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

C.E. Firanescu, J. de Vries, P. Lodder, A. Venmans, M.C. Schoemaker, A.J. Smeets, E. Donga, J.R. Juttmann, C.A.H. Klazen, O.E.H. Elgersma, F.H. Jansen, A.V. Tielbeek, I. Boukrab, K. Schonenberg, W.J.J. van Rooij, J.A. Hirsch, P.N.M. Lohle

Research output: Contribution to journalArticleScientificpeer-review

6 Downloads (Pure)

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 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.

Results
The 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.

Conclusions
Percutaneous 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.
Original languageEnglish
Article numberk1551
Number of pages9
JournalBMJ, British Medical Journal
Volume361
Issue number361
DOIs
Publication statusPublished - 2018

Fingerprint

Lidocaine
Cementation
Community Hospital
Netherlands
Confidence Intervals
Surveys and Questionnaires

Keywords

  • Aged
  • Aged, 80 and over
  • Back Pain/physiopathology
  • Bone Cements/therapeutic use
  • Disability Evaluation
  • Double-Blind Method
  • Female
  • Fractures, Compression/physiopathology
  • Humans
  • Male
  • Osteoporotic Fractures/physiopathology
  • Outcome Assessment (Health Care)
  • Pain Measurement
  • Postoperative Complications
  • Spinal Fractures/physiopathology
  • Vertebroplasty

Cite this

Firanescu, C.E. ; de Vries, J. ; Lodder, P. ; Venmans, A. ; Schoemaker, M.C. ; Smeets, A.J. ; Donga, E. ; Juttmann, J.R. ; Klazen, C.A.H. ; Elgersma, O.E.H. ; Jansen, F.H. ; Tielbeek, A.V. ; Boukrab, I. ; Schonenberg, K. ; van Rooij, W.J.J. ; Hirsch, J.A. ; Lohle, P.N.M. / Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV) : Randomised sham controlled clinical trial. In: BMJ, British Medical Journal. 2018 ; Vol. 361, No. 361.
@article{e840fbec110d4493b03dcee88ea45bfe,
title = "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.",
keywords = "Aged, Aged, 80 and over, Back Pain/physiopathology, Bone Cements/therapeutic use, Disability Evaluation, Double-Blind Method, Female, Fractures, Compression/physiopathology, Humans, Male, Osteoporotic Fractures/physiopathology, Outcome Assessment (Health Care), Pain Measurement, Postoperative Complications, Spinal Fractures/physiopathology, Vertebroplasty",
author = "C.E. Firanescu and {de Vries}, J. and P. Lodder and A. Venmans and M.C. Schoemaker and A.J. Smeets and E. Donga and J.R. Juttmann and C.A.H. Klazen and O.E.H. Elgersma and F.H. Jansen and A.V. Tielbeek and I. Boukrab and K. Schonenberg and {van Rooij}, W.J.J. and J.A. Hirsch and P.N.M. Lohle",
year = "2018",
doi = "10.1136/bmj.k1551",
language = "English",
volume = "361",
journal = "BMJ, British Medical Journal",
issn = "0959-8138",
publisher = "BRITISH MED JOURNAL PUBL GROUP",
number = "361",

}

Firanescu, CE, de Vries, J, Lodder, P, Venmans, A, Schoemaker, MC, Smeets, AJ, Donga, E, Juttmann, JR, Klazen, CAH, Elgersma, OEH, Jansen, FH, Tielbeek, AV, Boukrab, I, Schonenberg, K, van Rooij, WJJ, Hirsch, JA & Lohle, PNM 2018, 'Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): Randomised sham controlled clinical trial', BMJ, British Medical Journal, vol. 361, no. 361, k1551. https://doi.org/10.1136/bmj.k1551

Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV) : Randomised sham controlled clinical trial. / Firanescu, C.E.; de Vries, J.; Lodder, P.; Venmans, A.; Schoemaker, M.C.; Smeets, A.J.; Donga, E.; Juttmann, J.R.; Klazen, C.A.H.; Elgersma, O.E.H.; Jansen, F.H.; Tielbeek, A.V.; Boukrab, I.; Schonenberg, K.; van Rooij, W.J.J.; Hirsch, J.A.; Lohle, P.N.M.

In: BMJ, British Medical Journal, Vol. 361, No. 361, k1551, 2018.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV)

T2 - Randomised sham controlled clinical trial

AU - Firanescu, C.E.

AU - de Vries, J.

AU - Lodder, P.

AU - Venmans, A.

AU - Schoemaker, M.C.

AU - Smeets, A.J.

AU - Donga, E.

AU - Juttmann, J.R.

AU - Klazen, C.A.H.

AU - Elgersma, O.E.H.

AU - Jansen, F.H.

AU - Tielbeek, A.V.

AU - Boukrab, I.

AU - Schonenberg, K.

AU - van Rooij, W.J.J.

AU - Hirsch, J.A.

AU - Lohle, P.N.M.

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Back Pain/physiopathology

KW - Bone Cements/therapeutic use

KW - Disability Evaluation

KW - Double-Blind Method

KW - Female

KW - Fractures, Compression/physiopathology

KW - Humans

KW - Male

KW - Osteoporotic Fractures/physiopathology

KW - Outcome Assessment (Health Care)

KW - Pain Measurement

KW - Postoperative Complications

KW - Spinal Fractures/physiopathology

KW - Vertebroplasty

U2 - 10.1136/bmj.k1551

DO - 10.1136/bmj.k1551

M3 - Article

VL - 361

JO - BMJ, British Medical Journal

JF - BMJ, British Medical Journal

SN - 0959-8138

IS - 361

M1 - k1551

ER -