Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial.

ABSTRACT:

Objective

To assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body.

Design

Randomised, double blind, sham controlled clinical trial.

Setting

Four community hospitals in the Netherlands, 2011-15.

Participants

180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).

Interventions

Participants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group.

Main outcome measures

Main outcome measure was mea

SUBMITTER: Firanescu CE 

PROVIDER: S-EPMC5941218 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature