Use of rhBMP in Cervical Spine Linked to Complications

Roughly six years after a U.S. Food and Drug Administration notification of its possible adverse effects in spine surgery, the use of recombinant human bone morphogenetic protein, or rhBMP, in cervical spine surgery has continued. Now researchers have linked rhBMP use 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, M.D., 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 percent 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 were more common with anterior cervical fusion surgery in the study. Dysphagia had a 2 percent 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 said in the study.