• Spine · Jun 2009

    Randomized Controlled Trial Comparative Study

    Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study.

    • Rikke Rousing, Mikkel O Andersen, Stig M Jespersen, Karsten Thomsen, and Jens Lauritsen.
    • Department of Orthopaedics, University Hospital of Odense, Odense, Denmark. rikke.rousing@ouh.regionsyddanmark.dk
    • Spine. 2009 Jun 1; 34 (13): 1349-54.

    Study DesignClinical randomized study.ObjectiveThe 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 DataPVP 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.MethodsFifty 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.ResultsReduction 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.ConclusionThe 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.

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