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

Abstract

ObjectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body.DesignRandomised, double blind, sham controlled clinical trial.SettingFour community hospitals in the Netherlands, 2011-15.Participants180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).InterventionsParticipants 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 measuresMain outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months’ follow-up.ResultsThe mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval −0.53 to 0.94) at baseline, −0.43 (−1.17 to 0.31) at one day, −0.11 (−0.85 to 0.63) at one week, 0.41 (−0.33 to 1.15) at one month, 0.21 (−0.54 to 0.96) at three months, 0.39 (−0.37 to 1.15) at six months, and 0.45 (−0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months’ follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction.ConclusionsPercutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months’ follow-up among patients with acute osteoporotic vertebral compression fractures.Trial registrationClinicalTrials.gov NCT01200277.

Why we should stop performing vertebroplasties for osteoporotic spinal fractures

“…Two of the three recent trials observed no clinically important benefits of vertebroplasty over placebo at any time point . While the third trial reported a benefit favouring vertebroplasty for their primary outcome, the proportion of participants achieving an overall pain score of less than 4 at 14 days, differences between groups using the metric of comparison of mean improvement in pain, was smaller than what is generally accepted as clinically relevant at all time points up to 6 months other than 3 days .…”

“…Two of the three recent trials observed no clinically important benefits of vertebroplasty over placebo at any time point. 20,22 While the third trial reported a benefit favouring vertebroplasty for their primary outcome, the proportion of participants achieving an overall pain score of less than 4 at 14 days, differences between groups using the metric of comparison of mean improvement in pain, was smaller than what is generally accepted as clinically relevant at all time points up to 6 months other than 3 days. 21 In addition, there were possible sources of bias including use of a potentially less credible placebo in comparison to previous trials (which may have led to the significant difference in proportion of participants who correctly guessed their treatment allocation at 14 days), and selective reporting of pre-specified outcomes (including failing to report success of blinding at 3 days), that may have led to an overestimation of benefit compared to other placebo-controlled trials.…”

“…To their credit, three more placebo‐controlled trials have now been completed, although one, completed more than 3 years ago, remains unpublished in the peer‐reviewed literature . All three limited inclusion to people with a short duration of symptoms (≤8 weeks, <6 weeks and ≤9 weeks).…”

Vertebroplasty for acute painful osteoporotic vertebral compression fractures: An update

“…VERTOS IV is the most recent double-blinded shamcontrolled RCT to evaluate the safety and efficacy of vertebroplasty in VCFs (n = 180). 15 Patients were recruited via written questionnaires from referrals for spinal radiographs rather than referrals for vertebroplasty. Median duration of back pain prior to vertebroplasty was 6.1 weeks (IQR 4.1-8.7).…”

No more vertebroplasty for acute vertebral compression fractures?

“…Fragility fractures cause deformity as well as pain and seem to be associated with an increased mortality from respiratory disease 8. Importantly, no long term trials have evaluated whether vertebroplasty performed at any stage improves long term outcomes such as deformity and mortality when combined with medical treatment of osteoporosis.…”