A new American study has found that bone-morphogenetic protein (BMP), which is used in 25 per cent of spinal fusion procedures there, is associated with a higher rate of complications than in fusions that did not use BMP.
BMPs promote bone creation and remodelling and clinical use of recombinant BMP protein was approved by the US Food and Drug Administration in 2002 for surgery of the anterior lumbar spine to promote bone fusion.
Against that background, US surgeons 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 2002-2006, identified from the Nationwide Inpatient Sample database, a 20 per cent sample of US community hospitals.
The researchers found that when comparing immediate postoperative, in-hospital rates of complications for the year 2006 among patients undergoing spinal fusion by BMP use status, 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 occurrence, with the primary increases seen in wound-related complications and dysphagia or hoarseness.
Results from the study also indicated that nationwide usage of BMP has increased from 0.69 per cent of all fusions in 2002 to 24.89 per cent of all fusions in 2006. “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 study’s authors concluded.
“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.”
JAMA 2009;302:58-66
About Gary Culliton
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