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Background/Purpose: We previously reported the results of a randomized participant and outcome assessor blinded controlled trial that found no beneficial effect of vertebroplasty (VP) over placebo for people with acute osteoporotic fractures up to 24 months and no between-group differences in incident clinical vertebral fractures. A secondary aim was to determine the effect of VP on the risk of further radiologically apparent vertebral fracture at 12 and 24 months. Method(s): The trial was registered (ACTRN012605000079640), and conducted between April 2004 and October 2010. Eligible participants had one or two acute osteoporotic vertebral compression fractures of at least grade 1, confirmed by history, radiograph and the presence of bone oedema. They were randomly assigned to VP (n=38) or placebo (n=40). Cement volume and leakage were recorded for the VP group during the cement injection and on imaging post-procedure. Plain thoracolumbar radiographs were taken at baseline, 12 and 24 months. Two independent radiologists assessed these for new and progressed fractures at the same, adjacent and non-adjacent levels. Discrepancies were resolved by consensus at the completion of the review process. A total sample of 164 participants (82/group) was needed to show a three-fold increase in the risk of further vertebral fractures at 24 months assuming a 10% event rate in the placebo group. Recruitment difficulties led to trial enrolment being terminated early after reaching sufficient numbers to address the primary efficacy outcomes but insufficient to assess the safety outcomes. Result(s): Baseline characteristics were similar between the two groups (31 females in each group, mean (SD) age, median (interquartile range) duration of symptoms and one or more prior vertebral fractures was 74.2 (14.0), 9.0 (3.8 to 13.0) and 18 (47%) in the VP group, and 78.9 (9.5), 9.5 (3.0 to 17.0) and 21 (52%) in the placebo group). At 12 and 24 months, radiographs were available for 45 (58%) a

Summary: A randomised controlled trial of vertebroplasty (VP) versus placebo assessed the effect of VP on the risk of further vertebral fractures. While no statistically significant between-group differences for new or progressed fracture risk at 12 and 24 months were observed, we observed a consistent trend towards higher risk of any type of fracture in the group undergoing VP. Our analysis was underpowered, and further adequately powered studies are needed to be able to draw firm conclusions about further vertebral risk with vertebroplasty. Purpose(s): This study seeks to assess the effect of VP on the risk of further radiologically apparent vertebral fracture within two years of the procedure. Method(s): We conducted a randomised placebo-controlled trial of VP in people with acute osteoporotic vertebral fracture. Eligible participants were randomly assigned to VP (n = 38) or placebo (n = 40). Cement volume and leakage were recorded for the VP group. Plain thoracolumbar radiographs were taken at baseline, 12 and 24 months. Two independent radiologists assessed these for new and progressed fractures at the same, adjacent and non-adjacent levels. Result(s): At 12 and 24 months, radiographs were available for 45 (58 %) and 47 (60 %) participants, respectively. There were no between-group differences for new or progressed fractures: 32 and 40 in the VP group after 12 and 24 months compared with 21 and 33 in the placebo group (hazard ratio (HR) 1.80, 95 % confidence interval (CI) 0.82 to 3.94). Similar results were seen when considering only adjacent (HR (95 % CI) 2.30 (0.57 to 9.29)) and non-adjacent (HR (95 % CI) 1.45 (0.55 to 3.81) levels. In all comparisons, there was a consistent trend towards higher risk of any type of fracture in the group undergoing VP. Within the VP group, fracture risk was unrelated to total (HR (95 % CI) 0.91 (0.71 to 1.17)) or relative (HR (95 % CI) 1.31 (0.15 to 11.48)) cement volume or cement leakage (HR (95 % CI) 1.20 (0.63 to 2.31)). Co

Objective. The aims of this double-blind, randomized, placebo-controlled trial were to determine whether ultrasound-guided extracorporeal shock wave therapy (ESWT) reduced pain and improved function in patients with lateral epicondylitis (tennis elbow) in the short term and intermediate term. Methods. Sixty-eight patients from community-based referring doctors were randomized to receive 3 ESWT treatments or 3 treatments at a subtherapeutic dose given at weekly intervals. Seven outcome measures relating to pain and function were collected at followup evaluations at 6 weeks, 3 months, and 6 months after completion of the treatment. The mean changes in outcome variables from baseline to 6 weeks, 3 months, and 6 months were compared for the 2 groups. Results. The groups did not differ on demographic or clinical characteristics at baseline and there were significant improvements in almost all outcome measures for both groups over the 6-month followup period, but there were no differences between the groups even after adjusting for duration of symptoms. Conclusion. Our study found little evidence to support the use of ESWT for the treatment of lateral epicondylitis and is in keeping with recent systematic reviews of ESWT for lateral epicondylitis that have drawn similar conclusions. The Journal of Rheumatology Copyright © 2008. All rights reserved.