Percutaneous vertebroplasty for osteoporotic vertebral compression fracture

Rachelle Buchbinder; Renea V Johnston; Kobi J Rischin; Joanne Homik; C Allyson Jones; Kamran Golmohammadi; David F Kallmes

doi:10.1002/14651858.CD006349.pub4

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Figure 1

Study flow diagram.

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Figure 2

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

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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.

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Analysis 1.1

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

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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.

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Analysis 1.3

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

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Analysis 1.4

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

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Analysis 1.5

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 5 Treatment success.

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Analysis 1.6

Comparison 1 Efficacy: Vertebroplasty versus placebo (sham), Outcome 6 Quality of Life (EQ5D).

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Analysis 2.1

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

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Analysis 2.2

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

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Analysis 2.3

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

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Analysis 2.4

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

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Analysis 2.5

Comparison 2 Efficacy: Vertebroplasty versus usual care (open label), Outcome 5 Treatment success.

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Analysis 3.1

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

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Analysis 3.2

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

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Analysis 3.3

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

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Analysis 4.1

Comparison 4 Efficacy: Vertebroplasty versus facet joint injection, Outcome 1 Pain (0 to 10 point scale).

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Analysis 4.2

Comparison 4 Efficacy: Vertebroplasty versus facet joint injection, Outcome 2 Disability (RMDQ).

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Analysis 4.3

Comparison 4 Efficacy: Vertebroplasty versus facet joint injection, Outcome 3 Quality of Life (SF‐36).

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$Comparison 5 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 1 New clinical vertebral fractures.$

Analysis 5.1

Comparison 5 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 1 New clinical vertebral fractures.

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$Comparison 5 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 2 New radiographic vertebral fractures.$

Analysis 5.2

Comparison 5 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 2 New radiographic vertebral fractures.

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Analysis 5.3

Comparison 5 Safety: Vertebroplasty versus placebo (sham) or usual care, Outcome 3 Number of serious other adverse events.

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$Comparison 6 Safety: Vertebroplasty versus kyphoplasty, Outcome 1 New clinical vertebral fractures.$

Analysis 6.1

Comparison 6 Safety: Vertebroplasty versus kyphoplasty, Outcome 1 New clinical vertebral fractures.

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$Comparison 6 Safety: Vertebroplasty versus kyphoplasty, Outcome 2 New radiographic vertebral fractures.$

Analysis 6.2

Comparison 6 Safety: Vertebroplasty versus kyphoplasty, Outcome 2 New radiographic vertebral fractures.

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Analysis 6.3

Comparison 6 Safety: Vertebroplasty versus kyphoplasty, Outcome 3 Number of serious other adverse events.

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$Comparison 7 Safety: Vertebroplasty versus facet joint injection, Outcome 1 New radiographic vertebral fractures.$

Analysis 7.1

Comparison 7 Safety: Vertebroplasty versus facet joint injection, Outcome 1 New radiographic vertebral fractures.

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$Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 1 Pain at 1 to 2 weeks.$

Analysis 8.1

Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 1 Pain at 1 to 2 weeks.

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$Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 2 Pain at 1 month.$

Analysis 8.2

Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 2 Pain at 1 month.

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$Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 3 Disability at 1 to 2 weeks.$

Analysis 8.3

Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 3 Disability at 1 to 2 weeks.

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$Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 4 Disability at 1 month.$

Analysis 8.4

Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 4 Disability at 1 month.

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$Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 5 Quality of life (EQ‐5D) at 1 month.$

Analysis 8.5

Comparison 8 Subgroup analysis: 'Acute' fractures versus 'subacute' fractures, Outcome 5 Quality of life (EQ‐5D) at 1 month.

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Analysis 9.1

Comparison 9 Sensitivity analysis, Outcome 1 Pain at 1 to 2 weeks (0 or 1 to 10 point scale).

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Analysis 9.2

Comparison 9 Sensitivity analysis, Outcome 2 Pain at 1 month (0 or 1 to 10 point scale).

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Analysis 9.3

Comparison 9 Sensitivity analysis, Outcome 3 Pain at 3 months (0 or 1 to 10 point scale).

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Analysis 9.4

Comparison 9 Sensitivity analysis, Outcome 4 Disability at 1 to 2 weeks (RMDQ [0 to 24] or ODI [0 to 100])).

