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.