מתוך medicontext.co.il
By Joene Hendry
DALLAS (Reuters Health) – In a pilot study of patients undergoing posterolateral lumbar spine fusion, continuous fusion was achieved using a purified extract of bone-derived bone morphogenetic protein (BMP), according to data presented here Friday afternoon at the American Academy of Orthopaedic Surgeons meeting.
"This is the first BMP product to be used without iliac crest bone graft in a human posterolateral fusion model," Dr. Scott D. Boden, of Emory University School of Medicine in Atlanta, told Reuters Health.
Dr. Boden and colleagues enrolled 22 patients (18 female) candidates for arthrodesis due to lumbar spinal stenosis and/or spondylolisthesis. The patients underwent standard autogenous iliac bone autograft on one side of the affected area of the spine, while the other side of the spine was treated with varying doses of the bovine-derived bone growth factor, known as Ne-Osteo BMP extract (Sulzer Biologics, Austin, Texas)
In the first group of patients, 12.5 mg bone growth factor was used on one side of the spine with autogenous iliac bone graft used on the other. Treatment resulted in fusion on the autograft treated side in four of six patients, while fusion occurred in only two patients on the side treated with 12.5 mg bone growth factor.
A second group of six patients received either 25 mg or 50 mg of bone growth factor. Dr. Boden reports that fusions were obtained on both sides in all six patients, "but the center did not fill in with bone," on the growth factor-treated side.
In a third group, 10 patients were treated with either local bone or allograft cancellous chips combined with 25 mg bone growth factor on one side and with the standard autograft on the other side of their spine. CT scan evaluation showed that all five patients receiving local bone chip plus bone growth factor and four of the five patients treated with the cancellous chip combination were fused after 6 months. The standard autograft side fused in 9 of the 10 patients after 12 months.
After 2 years of follow-up, Dr. Boden reports no adverse events from the bone growth factor treatment.
Dr. Boden noted the standard spinal fusion procedure is quite painful. "In addition," he said, "the healing success with someone's own bone is less than 80%."
In using bone growth factor, "efficacy…was dependent on the right concentration of growth factor and the use of an appropriate carrier matrix," Dr. Boden told Reuters Health.
Based on the findings, he concludes that "Ne-Osteo BMP extract can make consistent bone in the human posterolateral spine environment
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