Percutaneous Vertebroplasty is no Risk Factor for New Vertebral Fractures and Protects Against Further Height Loss (VERTOS IV)
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Percutaneous vertebroplasty (PV) is an alternative option to treat pain after an osteoporotic vertebral compression fracture (OVCF). Controversy exists as to whether PV increases the risk of new OVCFs or prevents further vertebral height loss in treated levels. We assessed both during 1-year follow-up in patients with acute OVCF randomised to PV or a sham procedure.
VERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. New OVCFs and further vertebral height loss were assessed at 3, 6, and 12 months.
After a median follow-up of 12 months (interquartile range (IQR) = 12–12) 31 new fractures were reported in 15 patients from the PV group and 28 new fractures in 19 patients from the sham group. The occurrence of new vertebral fractures did not significantly differ between the groups (χ2(1) = 0.83, p = 0.36, OR = .71, 95%CI = 0.33–1.50). There was no higher fracture risk of adjacent versus distant vertebrae. After sham procedure, further height loss of treated vertebrae occurred more frequently (7 patients (8%) in the PV group and 39 (45%) in the sham group (χ2(1) = 28.85, p < 0.001, OR = 9.84, 95%CI = 4.08–23.73)) and was more severe (p < .001) than after PV.
The risk of further vertebral height loss is significantly lower after PV compared to a sham intervention, i.e. PV protects against progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs.
Level of Evidence
Level 1a, therapeutic study.
ClinicalTrials.gov number, NCT01200277
KeywordsOsteoporotic percutaneous vertebroplasty (PV) Vertebral compression fracture (OVCF) Visual analogue scale (VAS) Polymethylmethacrylate (PMMA) VERTOS IV Randomised controlled trial (RCT)
CEF and PNML had full access to all the data in the study, take responsibility for the integrity of the data and the accuracy of the data analysis, and act as guarantors. PNML, CAHK, JdV, MCS, AJS, JRJ, ED, OEHE, and FHJ designed the study. IVDH, MB, and KS gathered the data. PNML, MCS, AJS, CAHK, OEHE, and FHJ performed the procedures. PL and JdV analysed the data. CEF and AV undertook morphometric measurements. CEF, PNML, AV, JdV, and PL wrote the first draft, and all the contributors made the decision to submit the manuscript for publication.
This study was supported by Stryker (Grant No. S-I-013). The sponsor had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
Compliance with Ethical Standards
Conflict of interests
The authors declare that they have no competing interest.
Ethics Approval and Consent to Participate
The procedures were in accordance with the ethical standards of the institutional research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. This trial was an institutional review board-approved sham-controlled, double-blind, multicentre, randomised trial performed at four community hospitals in the Netherlands (MN-11-004, approval protocol 1055).
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