
November 4, 2002
The U.S. Food and Drug Administration (FDA) has notified healthcare professionals about complications related to the use of polymethylmethacrylate bone cement to treat osteoporotic compression fractures of the spine using surgical procedures known as vertebroplasty and kyphoplasty. Reported complications, such as soft tissue damage and nerve root pain and compression, are related specifically to the leakage of bone cement. Other reported complications include pulmonary embolism, respiratory and cardiac failure, and death.
Vertebroplasty involves the percutaneous injection of a mixture of polymethylmethacrylate bone cement and a contrast agent, typically barium sulfate, into the vertebral bodies using fluoroscopic and/or computed tomography guidance. Early vertebroplasty procedures were primarily performed to alleviate pain and to stabilize fractured bone in patients with hemangiomas, malignant metastases, or other types of tumors of the spine. The use of vertebroplasty to treat osteoporotic compression fractures in patients where conservative treatment has failed is relatively recent with no prospective, randomized, controlled trials to characterize its long-term safety or effectiveness.
In kyphoplasty procedures, a surgical instrument is introduced, with the intent to expand the vertebra. Once this instrument is withdrawn, the space created is then filled with the bone cement mixture. By creating space in this way, kyphoplasty procedures may correct deformity or restore body height. Like vertebroplasty, the use of kyphoplasty to treat osteoporotic compression fractures in patients where conservative treatment has failed is relatively recent with no prospective, randomized, controlled trials to characterize its long-term safety or effectiveness.
-- Article Courtesy of InjuryBoard.com
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