TY - JOUR
T1 - Investigational Vertebroplasty Safety and Efficacy Trial (INVEST)
T2 - Patient-reported outcomes through 1 year
AU - Comstock, Bryan A.
AU - Sitlani, Colleen M.
AU - Jarvik, Jeffrey G.
AU - Heagerty, Patrick J.
AU - Turner, Judith A.
AU - Kallmes, David F.
PY - 2013/10
Y1 - 2013/10
N2 - 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: 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.
AB - 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: 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.
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U2 - 10.1148/radiol.13120821
DO - 10.1148/radiol.13120821
M3 - Article
C2 - 23696683
AN - SCOPUS:84884685920
SN - 0033-8419
VL - 269
SP - 224
EP - 231
JO - Radiology
JF - Radiology
IS - 1
ER -