520

Std. Mean Difference (IV, Random, 95% CI)

‐1.07 [‐2.01, ‐0.14]

1.2 1 month

2

277

Std. Mean Difference (IV, Random, 95% CI)

‐1.62 [‐3.01, ‐0.24]

1.3 2 to 3 months

5

520

Std. Mean Difference (IV, Random, 95% CI)

‐0.90 [‐1.59, ‐0.21]

1.4 6 months

4

466

Std. Mean Difference (IV, Random, 95% CI)

‐0.88 [‐1.71, ‐0.04]

1.5 12 months

5

505

Std. Mean Difference (IV, Random, 95% CI)

‐0.83 [‐1.55, ‐0.11]

1.6 24 months

1

77

Std. Mean Difference (IV, Random, 95% CI)

‐0.45 [‐0.90, 0.01]

2 Disability (RMDQ [0 to 24] or ODI [0 to 100]) Show forest plot

5

Std. Mean Difference (IV, Random, 95% CI)

Subtotals only

2.1 1 to 2 weeks

4

387

Std. Mean Difference (IV, Random, 95% CI)

‐2.04 [‐3.57, ‐0.50]

2.2 1 month

2

271

Std. Mean Difference (IV, Random, 95% CI)

‐0.94 [‐2.30, 0.43]

2.3 3 months

4

396

Std. Mean Difference (IV, Random, 95% CI)

‐1.90 [‐3.76, ‐0.04]

2.4 6 months

3

354

Std. Mean Difference (IV, Random, 95% CI)

‐1.69 [‐3.55, 0.17]

2.5 12 months

4

389

Std. Mean Difference (IV, Random, 95% CI)

‐1.26 [‐2.61, 0.08]

2.6 24 months

1

77

Std. Mean Difference (IV, Random, 95% CI)

‐5.65 [‐6.67, ‐4.63]

3 Quality of Life (QUALEFFO) Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 1 to 2 weeks

3

341

Mean Difference (IV, Random, 95% CI)

‐4.01 [‐11.77, 3.75]

3.2 1 month

1

182

Mean Difference (IV, Random, 95% CI)

‐4.21 [‐8.86, 0.44]

3.3 2 to 3 months

2

308

Mean Difference (IV, Random, 95% CI)

‐1.61 [‐8.10, 4.88]

3.4 6 months

2

308

Mean Difference (IV, Random, 95% CI)

‐0.83 [‐6.48, 4.83]

3.5 12 months

2

308

Mean Difference (IV, Random, 95% CI)

‐0.46 [‐5.09, 4.18]

4 Quality of life (EQ5D) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 1 to 2 weeks

1

183

Mean Difference (IV, Random, 95% CI)

0.08 [0.00, 0.15]

4.2 1 month

1

183

Mean Difference (IV, Random, 95% CI)

0.09 [0.01, 0.16]

4.3 3 months

2

215

Mean Difference (IV, Random, 95% CI)

0.10 [0.00, 0.20]

4.4 6 months

1

183

Mean Difference (IV, Random, 95% CI)

0.07 [‐0.02, 0.15]

4.5 12 months

2

215

Mean Difference (IV, Random, 95% CI)

0.07 [‐0.00, 0.14]

Figures and Tables -
Comparison 2. Efficacy: Vertebroplasty versus usual care (open label)
Comparison 3. Efficacy: Vertebroplasty versus kyphoplasty (balloon)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain (0 to 10 point scale) Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 1 to 2 weeks

1

364

Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.75, 0.35]

1.2 1 month

1

342

Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.69, 0.49]

1.3 3 months

1

314

Mean Difference (IV, Random, 95% CI)

‐0.10 [‐0.74, 0.54]

1.4 6 months

2

141

Mean Difference (IV, Random, 95% CI)

‐0.08 [‐0.41, 0.24]

1.5 12 months

1

275

Mean Difference (IV, Random, 95% CI)

0.30 [‐0.40, 1.00]

1.6 24 months

1

220

Mean Difference (IV, Random, 95% CI)

0.10 [‐0.72, 0.92]

2 Disability (ODI) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 1 month

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 3 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.3 12 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.4 24 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 Quality of Life (EQ5D) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 1 month

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 3 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 12 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 24 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 3. Efficacy: Vertebroplasty versus kyphoplasty (balloon)
Comparison 4. Safety: Vertebroplasty versus placebo (sham) or usual care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 New clinical vertebral fractures Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 12 months

3

281

Risk Ratio (M‐H, Random, 95% CI)

1.47 [0.39, 5.50]

1.2 24 months

2

134

Risk Ratio (M‐H, Random, 95% CI)

0.54 [0.09, 3.38]

2 New radiographic vertebral fractures Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 12 months

4

397

Risk Ratio (M‐H, Random, 95% CI)

1.43 [0.55, 3.74]

2.2 24 months

1

43

Risk Ratio (M‐H, Random, 95% CI)

1.48 [0.90, 2.44]

3 Number of serious other adverse events Show forest plot

2

209

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.21, 4.85]

Figures and Tables -
Comparison 4. Safety: Vertebroplasty versus placebo (sham) or usual care
Comparison 5. Safety: Vertebroplasty versus kyphoplasty

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 New clinical vertebral fractures Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

1.1 24 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2 New radiographic vertebral fractures Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

