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.
Patients treated with percutaneous vertebroplasty for osteoporotic vertebral fractures show no better physical and mental outcome at 3-month follow-up compared to conservatively treated patients in this randomized study. The number of patients was too small to asses the risk of fractures in levels adjacent to treated levels.
From the Department of Orthopaedics, University Hospital of Odense, Odense, Denmark.
Acknowledgment date: September 30, 2008. First Revision date: November 27, 2008. Second Revision date: January 6, 2009. Acceptance date: January 8, 2009.
The manuscript submitted does not contain information about medical device(s)/drug(s).
Foundation and Danish government funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Rikke Rousing, MD, Department of Orthopaedics, University Hospital of Odense, Sdr. Boulevard 29, 5000 Odense C, Denmark; E-mail: firstname.lastname@example.org