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Analysis 9.5

Comparison 9 Sensitivity analysis, Outcome 5 Disability at 1 month (RMDQ [0 to 24] or ODI [0 to 100]).

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Analysis 9.6

Comparison 9 Sensitivity analysis, Outcome 6 Disability at 3 months (RMDQ [0 to 24] or ODI [0 to 100]).

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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, various countries including Australia, USA, UK, Canada, several European countries, Iran, China, Taiwan Intervention: vertebroplasty versus placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo¹	Vertebroplasty
Pain Scale from: 0 to 10, 0 is no pain. 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 (0.3 better to 1.2 better)		535 (5 studies)	⊕⊕⊕⊕ high²	Absolute change 7% better (3% better to 12% better); relative change 10% better (4% better to 17% better)³
Disability (Roland‐Morris Disability Questionnaire) Scale from: 0 to 23; 0 is no disability. Follow‐up: 1 month	The mean disability in the control groups was 14.2 points	The mean disability in the intervention groups was 1.5 points better (0.4 better to 2.6 better)		472 (4 studies)	⊕⊕⊕⊕ high²	Absolute change 7% better (2% better to 11% better); relative change 9% better (2% better to 15% better)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 62 points	The mean quality of life in the intervention groups was 2.33 points better (1.41 worse to 6.06 better)		351 (3 studies)	⊕⊕⊕⊕ high²	Absolute change 2% better (1% worse to 6% better); relative change 4% better (2% worse to 10% better)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 0.38 points	The mean quality of life in the intervention groups was 0.05 points better (0.01 better to 0.09 better)		285 (3 studies)	⊕⊕⊕⊝ moderate⁴	Absolute change 5% better (1% better to 9% better); relative change 18% improvement (4% better to 32% better)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)	⊕⊕⊕⊝ moderate⁴	Absolute difference 9% more reported success (11% fewer to 29% more); relative change 40% more reported success (33% fewer to 195% more)
Incident symptomatic vertebral fractures Follow‐up: 12 ‐24 months	73 per 1000	95 per 1000 (34 to 264)	RR 1.29 (0.46 to 3.62)	840 (6 studies)⁵	⊕⊕⊝⊝ low^4,6	Absolute difference 3% more fractures with vertebroplasty (8% fewer to 13% more); relative difference 29% more (54% fewer to 262% more)
Other serious adverse events Follow‐up: 12‐24 months	56 per 1000	34 per 1000 (18 to 62)	RR 0.61 (0.33 to 1.10)	821 (5 studies)⁵	⊕⊕⊝⊝ low^4,6	Absolute difference 1% fewer events with vertebroplasty (6% fewer to 4% more); relative change 39% fewer (67% fewer to 10% more)
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; SMD: Standardised mean difference; 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.
¹ For incident vertebral fractures the comparison includes two placebo (sham)‐controlled trials and three trials that compared vertebroplasty versus usual care. ² The internal validity of the five placebo‐controlled trials that have full or some results available is high. Four trials have published their results in peer‐reviewed journals (Buchbinder 2009; Clark 2016; Firanescu 2018; Kallmes 2009) while a fifth trial (VOPE 2015), completed in April 2014, was published as a thesis (http://www.forskningsdatabasen.dk/en/catalog/2371744560), and reported at a conference. Therefore we did not downgrade the evidence due to suspected publication bias although the results of one additional placebo‐controlled trial (VERTOS V) remain unpublished. This trial was previously reported as completed in June 2015, but its status has been changed to 'enrolling by invitation', at: https://clinicaltrials.gov/ct2/show/NCT01963039. While publication bias is possible, it is unlikely the conclusions will change when data from this trial become available. 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 the 0 to 10 pain scale; 2 to 3 points on the 0 to 23 point RMDQ 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 for dichotomous outcomes the total number of participants was small, or number of events was small (<200); or data were from a single trial only ⁵ Pooled both placebo and usual care comparisons in the safety analyses. ⁶ Downgraded due to the possibility of detection bias in the studies with a usual care control group.

