( s said Frey. Approximately one-fourth ...)Sacroplasty Safe and Effective to Reduce Low Back Pain,Health

s, said Frey. Approximately one-fourth were pain-free at two weeks and about one-third at four weeks. Frey said there were no complications associated with the procedure at any time, though one patient died of what was deemed unrelated pulmonary disease within four weeks of undergoing the procedure. Excluding this patient, all but two patients reported 75% to 100% satisfaction at one year.

“Sacroplasty is a dramatic leap forward,” said Frey.

Most previous reports about sacroplasty have been small case series with short followup. They suggested that the procedure is technically feasible and leads to short-term pain relief. But there is scant prospective evidence on the safety and efficacy of sacroplasty in larger cohorts followed for longer periods of time.

Frey says the procedure can be technically demanding, and recommends physicians have extensive experience in vertebral augmentation. Potentially, cement can leak outside the sacrum and compromise the sacral nerve root, the sacral spinal canal, or sacroiliac joint.

Several years ago, the FDA issued a surprisingly sharp warning about the risks associated with vertebroplasty, including pulmonary embolism, respiratory and cardiac failure, and death. (FDA Public Health Web Notification: Complications related to the use of bone cement in vertebroplasty and kyphoplasty procedures, October 31, 2002; http://www.fda.gov/cdrh/safety/bonecement.html.)

Frey noted that sacroplasty is an off-label use of PMAA, and there is no Medicare code for the procedure, so reimbursement is problematic. His cost for one kit is about $400. He said he performs the service at no charge and receives no industry funding for his research.

Frey would like to see controlled trials to compare sacroplasty to a sham procedure. It is conceivable, he said, that sacroplasty is no better than placebo. In his study, none of the patients who declined sacroplasty was pain free at 12 weeks
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