2.1 12 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 24 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Figures and Tables -
Comparison 5. Safety: Vertebroplasty versus kyphoplasty
Comparison 6. Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain at 1 to 2 weeks Show forest plot

2

201

Mean Difference (IV, Random, 95% CI)

0.19 [‐0.58, 0.95]

1.1 Duration pain ≤ 6 weeks

2

44

Mean Difference (IV, Random, 95% CI)

0.64 [‐0.97, 2.26]

1.2 Duration pain > 6 weeks

2

157

Mean Difference (IV, Random, 95% CI)

0.05 [‐0.81, 0.92]

2 Pain at 1 month Show forest plot

2

201

Mean Difference (IV, Random, 95% CI)

‐0.66 [‐1.44, 0.13]

2.1 Duration pain ≤ 6 weeks

2

44

Mean Difference (IV, Random, 95% CI)

0.04 [‐1.80, 1.87]

2.2 Duration pain > 6 weeks

2

157

Mean Difference (IV, Random, 95% CI)

‐0.81 [‐1.68, 0.05]

3 Disability at 1 to 2 weeks Show forest plot

2

182

Mean Difference (IV, Random, 95% CI)

0.64 [‐0.88, 2.15]

3.1 Duration pain ≤ 6 weeks

2

41

Mean Difference (IV, Random, 95% CI)

0.20 [‐3.33, 3.72]

3.2 Duration pain > 6 weeks

2

141

Mean Difference (IV, Random, 95% CI)

0.74 [‐0.94, 2.42]

4 Disability at 1 month Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 Duration pain ≤ 6 weeks

2

41

Mean Difference (IV, Random, 95% CI)

‐0.43 [‐4.02, 3.16]

4.2 Duration pain > 6 weeks

2

142

Mean Difference (IV, Random, 95% CI)

‐0.83 [‐2.87, 1.21]

5 Quality of life (EQ‐5D) at 1 month Show forest plot

2

183

Mean Difference (IV, Random, 95% CI)

0.04 [‐0.01, 0.10]

5.1 Duration pain ≤ 6 weeks

2

41

Mean Difference (IV, Random, 95% CI)

0.05 [‐0.07, 0.16]

5.2 Duration pain > 6 weeks

2

142

Mean Difference (IV, Random, 95% CI)

0.04 [‐0.02, 0.10]

Figures and Tables -
Comparison 6. Subgroup analysis: Duration pain ≤ 6 weeks versus > 6 weeks
Comparison 7. Sensitivity analysis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain at 1 to 2 weeks (0 to 10 scale) Show forest plot

7

725

Std. Mean Difference (IV, Random, 95% CI)

‐0.43 [‐0.91, 0.06]

1.1 Sham (placebo) control

2

205

Std. Mean Difference (IV, Random, 95% CI)

0.04 [‐0.24, 0.31]

1.2 Usual care (open label) control

5

520

Std. Mean Difference (IV, Random, 95% CI)

‐0.64 [‐1.27, ‐0.00]

2 Pain at 1 month (0 to 10 scale) Show forest plot

4

478

Std. Mean Difference (IV, Random, 95% CI)

‐0.91 [‐1.71, ‐0.12]

2.1 Sham (placebo) control

2

201

Std. Mean Difference (IV, Random, 95% CI)

‐0.22 [‐0.50, 0.06]

2.2 Usual care (open label) control

2

277

Std. Mean Difference (IV, Random, 95% CI)

‐1.62 [‐3.01, ‐0.24]

3 Pain at 3 months (0 to 10 scale) Show forest plot

6

593

Std. Mean Difference (IV, Random, 95% CI)

‐0.79 [‐1.38, ‐0.20]

3.1 Sham (placebo) control

1

73

Std. Mean Difference (IV, Random, 95% CI)

‐0.22 [‐0.68, 0.24]

3.2 Usual care (open label) control

5

520

Std. Mean Difference (IV, Random, 95% CI)

‐0.90 [‐1.59, ‐0.21]

4 Disability at 1 to 2 weeks (RMDQ) Show forest plot

5

510

Mean Difference (IV, Random, 95% CI)

‐1.60 [‐3.32, 0.12]

4.1 Sham (placebo) control

2

205

Mean Difference (IV, Random, 95% CI)

0.94 [‐1.08, 2.96]

4.2 Usual care (open label) control

3

305

Mean Difference (IV, Random, 95% CI)

‐2.82 [‐4.12, ‐1.53]

5 Disability at 1 month (RMDQ) Show forest plot

4

472

Mean Difference (IV, Random, 95% CI)

‐1.26 [‐2.51, ‐0.00]

5.1 Sham (placebo) control

2

201

Mean Difference (IV, Random, 95% CI)

0.12 [‐2.40, 2.64]

5.2 Usual care (open label) control

2

271

Mean Difference (IV, Random, 95% CI)

‐2.05 [‐2.56, ‐1.54]

6 Disability at 3 months (RMDQ) Show forest plot

3

344

Mean Difference (IV, Random, 95% CI)

‐1.64 [‐3.52, 0.24]

6.1 Sham (placebo) control

1

73

Mean Difference (IV, Random, 95% CI)

1.60 [‐1.31, 4.51]

6.2 Usual care (open label) control

2

271

Mean Difference (IV, Random, 95% CI)

‐2.59 [‐3.04, ‐2.15]

Figures and Tables -
Comparison 7. Sensitivity analysis