This article is more than 5 years old. Information may no longer be current.

Study: Use of rhBMP in cervical spine associated with likelihood of complications

Despite an FDA notification in 2008 of its possible adverse effects in spine surgery, the use of recombinant human bone morphogenetic protein or rhBMP in cervical spine surgery has continued. In this recent study, researchers found rhBMP use was associated with a significantly higher likelihood of cervical-spine-specific complications.

“We found that a variety of patient, surgical, and institutional factors were associated with a higher likelihood of complication development after cervical fusion surgery. The use of rhBMP and the Charlson comorbidity score were significant independent predictors of the development of complications in both the univariate and the multivariate analysis. The association of the latter with complication development may be explained by the fact that patients with more comorbidities are generally more likely to develop complications,” Amit Jain, MD, and colleagues wrote in their study.

Researchers examined the Nationwide Inpatient Sample database and identified 1,064,372 patients aged 18 years or older who underwent cervical spine fusion surgery from 2003 to 2010. Of those patients, 84,726 patients, nearly 8% of them, received rhBMP during surgery.

The mean age of patients in the rhBMP group was significantly higher than in the group with rhBMP group, 54.6 years and 53.08 years, respectively.

Jain and colleagues wrote that after adjustment for other factors in the multivariate model, rhBMP use significantly increased the likelihood of several complications. They noted dysphagia, dysphonia, hematoma/seroma formation and neurological complications were increased in their study and wereo more common with anterior cervical fusion surgery in the study. Dysphagia had a 2% prevalence with rhBMP use.

“Despite these shortcomings, our study provides a comprehensive overview of patient, surgical, and institutional factors associated with rhBMP use and we reported cervical-spine-specific in-hospital complications that may develop as sequelae of rhBMP use. A thorough understanding of these factors and complications is essential to enable surgeons to weigh the risks of rhBMP use against its benefits,” Jain and colleagues. – by Robert Linnehan

Disclosures: None of the authors received payments or services, either directly or indirectly, from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the 36 months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work.