Vertebroplasty for osteoporotic vertebral compression fractures

Background

Osteoporosis is characterised by thin, fragile bones. Osteoporotic vertebral compression fractures are minimal trauma fractures of the vertebral (spine) bones (vertebrae). They can cause severe pain and disability.

Vertebroplasty involves injecting medical-grade cement into a fractured vertebra through a needle inserted into the skin, under light sedation or general anaesthesia. The cement hardens in the bone space to form an internal cast.

Study characteristics

This Cochrane review is current to November 2014. Studies compared vertebroplasty versus placebo (no cement injected) (two studies, 209 randomised participants); usual care (six studies, 566 randomised participants); and kyphoplasty (similar but before the cement is injected a balloon is expanded in the fractured vertebra; 4 studies, 545 randomised participants). The majority of participants were female, aged between 63.3 and 80 years and symptom duration ranged from a week to > six months. We limit reporting to the main comparison, vertebroplasty versus sham here.

Key results

Compared with a placebo (fake) procedure, people who had vertebroplasty did not differ for the following outcomes at one month:

Pain (lower scores mean less pain):

Improved by 7% (15% better to 1.5% worse), or 0.7 points (1.5 better to 0.15 worse) on a 0 to 10-point scale.

• People who had vertebroplasty rated their pain as 4.3 points.

• People who had a placebo (fake) procedure rated their pain as 5 points.

Disability (lower scores mean less disability):

Improved by 5% (13% better to 3% worse), or 1.1 points (2.9 better to 0.8 worse) on a 0 to 23-point scale.

• People who had vertebroplasty rated their disability as 12.5 points.

• People who had a placebo (fake) procedure rated their pain as 13.6 points.

Vertebral fracture or osteoporosis-specific quality of life (lower scores mean better quality of life):

Worse by 0.4% (5% worse to 5% better), or 0.4 points worse (5.4 worse to 4.6 better) on a 0 to 100-point scale.

.• People who had vertebroplasty rated their quality of life related to their fracture as 2.8 points.

• People who had a placebo (fake) procedure rated their quality of life related to their fracture as 2.4 points.

Overall quality of life (higher scores mean better quality of life):

Improved by 5% (1% worse to 11% better), or 0.05 units (0.01 worse to 0.11 better) on a 0 = death to 1 = perfect health scale.

• People who had vertebroplasty rated their general quality of life as 0.32 points.

• People who had a placebo (fake) procedure rated their general quality of life as 0.27 points.

Treatment success (defined as pain moderately or a great deal better):

9% more people rated their treatment a success (11% fewer to 29% more), or 9 more people out of 100.

• 32 out of 100 people reported treatment success with vertebroplasty.

• 23 out of 100 people reported treatment success with placebo (fake) procedure.

New symptomatic vertebral fractures (at 12 months):

6% more new fractures with vertebroplasty (2% fewer to 14% more), or 6 more people out of 100.

• 20 out of 100 people had a new fracture with vertebroplasty.

• 14 out of 100 people had a new fracture with a placebo (fake) procedure or usual care.

Other serious adverse events:

No more people (4% fewer to 4% more), had serious adverse events with vertebroplasty; relative change 1% more (79% fewer to 385% more).

• 29 out of 100 people reported side effects with vertebroplasty.

• 28 out of 100 people reported side effects with a placebo (fake) procedure.

Quality of the evidence

Moderate-quality evidence shows that vertebroplasty does not provide more clinically important benefits than a placebo (fake) procedure. The quality was downgraded from high to moderate due to the small number of trials and participants. Moderate quality evidence leaves us uncertain about the effect of vertebroplasty on the risk of new vertebral fractures or other serious adverse events compared with placebo. Further research may change these effect estimates.

Serious adverse events that may occur include spinal cord or nerve root compression due to cement leakage, cement emboli into the lungs and large vessels, rib fractures, osteomyelitis, fat embolism, thecal sac injury, anaesthetic complications and death.

Authors' conclusions: 

Based upon moderate quality evidence, our review does not support a role for vertebroplasty for treating osteoporotic vertebral fractures in routine practice. We found no demonstrable clinically important benefits compared with a sham procedure and subgroup analyses indicated that results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.

Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the lack of high quality evidence supporting benefit of vertebroplasty and its potential for harm.

Read the full abstract...
Background: 

Percutaneous vertebroplasty is widely used to treat acute and subacute painful osteoporotic vertebral fractures although recent placebo-controlled trials have questioned its value.

Objectives: 

To synthesise the available evidence regarding the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures.

Search strategy: 

We searched CENTRAL, MEDLINE and EMBASE up to November 2014. We also reviewed reference lists of review articles, trials and trial registries to identify any other potentially relevant trials.

Selection criteria: 

We included randomised and quasi-randomised controlled trials (RCTs) including adults with painful osteoporotic vertebral fractures of any duration and comparing vertebroplasty with placebo (sham), usual care, or any other 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: 

At least two review authors independently selected trials for inclusion, extracted data, performed 'Risk of bias' assessment and assessed the quality of the body of evidence for the main outcomes using GRADE.

Main results: 

Eleven RCTs and one quasi-RCT conducted in various countries were included. Two trials compared vertebroplasty with placebo (209 randomised participants), six compared vertebroplasty with usual care (566 randomised participants) and four compared vertebroplasty with kyphoplasty (545 randomised participants). Trial size varied from 34 to 404 participants, most participants were female, mean age ranged between 63.3 and 80 years, and mean symptom duration varied from a week to more than six months.

Both placebo-controlled trials were judged to be at low overall risk of bias while other included trials were generally considered to be at high risk of bias across a range of criteria, most seriously due to lack of participant and study personnel blinding.

Compared with placebo, there was moderate quality evidence based upon two trials that vertebroplasty provides no demonstrable benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success. At one month, mean pain (on a scale 0 to 10, higher scores indicate more pain) was 5 points with placebo and 0.7 points better (1.5 better to 0.15 worse) with vertebroplasty, an absolute pain reduction of 7% (15% better to 1.5% worse) and relative reduction of 10% (21% better to 2% worse) (two trials, 201 participants). At one month, mean disability measured by the Roland Morris Disability Questionnaire (scale range 0 to 23, higher scores indicate worse disability) was 13.6 points in the placebo group and 1.1 points better (2.9 better to 0.8 worse) in the vertebroplasty group, absolute improvement in disability 4.8% (12.8% better to 3.3% worse), relative change 6.3% better (17.0% better to 4.4% worse) (two trials, 201 participants).

At one month, disease-specific quality of life measured by the QUALEFFO (scale 0 to 100, higher scores indicating worse quality of life) was 2.4 points in the placebo group and 0.40 points worse (4.58 better to 5.38 worse) in the vertebroplasty group, absolute change: 0.4% worse (5% worse to 5% better), relative change 0.7% worse (9% worse to 8% better (based upon one trial, 73 participants). At one month overall quality of life measured by the EQ5D (0 = death to 1 = perfect health, higher scores indicate greater quality of life at one month was 0.27 points in the placebo group and 0.05 points better (0.01 worse to 0.11 better) in the vertebroplasty group, absolute improvement in quality of life 5% (1% worse to 11% better), relative change 18% better (4% worse to 39% better) (two trials, 201 participants). Based upon one trial (78 participants) at one month, 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; range 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute risk difference 9% more reported success (11% fewer to 29% more); relative change 40% more reported success (33% fewer to 195% more).

Based upon moderate quality evidence from three trials (one placebo, two usual care, 281 participants) with up to 12 months follow-up, we are uncertain whether or not vertebroplasty increases the risk of new symptomatic vertebral fractures (28/143 observed in the vertebroplasty group compared with 19/138 in the control group; RR 1.47 (95% CI 0.39 to 5.50).

Similary, based upon moderate quality evidence from two placebo-controlled trials (209 participants), we are uncertain about the exact risk of other adverse events (3/106 were observed in the vertebroplasty group compared with 3/103 in the placebo group; RR 1.01 (95% CI 0.21 to 4.85)). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.

Our subgroup analyses provided limited evidence that the effects did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Including data from the six trials that compared vertebroplasty with usual care in a sensitivity analyses inconsistently altered the primary results, with all combined analyses displaying substantial to considerable heterogeneity.

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