Therapeutic effect of percutaneous vertebroplasty and nonoperative treatment on osteoporotic vertebral compression fracture: A randomized controlled trial protocol

BACKGROUND: Osteoporosis and related complications have been increasing with the aging population. Osteoporotic vertebral compression fractures (OVCFs) are the most common among all osteoporotic fractures. The purpose of this study was performed to compare the efficiency and safety of vertebroplasty versus conservative treatment for acute OVCFs. METHODS: The conduct of this study followed the Declaration of Helsinki principles and the reporting of this study adhered to the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials. Written informed consent was obtained from every participant. Participants were randomly assigned (1:1) to receive either vertebroplasty or control group. The primary outcome was pain relief at 1 month and 1 year, measured with a Visual Analogue Scale score. The secondary outcomes were Roland-Morris Disability Questionnaire, short form score, European Quality of Life-5 Dimensions, and postoperative complications. RESULTS: We hypothesize that vertebroplasty will provide a rapid decrease of pain and an early return to daily life activities compared with the control group. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5624).