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

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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 8 January 2018	Planned sample size	Final sample size
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
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
NCT01677806	Sun G China	Usual care	Age ≥ 50 years Fracture < 6 weeks	23 Aug 2012	Oct 2012	Recruitment status unknown (last updated 11 Sep 2014)	114	‐
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 the Netherlands	Sham	Age ≥ 50 years Fracture ≥ 12 weeks	28 Aug 2013	May 2013	Previously reported as completed (Nov 2015) then recruiting again (Feb 2017) (protocol published)	94	‐
Record of trial registration not found	Chen JP China	Usual care	Not available	Trial registration not found	Unknown	Completed; study awaiting translation	Unknown	84
Record of trial registration not found	Li DH China	Kyphoplasty Bone filling mesh container	Not available	Trial registration not found	Unknown	Completed; study awaiting translation	Unknown	90
Record of trial registration not found	Tan B China	Kyphoplasty	Not available	Trial registration not found	Unknown	Completed; study awaiting translation	Unknown	106
Record of trial registration not found	Zhou W China	Kyphoplasty	Not available	Trial registration not found	Unknown	Completed; study awaiting translation	Unknown	80
* Abstract reported that analysis favoured vertebroplasty at 1 day and 1 week for pain, and disability measured by RMDQ and ODI (data not provided), but no evidence of important differences between groups 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.

Table 1. Study characteristics of unpublished, ongoing and suspended or terminated trials

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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)
Clark 2016	Australia	Vertebroplasty	80	2.8 weeks	8.1 (1.8)	19.5 (3.5)	65.4 (11.4)	Interventional radiologists	7.5 (4.7 ‐ 10.3)	3 days, 14 days, 1, 3 and 6 months
		Placebo	81	2.4 weeks	8.2 (1.5)	19.8 (3.7)	67.7 (11.2)
Chen 2014a	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	‐¤	˜7.6^µ	‐	‐	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	‐¤	˜7.6^µ	‐	‐	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)
Evans 2015	USA	Vertebroplasty	76.1	‐	7.9 (2.0)	16.3 (7.4)	‐	Not reported	Not reported	3 days, 1, 6 and 12 months
		Kyphoplasty	75.1	‐	7.4 (1.9)	17.3 (6.6)	‐	Not reported	Not reported
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)	‐	‐
Firanescu 2018	the Netherlands	Vertebroplasty	74.7	29.2 days	7.7 (1.4)	18 (4.5)	68.4 (17.1)	Interventional radiologists	5.11 (1 ‐ 11)	1 day, 1 week, 1, 3, 6, 12 months
		Placebo	76.8	25.9 days	7.9 (1.6)	17.8 (4.7)	69.7 (17.9)
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	the 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)
Leali 2016	Italy	Vertebroplasty	‐	‐^§	4.8 (‐)	53.6 (‐)	‐	Not reported	4 (‐)	1 and 2 days, 6 weeks, 3 and 6 months
		Usual care	‐	‐^§	‐^§	‐	‐	Not reported
Liu 2010	Taiwan	Vertebroplasty	74.3	15.8 days	7.9 (0.7)	‐	‐	Not reported	4.9 (0.7)	3 days, 6 months, 1, 3 and 5 years
		Balloon kyphoplasty	72.3	17.0 days	8.0 (0.8)	‐	‐	Not reported	5.6 (0.6)
Rousing 2009	Denmark	Vertebroplasty	80	8.4 days	7.5 (2.0)	‐	‐	Orthopaedic surgeons	Not reported	3 months
		Usual care and brace	80	6.7 days	8.8 (1.2)	‐	‐
Sun 2016	China	Vertebroplasty	65.4	‐	8.5 (1.1)	70.6 (8.6)^×	‐	Not reported	3.4 (0.3)	2 days, 12 months
		Kyphoplasty	65.2	‐	8.2 (0.9)	71.7(8.5)^×	‐	Not reported	4.2 (0.2)
Vogl 2013	Germany and USA	Vertebroplasty	74	‐^¥	8.5 (1.2)	‐	‐	Not reported	4.0 (1.1)	1 day, 3 and 12 months
		Shield kyphoplasty	80	‐^¥	8.3 (1.1)	‐	‐	Not reported	3.8 (0.7)
Voormolen 2007	the 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)
VOPE 2015	Denmark	Vertebroplasty	70.6	‐ª	7.47 ()	‐	‐	Orthopaedic surgeons	Not reported^˜	6 hours, weekly to 3 months, 12 months
		Placebo (lidocaine injected)	69.3	‐ª	7.61 ()	‐	‐	Orthopaedic surgeons
Wang 2015	China	Vertebroplasty	69.43	‐	8.1 (1.2)	71.22 (10.56)^×	‐	Not reported	3.31 (0.77)	1 day, 3 and 12 months
		Balloon kyphoplasty	68.63	‐	8.0 (1.1)	71.30 (10.22)^×	‐	Not reported	4.22 (1.29)
Wang 2016	China	Vertebroplasty	63.7	‐ª	7.65 (1.11)	18.3 (1.0)	‐	Spine surgeon	5.5 (3.0 ‐ 9.0)
		Facet joint injection	62.6	‐ª	7.76 (1.06)	18.45 (0.98)	‐	Spine surgeon
Yang 2016	China	Vertebroplasty	77.1	Not reported	7.5 (1.1)	80.2 (9.9)^×	78.1 (8.1)	Not stated	4.5 (3‐6.5)	1 week, 3, 6 and 12 months
		Usual care	76.2	Not reported	7.7 (1.1)	81.5 (9.7)^×	77.5 (8.6)
^$1‐10 point scale used by Farrokhi 2011, 0 to 100 scale used by VOPE 2015 and we report pain with forward bending for this trial as overall pain not reported and have converted SE to SD; ⁺RMDQ: Roland‐Morris Disability Questionnaire; ^†modified RMDQ (0‐23 scale) used by Buchbinder 2009, Kallmes 2009 and Firanescu 2018; ^×Oswestry Disability Index (0 to 100) used by Leali 2016, Wang 2015, Yang 2016; ^ 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; ªNot reported but symptom duration 8 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; ^˜up to 2 mL.

