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

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 Disabi

SUBMITTER: Comstock BA 

PROVIDER: S-EPMC3781356 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature