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Background: Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures., Methods: Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466., Findings: Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported., Interpretation: In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost., Funding: ZonMw; COOK Medical., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

The aim of the study was to delineate rates of surgery, length of hospital stay, return to work, iterative surgery rates and cost to society of spinal tumor (ST) and spinal fracture (SF) surgery in Belgium. Overall surgery rates were obtained from the National Institute for Health Care and Disability Insurance. Medical and financial claims data were abstracted from the administrative database of the Alliance of Christian Sickness Funds which includes data of 42% of the mandatory insured Belgian population. All records including the reimbursement codes for ST and SF surgery in 2005 were identified. A logistic regression model was developed to determine the socio-demographic, surgery-related and sick leave predictors of return to work. Our database contained information about 3.791 patients who underwent surgery for SF and 2.322 patients who had surgery for ST. Year-to-year surgery rate growth for SF was estimated at 15%. The yearly increase in surgery rates for ST was calculated at 11%. The return to work rate was 90% 1 year after surgery for both SF and ST. Sixty percent of patients who underwent radiotherapy and surgery for ST were still alive 1 year after surgery. Length of hospital stay ranged from 1 to 27 days after surgery for ST and from 1 to 16 days after surgery for SF. Repeat surgery was performed in 8% of the ST cases and in 12% of the SF patients. Return to work rate remained significantly lower for blue collar workers, self-employed workers and patients with a longer sick leave before surgery. Patients who were absent from work for more than 3 months at time of surgery represent a high-risk group with regard to successful functional recovery.