Table 2. Baseline demographic and clinical characteristics of the trial participants

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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	5		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 1 to 2 weeks	5	539	Mean Difference (IV, Random, 95% CI)	‐0.25 [‐0.82, 0.33]
1.2 1 month	5	535	Mean Difference (IV, Random, 95% CI)	‐0.73 [‐1.18, ‐0.28]
1.3 3 months	4	395	Mean Difference (IV, Random, 95% CI)	‐0.48 [‐1.01, 0.05]
1.4 6 months	3	338	Mean Difference (IV, Random, 95% CI)	‐0.59 [‐1.18, 0.01]
1.5 12 months	3	265	Mean Difference (IV, Random, 95% CI)	‐0.42 [‐1.02, 0.18]
1.6 24 months	1	57	Mean Difference (IV, Random, 95% CI)	‐1.1 [‐2.68, 0.48]
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 Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 1 to 2 weeks	2	198	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.78, 2.60]
2.2 1 month	3	326	Risk Ratio (M‐H, Random, 95% CI)	1.53 [0.99, 2.36]
2.3 3 months	2	198	Risk Ratio (M‐H, Random, 95% CI)	1.60 [1.12, 2.30]
2.4 6 months	2	198	Risk Ratio (M‐H, Random, 95% CI)	1.38 [1.02, 1.87]
2.5 12 months	2	230	Risk Ratio (M‐H, Random, 95% CI)	1.29 [1.06, 1.58]
2.6 24 months	1	78	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.84, 2.42]
3 Disability (RMDQ) Show forest plot	4		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 1 to 2 weeks	4	475	Mean Difference (IV, Random, 95% CI)	0.21 [‐1.23, 1.65]
3.2 1 month	4	472	Mean Difference (IV, Random, 95% CI)	‐1.50 [‐2.61, ‐0.38]
3.3 3 months	3	333	Mean Difference (IV, Random, 95% CI)	‐0.81 [‐3.15, 1.52]
3.4 6 months	3	324	Mean Difference (IV, Random, 95% CI)	‐1.82 [‐4.12, 0.47]
3.5 12 months	2	200	Mean Difference (IV, Random, 95% CI)	0.12 [‐1.56, 1.80]
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	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

