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| 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 [with consumer summary] |
| Rousing R, Andersen MO, Jespersen SM, Thomsen K, Lauritsen J |
| Spine 2009 Jun 1;34(13):1349-1354 |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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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.
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