Vertebroplasty Versus Sham Intervention for Painful Chronic Osteoporotic Vertebral Compression Fractures (VERTOS 5): Randomised Sham Controlled Clinical Trial

Abstract

Background: There is limited evidence to support the use of percutaneous vertebroplasty (PV) in chronic painful osteoporotic vertebral compression fractures (oVCFs). Methods: We performed a randomised sham-controlled clinical trial in patients with painful oVCFs older than three months with bone edema on magnetic resonance imaging (MRI). Patients were randomly assigned to undergo PV (cementation) or sham intervention (subcutaneous infiltration with 1% lidocaine followed by 0·25% bupivacaine into each pedicle and simulated cement injection). Outcomes were assessed at 1 day, 1 week and at 1, 3, 6 and 12 months. Primary outcome was change of pain on a scale of 0 to 10, with 10 being the maximum imaginable pain. Secondary outcomes were health-related quality of life (QUALEFFO) and physical functioning (RMD). Results: 80 patients were enrolled and randomised: PV (n=40) and sham intervention (n=40). Compared with baseline, the reduction in VAS score during 12 months in both groups was clinically and statistically significant at all measurement points. The mean VAS score at 12 months declined: 3·62 in the PV group (95% confidence interval 2·66 to 4·59) and 2.36 in the sham intervention group (1·42 to 3·31) with a significantly lower VAS score after PV at 12 months than sham intervention (p = 0·022). There was significant more improvement of quality of life (QUALEFFO) after PV compared to sham intervention, with a positive correlation for physical functioning (RMD). Conclusion: PV is superior to sham intervention for pain reduction in patients with chronic oVCFs of more than 3 months’ in duration with better quality of life results. Trial Registration: ClinicalTrials.gov NCT01963039; officially completed September 3, 2020. Funding Statement: Funding provided by Stryker Medical l and Medtronic. Declaration of Interests: None to declare Ethics Approval Statement: The protocol was approved by the institutional review board METC Brabant at the ETZ in the Netherlands and European Union Privacy Rules were followed. The protocol has been published in ClinicalTrials.gov (identifier: NCT01963039) and can be accessed online. All participants gave written informed consent to take part in the trial.