Study Design. Clinical randomized study.
Objective. The aim of this study is to compare percutaneous vertebroplasty (PVP) to conservative treatment of patients with osteoporotic vertebral fractures in a clinical randomized study with respect to pain, physical and mental outcome, and to asses the risk of adjacent fractures.
Summary of Background Data. PVP is a therapeutic procedure performed to reduce pain in vertebral lesions. Despite the lack of comparative randomized clinical trials PVP is generally seen as a safe and efficient procedure for painful osteoporotic fractures.
Methods. Fifty patients (41 females) were included from January 2001 until January 2008. Patients with acute (<2 weeks) and subacute (between 2 and 8 weeks) osteoporotic fractures were included and randomized to either PVP or conservative treatment. Pain was assessed with a visual analogue scale and physical and mental outcome were assessed by validated questionnaires and tests. Tests, questionnaires, and plain radiographs were performed at the inclusion and after 3 months.
Results. Reduction in pain from initial visit to 3-month follow-up was comparable in the 2 groups (P = 0.33) from approximate visual analogue scale 8.0 to visual analogue scale 2.0, intragroup difference was significant (P = 0.00). Reduction in pain in the PVP group was immediate 12 to 24 hours after the procedure (P = 0.00). There was no significant difference in the other parameters when comparing the results at inclusion and after 3 months within both groups and between the groups after 3 months with a few exceptions. We observed 2 adjacent fractures in the PVP group and non in the conservative group.
Conclusion. The majority of patients with acute or subacute painful osteoporotic compression fractures in the spine will recover after a few months of conservative treatment. The risk of adjacent fractures needs further research. No major adverse events were observed.