Dataset Information

Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis.

ABSTRACT:

Objective

To determine whether vertebroplasty is more effective than placebo for patients with pain of recent onset (≤ 6 weeks) or severe pain (score ≥ 8 on 0-10 numerical rating scale).

Design

Meta-analysis of combined individual patient level data.

Setting

Two multicentred randomised controlled trials of vertebroplasty; one based in Australia, the other in the United States.

Participants

209 participants (Australian trial n = 78, US trial n = 131) with at least one radiographically confirmed vertebral compression fracture. 57 (27%) participants had pain of recent onset (vertebroplasty n = 25, placebo n = 32) and 99 (47%) had severe pain at baseline (vertebroplasty n = 50, placebo n = 49).

Intervention

Percutaneous vertebroplasty versus a placebo procedure.

Main outcome measure

Scores for pain (0-10 scale) and function (modified, 23 item Roland-Morris disability questionnaire) at one month.

Results

For participants with pain of recent onset, between group differences in mean change scores at one month for pain and disability were 0.1 (95% confidence interval -1.4 to 1.6) and 0.2 (-3.0 to 3.4), respectively. For participants with severe pain at baseline, between group differences for pain and disability scores at one month were 0.3 (-0.8 to 1.5) and 1.4 (-1.2 to 3.9), respectively. At one month those in the vertebroplasty group were more likely to be using opioids.

Conclusions

Individual patient data meta-analysis from two blinded trials of vertebroplasty, powered for subgroup analyses, failed to show an advantage of vertebroplasty over placebo for participants with recent onset fracture or severe pain. These results do not support the hypothesis that selected subgroups would benefit from vertebroplasty.

SUBMITTER: Staples MP

PROVIDER: S-EPMC3133975 | biostudies-literature |

REPOSITORIES: biostudies-literature

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