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.
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.
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.
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.
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.