Timothy S. Carey, MD, MPH
In patients with painful osteoporotic vertebral fractures, does vertebroplasty alleviate pain and improve physical functioning?
Randomized placebo-controlled trial (Investigational Vertebroplasty Safety and Efficacy Trial [INVEST]). ClinicalTrials.gov NCT00068822.
Blinded (patients, outcome assessors, and safety committee).*
11 centers in the USA, UK, and Australia.
131 patients ≥ 50 years of age (mean age 74 y, 76% women) with 1 (68% of patients), 2 (21%), or 3 (11%) recent (< 12 mo) painful osteoporotic vertebral compression fractures between levels T4 and L5 (with evidence of marrow edema on magnetic resonance imaging or increased vertebral-body uptake on bone scanning if fracture age was uncertain) and inadequate pain relief from medical therapy. Exclusion criteria included spinal cancer, substantial retropulsion of bone fragments, concomitant hip fracture, and active infection.
Percutaneous vertebroplasty involving injection of polymethylmethacrylate (PMMA) into the vertebral body (n = 68) or a control intervention without needle insertion (n = 63).
Disability, back pain in the previous 24 hours, and quality of life. The trial had > 80% power to detect a 1.5-point difference in pain score or a 3-point difference in disability score (α = 0.05).
98% (intention-to-treat analysis).
Groups did not differ for disability, pain (Table), or quality of life.
In patients with painful osteoporotic vertebral fractures, vertebroplasty did not reduce pain or improve disability or quality of life more than a control intervention.
Vertebroplasty vs control procedure for painful osteoporotic fractures†
† Pain was measured on a scale of 1 to 10 (worst), with 1.5 considered as the minimal clinically important difference; mean baseline pain score was 6.9 in the vertebroplasty group and 7.2 in the control group. Disability was measured by the modified Roland-Morris Disability Questionnaire on a scale of 0 to 23 (worst), with 3 considered as the minimum clinically important difference; mean baseline disability score was 16.6 in the vertebroplasty group and 17.5 in the control group.
‡CI defined in Glossary. Adjusted for center and baseline score.
Carey TS. Vertebroplasty was not effective for painful osteoporotic vertebral fractures. Ann Intern Med. ;151:JC6–9. doi: 10.7326/0003-4819-151-12-200912150-02009
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Published: Ann Intern Med. 2009;151(12):JC6-9.
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