Abstract
Introduction
Osteoporotic vertebral compression fractures (VCF) affect ~20% of postmenopausal women and can lead to long-term disability. Since two double-blind RCTs in 2009, there has been a debate, whether Percutaneous Vertebroplasty (PVP) has any beneficial effects in treating acute osteoporotic VCFs. The two studies have been criticized in order of design and possible bias in results. PVP is a minimally invasive procedure, primarily used in patients with severe pain after VCF. Our objective was to investigate the clinical effects of PVP compared with a SHAM procedure when treating acute osteoporotic VCFs, with intense focus on VAS-activity and the first 3 months postoperative.
Material and Methods
Study Design - Double-blind randomized controlled trial. 52 patients were included in the study, and they were randomized to either PVP or SHAM, at the Center for Spine Surgery and Research, Middelfart Hospital. During the trial period 4 patients were excluded due to need for further spine surgery, and 2 patients excluded due to malignancy in peroperative biopsy. During the trial patients, investigators collecting data, and the statisticians were blinded.
Results
46 patients were eligible for statistical analysis, 22 patients in the PVP group and 24 patients in the SHAM group. In both groups the VAS-scores, and health related Quality of life scores (SF-36; PCS-score and Eq. 5D-scores) improved significantly from baseline values (p < 0.05). There was a statistical significant higher VAS-score in the SHAM-group throughout the trial period (p = 0.001), with the main contribution from the VAS-activity.
Conclusion
Our study shows a statistical significant higher VAS-score in the SHAM group during the trial period, both groups improved significantly in all clinical parameters. Focus in the future of PVP and acute OVCFs must be on the 3 months convalescence period and the cost benefit analysis of early mobilization.