4.1 1 to 2 weeks	3	352	Mean Difference (IV, Random, 95% CI)	‐3.10 [‐6.96, 0.75]
4.2 1 month	3	351	Mean Difference (IV, Random, 95% CI)	‐2.33 [‐6.06, 1.41]
4.3 3 months	2	244	Mean Difference (IV, Random, 95% CI)	‐0.42 [‐4.23, 3.39]
4.4 6 months	3	330	Mean Difference (IV, Random, 95% CI)	‐1.88 [‐6.66, 2.91]
4.5 12 months	2	219	Mean Difference (IV, Random, 95% CI)	‐1.32 [‐5.41, 2.77]
4.6 24 months	1	57	Mean Difference (IV, Random, 95% CI)	1.30 [‐5.48, 8.08]
5 Treatment success Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

5.1 1 week	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.2 1 month	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.3 3 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.4 6 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.5 12 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.6 24 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6 Quality of Life (EQ5D) Show forest plot	4		Mean Difference (IV, Random, 95% CI)	Subtotals only

6.1 1 to 2 weeks	2	164	Mean Difference (IV, Random, 95% CI)	0.01 [‐0.03, 0.05]
6.2 1 month	3	285	Mean Difference (IV, Random, 95% CI)	0.05 [0.01, 0.09]
6.3 3 months	3	203	Mean Difference (IV, Random, 95% CI)	0.04 [‐0.00, 0.08]
6.4 6 months	2	156	Mean Difference (IV, Random, 95% CI)	0.06 [0.01, 0.10]
6.5 12 months	2	93	Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.17, 0.07]
6.6 24 months	1	44	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.24, 0.24]

Comparison 1. Efficacy: Vertebroplasty versus placebo (sham)

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

1.1 1 to 2 weeks	6	627	Std. Mean Difference (IV, Random, 95% CI)	‐1.33 [‐2.26, ‐0.39]
1.2 1 month	3	384	Std. Mean Difference (IV, Random, 95% CI)	‐2.06 [‐3.35, ‐0.76]
1.3 2 to 3 months	6	627	Std. Mean Difference (IV, Random, 95% CI)	‐1.18 [‐1.95, ‐0.40]
1.4 6 months	5	573	Std. Mean Difference (IV, Random, 95% CI)	‐1.05 [‐1.82, ‐0.28]
1.5 12 months	6	612	Std. Mean Difference (IV, Random, 95% CI)	‐1.02 [‐1.74, ‐0.30]
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	5	494	Std. Mean Difference (IV, Random, 95% CI)	‐2.06 [‐3.28, ‐0.83]
2.2 1 month	3	378	Std. Mean Difference (IV, Random, 95% CI)	‐1.52 [‐3.00, ‐0.04]
2.3 3 months	4	460	Std. Mean Difference (IV, Random, 95% CI)	‐2.76 [‐4.65, ‐0.87]
2.4 6 months	4	461	Std. Mean Difference (IV, Random, 95% CI)	‐1.84 [‐3.37, ‐0.30]
2.5 12 months	4	455	Std. Mean Difference (IV, Random, 95% CI)	‐1.59 [‐2.79, ‐0.38]
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	4		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 1 to 2 weeks	4	448	Mean Difference (IV, Random, 95% CI)	‐5.67 [‐11.65, 0.32]
3.2 1 month	2	289	Mean Difference (IV, Random, 95% CI)	‐10.18 [‐21.49, 1.13]
3.3 2 to 3 months	3	415	Mean Difference (IV, Random, 95% CI)	‐5.83 [‐15.41, 3.75]
3.4 6 months	3	415	Mean Difference (IV, Random, 95% CI)	‐5.14 [‐15.02, 4.74]
3.5 12 months	3	415	Mean Difference (IV, Random, 95% CI)	‐3.40 [‐9.90, 3.11]
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]
5 Treatment success Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

5.1 12 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Efficacy: Vertebroplasty versus usual care (open label)

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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	6		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 1 to 2 weeks	2	462	Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.37, 0.25]
1.2 1 month	2	441	Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.59, 0.48]
1.3 3 months	2	419	Mean Difference (IV, Random, 95% CI)	0.14 [‐0.11, 0.39]
1.4 6 months	3	230	Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.31, 0.22]
1.5 12 months	4	558	Mean Difference (IV, Random, 95% CI)	0.16 [‐0.07, 0.40]
1.6 24 months	2	320	Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.56, 0.27]
2 Disability (ODI) Show forest plot	4	1758	Std. Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.12, 0.07]

