Journal Article

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

Tielbeek, Alexander V, Lodder, Paul, de Vries, Jolanda, van Rooij, Willem Jan J, Juttmann, Job R, Hirsch, Joshua A, Klazen, Caroline A H, Lohle, Paul N M, Boukrab, Issam, Schonenberg, Karen, Firanescu, Cristina E, Jansen, Frits H, Donga, Esther, Elgersma, Otto E H, Schoemaker, Marinus C, Smeet, Albert J, Venmans, Alexander

2018

Overview

AbstractObjectiveTo 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.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group Ltd
• Subject: Aged / Aged, 80 and over / Analgesics / Back pain / Back Pain - physiopathology / Back Pain - surgery / Bone Cements - therapeutic use / Bone surgery / Bupivacaine / Cement / Clinical trials / Compression / Disability Evaluation / Double-Blind Method / Edema / Evidence-based medicine / Female / Fractures / Fractures, Compression - physiopathology / Fractures, Compression - surgery / Humans / Intervention / Lidocaine / Male / Medical imaging / Narcotics / NMR / Nuclear magnetic resonance / Opioids / Osteoporosis / Osteoporotic Fractures - physiopathology / Osteoporotic Fractures - surgery / Outcome Assessment (Health Care) / Pain / Pain Measurement / Patients / Postoperative Complications / Quality of life / Rheumatology / Spinal Fractures - physiopathology / Spinal Fractures - surgery / Statistical analysis / Tomography / Vertebrae / Vertebroplasty