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Pain, disability decrease after augmenting vertebral fractures with bioceramic filler
Patients in two IDE studies had vertebroplasty or kyphoplasty with synthetic bone not PMMA.
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A bioceramic material used in vertebroplasty and kyphoplasty procedures to augment vertebral compression fractures proved safe and effective at up to 3 years follow-up, investigators said.
At the International Society for the Study of the Lumbar Spine 34th Annual Meeting Ben B. Pradhan, MD, reported results using Cortoss synthetic bone (Orthovita) in two FDA-approved pilot investigational device exemption (IDE) studies. Investigators at three U.S. centers used Cortoss material in 20 patients undergoing vertebroplasty (26 vertebrae) and those at five centers used it in 20 patients (26 vertebrae) undergoing balloon kyphoplasty.
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Cortoss is not FDA-approved for use in the United States.
Better profile
Pradhan reported results for fractures from T6 to L5. At follow up the decrease in Oswestry Disability Index and Visual Analog Scale scores was comparable in the vertebroplasty and kyphoplasty groups.
The number of reported cases of leakage was similar between the groups, Pradhan said.
Investigators sought to delineate Cortoss’ advantages over polymethylmethacrylate (PMMA). “It is not that PMMA is not effective. It is very effective. It is what we use. But there is room for improvement,” Pradhan told Orthopedics Today.
One reason investigators studied Cortoss for this indication: its exothermic profile is better than that of PMMA.
Using PMMA in the spine always has surgeons on edge, Pradhan said. “If there is an extravasation, not only is there mechanical pressure on the nerve but it’s going to heat up the area before it cures. The curing temperature may reach 100°C.”
Cortoss sets at about 43°C and cures in 4-6 minutes compared with PMMA which cures in about 2 minutes.
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Images: Pradhan BB |
Subsequent fractures
“Overall the number of adjacent level fractures in the survival analysis was about the same,” Pradhan said. Those fractures occurred earlier in the kyphoplasty group (4 weeks) than the vertebroplasty group (17 weeks).
But Cortoss may be associated with fewer subsequent fractures because it interdigitates better with bone due to its superior viscosity profile, Pradhan said. Investigators saw a “speckle pattern” of fill on computed tomography (CT) indicating optimally-delivered Cortoss whereas PMMA may end up as a bolus on CT, he said.
Other studies showed “there’s a thin rim of fibrous tissue around the cement and it does not contact the bone like Cortoss.”
The vertebroplasty group attained pain relief with about half as much Cortoss material as the kyphoplasty group (1.9 cc vs. 4.1 cc, per vertebra).
For more information:
- Ben B. Pradhan, MD, can be reached at The Spine Institute at St. John’s Health Center, 1301 20th St., Suite 400, Santa Monica, CA 90404. 310-828-7757; e-mail: bpradhan@espineinstitute.com. He is a consultant to Orthovita.
Reference:
- Pradhan BB, Bae H. A biomechanical comparison of vertebroplasty and kyphoplasty in treating vertebral compression fractures through clinical experience in two pilot studies using Cortoss. #51. Presented at the International Society for the Study of the Lumbar Spine 34th Annual Meeting. June 10-14, 2007. Hong Kong.