A Randomized Trial Comparing Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures due to Osteoporosis

This report has been verified by one or more authors of the original publication.

381 participants with vertebral compression fractures were randomized to receive either balloon kyphoplasty or vertebroplasty as treatment. The purpose of this study was to compare the safety and efficacy of the two treatments. The results indicated that the two procedures provided similar outcomes in terms of pain, disability, and quality of life over the next 2 years. Mean procedure duration was longer and there was lower cement extravasation in the kyphoplasty group. This study was terminated by the sponsor with only 404 patients out of the 1234 sample size goal (32.7%) due to high rates of withdrawal and limited enrollment. Further evaluations that meet predetermined sample size calculations are needed to provide a sufficient comparison between the treatment methods.