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Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21.

Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year.

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  • 1Departments of Biostatistics, Pediatrics, Medicine, and Psychiatry and Behavioral Science, University of Washington, 4333 Brooklyn Ave NE, Box 359461, Seattle, WA 98195-9461; Department of Radiology, Harborview Medical Center, Seattle, Wash.

Abstract

PURPOSE:

To evaluate 1-year outcomes of the Investigational Vertebroplasty Safety and Efficacy Trial (INVEST), a blinded, randomized, controlled trial to investigate the effectiveness of percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures.

MATERIALS AND METHODS:

Patients were enrolled at 11 sites in the United States, the United Kingdom, and Australia by using an institutional review board-approved protocol and HIPAA compliance, and all patients provided written informed consent. Patients were randomized to undergo vertebroplasty or a control procedure. After 1 month, patients were allowed to cross over and undergo the alternate procedure. Coprimary outcomes were patient-reported function, measured with the modified Roland-Morris Disability Questionnaire (RDQ), and pain (on a scale of one to 10) at 1 year. Intention-to-treat (ITT) and as-treated (AT) analyses were used to compare outcomes.

RESULTS:

One hundred thirty-one participants (68 in the vertebroplasty group and 63 in the control group) were included in the analyses. Patients in both groups showed improvements in pain and function at 1 year. In ITT analyses, patients randomized to vertebroplasty did not differ from control subjects in terms of RDQ results (difference, 1.37 points; 95% confidence interval [CI]: -0.88, 3.62; P = .231) but reported lower levels of pain (difference, 1.02 points; 95% CI: 0.04, 2.01; P = .042). Eleven of 68 patients who underwent vertebroplasty (16%) and 38 of 63 control subjects (60%) crossed over and elected to undergo the alternate procedure (P < .001). In AT analyses, patients treated with vertebroplasty did not differ from control subjects in terms of RDQ results (difference, 0.66 points; 95% CI: -1.98, 3.30; P = .625) or pain (difference, 0.85 points; 95% CI: -0.35, 2.05; P = .166).

CONCLUSION:

Vertebroplasty may provide a modest reduction in pain at 1 year compared with a control procedure; however, no difference in functional disability was observed. Clinical trial registration no. NCT00068822.

© RSNA, 2013.

PMID:
23696683
[PubMed - indexed for MEDLINE]
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