2.1 1 to 2 weeks	1	98	Std. Mean Difference (IV, Random, 95% CI)	0.02 [‐0.38, 0.41]
2.2 1 month	2	425	Std. Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.30, 0.08]
2.3 3 months	2	399	Std. Mean Difference (IV, Random, 95% CI)	0.04 [‐0.16, 0.24]
2.4 6 months	1	93	Std. Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.46, 0.35]
2.5 12 months	4	542	Std. Mean Difference (IV, Random, 95% CI)	0.00 [‐0.16, 0.17]
2.6 24 months	1	201	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.35, 0.21]
3 Quality of Life (EQ5D) Show forest plot	2	1346	Std. Mean Difference (IV, Random, 95% CI)	0.06 [‐0.04, 0.17]

3.1 1 month	2	422	Std. Mean Difference (IV, Random, 95% CI)	0.10 [‐0.09, 0.29]
3.2 3 months	1	292	Std. Mean Difference (IV, Random, 95% CI)	0.0 [‐0.23, 0.23]
3.3 6 months	1	88	Std. Mean Difference (IV, Random, 95% CI)	0.03 [‐0.39, 0.45]
3.4 12 months	2	342	Std. Mean Difference (IV, Random, 95% CI)	0.06 [‐0.15, 0.27]
3.5 24 months	1	202	Std. Mean Difference (IV, Random, 95% CI)	0.10 [‐0.18, 0.37]

Comparison 3. Efficacy: Vertebroplasty versus kyphoplasty (balloon)

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Comparison 4. Efficacy: Vertebroplasty versus facet joint injection

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain (0 to 10 point scale) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

1.1 1 to 2 weeks	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 1 month	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
1.3 3 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
1.4 6 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
1.5 12 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2 Disability (RMDQ) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

2.1 1 to 2 weeks	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 1 month	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 3 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.4 6 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.5 12 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3 Quality of Life (SF‐36) 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 6 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
3.4 12 months	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Efficacy: Vertebroplasty versus facet joint injection

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Comparison 5. 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	6	840	Risk Ratio (M‐H, Random, 95% CI)	1.29 [0.46, 3.62]

2 New radiographic vertebral fractures Show forest plot	8	804	Risk Ratio (M‐H, Random, 95% CI)	1.14 [0.71, 1.84]

3 Number of serious other adverse events Show forest plot	5	821	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.33, 1.10]

Comparison 5. Safety: Vertebroplasty versus placebo (sham) or usual care

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Comparison 6. 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	2	593	Risk Ratio (M‐H, Random, 95% CI)	1.18 [0.97, 1.43]

2.1 12 months	2	372	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.21, 3.16]
2.2 24 months	1	221	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.92, 1.51]
3 Number of serious other adverse events Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 12 months	1	101	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.01, 4.14]
3.2 24 months	1	221	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.42, 1.97]

Comparison 6. Safety: Vertebroplasty versus kyphoplasty

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Comparison 7. Safety: Vertebroplasty versus facet joint injection

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 New radiographic vertebral fractures Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 12 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 7. Safety: Vertebroplasty versus facet joint injection

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Comparison 8. Subgroup analysis: 'Acute' fractures versus 'subacute' fractures

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain at 1 to 2 weeks Show forest plot	5		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 'Acute' fractures	5	378	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.38, 0.14]
1.2 'Subacute' fractures	2	157	Std. Mean Difference (IV, Random, 95% CI)	0.01 [‐0.30, 0.33]
2 Pain at 1 month Show forest plot	5	535	Std. Mean Difference (IV, Random, 95% CI)	‐0.27 [‐0.44, ‐0.10]

2.1 'Acute' fractures	5	378	Std. Mean Difference (IV, Random, 95% CI)	‐0.26 [‐0.46, ‐0.05]
2.2 'Subacute' fractures	2	157	Std. Mean Difference (IV, Random, 95% CI)	‐0.29 [‐0.61, 0.02]
3 Disability at 1 to 2 weeks Show forest plot	4	467	Std. Mean Difference (IV, Random, 95% CI)	0.02 [‐0.16, 0.20]

