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

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.