Agent Used in Spinal Fusion Linked to Complications, Higher Costs
Reported July 01, 2009
(Ivanhoe Newswire) Back pain, a leading cause of disability in the U.S., is second only to the common cold as a reason for seeking evaluation by a physician. While nonsurgical interventions remain the first-line of therapy, many patients eventually progress to surgical treatments, with one option being spinal fusion.
A new study finds that bone-morphogenetic protein, (BMP), a biological agent used to promote bone creation, is associated with a higher rate of complication than in fusions that did not use BMP. Clinical use of recombinant BMP protein was approved by the U.S. Food and Drug Administration (FDA) in 2002 for surgery of the anterior lumbar spine. Results from the study indicate that nationwide usage of BMP increased from 0.69 percent of all fusions in 2002 to 24.89 percent of all fusions in 2006.
Kevin S. Cahill, M.D., Ph.D., M.P.H., of Brigham and Womens Hospital, Boston, and colleagues examined the national trends in the adaptation of BMP into clinical practice since 2002 and the association between BMP use and postoperative complications, length of stay and hospital charges. The analysis included data on 328,468 patients who underwent spinal fusion procedures from 2002 to 2006, identified from the Nationwide Inpatient Sample database, a 20 percent sample of U.S. community hospitals.
The researchers found that when comparing immediate postoperative, in-hospital rates of complications for the year 2006 among patients undergoing spinal fusion using BMP, no differences were seen for lumbar, thoracic, or posterior cervical procedures. After additional analysis, the use of BMP in anterior cervical fusion procedures was associated with a higher rate of complication (7.09 percent with BMP vs. 4.68 percent without BMP), with the primary increases seen in wound-related complications and dysphagia (difficulty in swallowing) or hoarseness. BMP use was associated with greater inpatient hospital charges across all categories of fusion. Increases between 11 percent and 41 percent of total hospital charges were reported, with the greatest percentage increase seen for anterior cervical fusion.
The authors write, “In conclusion, this report highlights the robust nationwide application of BMP in spinal fusion procedures in the first five years of clinical usage since FDA approval. The effects on complication occurrence in anterior cervical fusion, as well as the increases in length of stay and hospital charges, illustrate the need to continue to develop refined guidelines for usage and to further study the long-term risks and benefits of usage.”
SOURCE: Journal of the American Medical Association (JAMA), July 1, 2009.