3.1 'Acute' fractures	4	326	Std. Mean Difference (IV, Random, 95% CI)	‐0.03 [‐0.29, 0.22]
3.2 'Subacute' fractures	2	141	Std. Mean Difference (IV, Random, 95% CI)	0.13 [‐0.20, 0.46]
4 Disability at 1 month Show forest plot	4		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only

4.1 'Acute' fractures	4	326	Std. Mean Difference (IV, Random, 95% CI)	‐0.25 [‐0.47, ‐0.04]
4.2 'Subacute' fractures	2	142	Std. Mean Difference (IV, Random, 95% CI)	‐0.14 [‐0.47, 0.19]
5 Quality of life (EQ‐5D) at 1 month Show forest plot	3	281	Mean Difference (IV, Random, 95% CI)	0.05 [0.01, 0.08]

5.1 'Acute' fractures	3	139	Mean Difference (IV, Random, 95% CI)	0.05 [0.01, 0.09]
5.2 'Subacute' fractures	2	142	Mean Difference (IV, Random, 95% CI)	0.04 [‐0.02, 0.10]

Comparison 8. Subgroup analysis: 'Acute' fractures versus 'subacute' fractures

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Comparison 9. Sensitivity analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain at 1 to 2 weeks (0 or 1 to 10 point scale) Show forest plot	11	1166	Std. Mean Difference (IV, Random, 95% CI)	‐0.76 [‐1.30, ‐0.22]

1.1 Sham (placebo) control	5	539	Std. Mean Difference (IV, Random, 95% CI)	‐0.09 [‐0.30, 0.12]
1.2 Usual care (open label) control	6	627	Std. Mean Difference (IV, Random, 95% CI)	‐1.33 [‐2.26, ‐0.39]
2 Pain at 1 month (0 or 1 to 10 point scale) Show forest plot	8	919	Std. Mean Difference (IV, Random, 95% CI)	‐0.94 [‐1.55, ‐0.34]

2.1 Sham (placebo) control	5	535	Std. Mean Difference (IV, Random, 95% CI)	‐0.27 [‐0.44, ‐0.10]
2.2 Usual care (open label) control	3	384	Std. Mean Difference (IV, Random, 95% CI)	‐2.06 [‐3.35, ‐0.76]
3 Pain at 3 months (0 or 1 to 10 point scale) Show forest plot	10	1021	Std. Mean Difference (IV, Random, 95% CI)	‐0.78 [‐1.28, ‐0.29]

3.1 Sham (placebo) control	4	394	Std. Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.40, ‐0.00]
3.2 Usual care (open label) control	6	627	Std. Mean Difference (IV, Random, 95% CI)	‐1.18 [‐1.95, ‐0.40]
4 Disability at 1 to 2 weeks (RMDQ [0 to 24] or ODI [0 to 100])) Show forest plot	8	793	Std. Mean Difference (IV, Random, 95% CI)	‐1.25 [‐2.06, ‐0.43]

4.1 Sham (placebo) control	3	299	Std. Mean Difference (IV, Random, 95% CI)	‐0.00 [‐0.34, 0.34]
4.2 Usual care (open label) control	5	494	Std. Mean Difference (IV, Random, 95% CI)	‐2.06 [‐3.28, ‐0.83]
5 Disability at 1 month (RMDQ [0 to 24] or ODI [0 to 100]) Show forest plot	6	674	Std. Mean Difference (IV, Random, 95% CI)	‐0.88 [‐1.60, ‐0.17]

5.1 Sham (placebo) control	3	296	Std. Mean Difference (IV, Random, 95% CI)	‐0.27 [‐0.50, ‐0.04]
5.2 Usual care (open label) control	3	378	Std. Mean Difference (IV, Random, 95% CI)	‐1.52 [‐3.00, ‐0.04]
6 Disability at 3 months (RMDQ [0 to 24] or ODI [0 to 100]) Show forest plot	6	622	Std. Mean Difference (IV, Random, 95% CI)	‐1.85 [‐3.08, ‐0.61]

6.1 Sham (placebo) control	2	162	Std. Mean Difference (IV, Random, 95% CI)	‐0.11 [‐0.78, 0.55]
6.2 Usual care (open label) control	4	460	Std. Mean Difference (IV, Random, 95% CI)	‐2.76 [‐4.65, ‐0.87]

Comparison 9. Sensitivity analysis

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