Investigational Vertebroplasty Safety and Efficacy Trial (INVEST): Patient-reported Outcomes through 1 Year

被引：37

作者：

Comstock, Bryan A. ^{[1
]}

Sitlani, Colleen M. ^{[2
,3
]}

Jarvik, Jeffrey G. ^{[5
]}

Heagerty, Patrick J. ^{[1
]}

Turner, Judith A. ^{[4
]}

Kallmes, David F. ^{[6
]}

机构：

[1] Univ Washington, Dept Biostat, Seattle, WA 98195 USA

[2] Univ Washington, Dept Pediat, Seattle, WA 98195 USA

[3] Univ Washington, Dept Med, Seattle, WA 98195 USA

[4] Univ Washington, Dept Psychiat & Behav Sci, Seattle, WA 98195 USA

[5] Univ Washington, Harborview Med Ctr, Dept Radiol, Seattle, WA 98104 USA

[6] Mayo Clin, Dept Radiol, Rochester, MN USA

来源：

RADIOLOGY | 2013年 / 269卷 / 01期

关键词：

OSTEOPOROTIC VERTEBRAL FRACTURES; RANDOMIZED CONTROLLED-TRIAL; PERCUTANEOUS VERTEBROPLASTY; COMPRESSION FRACTURES; MODELS; PAIN;

D O I：

10.1148/radiol.13120821

中图分类号：

R8 [特种医学]; R445 [影像诊断学];

学科分类号：

1002 ; 100207 ; 1009 ;

摘要：

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]: 20.88, 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: 21.98, 3.30; P = .625) or pain (difference, 0.85 points; 95% CI: 20.35, 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. (C) RSNA, 2013

引用

页码：224 / 231

页数：8

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