Cerapedics, a privately-held orthobiologics company, today announced results of a study examining the efficacy and safety of the company's i-FACTOR™ biologic bone graft in posterior lumbar interbody fusion (PLIF), a common spine surgery to relieve chronic back pain. During the study, bridging bone inside hollow disc cages in the spine developed earlier with the use of i-FACTOR™ biologic bone graft when compared to autograft, while average pain decreased and function improved. Researchers led by Dr. Philippe Lauweryns, orthopedic surgeon at Sint-Trudo Ziekenhuis hospital in Belgium, concluded i-FACTOR™ biologic bone graft may be a viable alternative to autograft in PLIF procedures.
"There are alternatives to autograft and its associated risks, some of which may be more effective in the formation of bridging bone," said Dr. Lauweryns. "This study suggests that i-FACTOR biologic bone graft may have equal or greater efficacy at six and 12 months following PLIF procedures, and pain and functional improvements exceeded success criteria."
i-FACTOR™ biologic bone graft features synthetic small peptide (P-15) technology that supports bone growth through cell attachment and osteoblast differentiation. Dr. Lauweryns studied 40 patients undergoing PLIF surgery and assessed their progress using radiographs, CT scans, the Visual Analog Scale (VAS), and Oswestry Disability Index (ODI).
After six months, Dr. Lauweryns found intra-cage bridging bone occurred in 98 percent of patients treated with i-FACTOR biologic bone graft versus 59 percent of patients treated with local autograft. On average pain decreased 29 points and function improved 43 points.
"The use of autologous bone grafts in spinal fusion procedures has meaningful limitations including lack of availability of adequate volumes and quality of locally harvested bone. While the harvesting of autologous iliac crest bone can overcome these limitations, it creates the potential for complications including chronic pain and infection," said Glen Kashuba, CEO of Cerapedics. "We continue to lead the effort to identify and develop innovative biologic bone graft products that may replace or augment the use of autograft and this new study shows promise for our proprietary technology in PLIF patients."
Results of the study are published online by the International Journal of Spine Surgery in a paper titled, "Prospective Analysis of a New Bone Graft in Lumbar Interbody Fusion: Results of a 2- Year Prospective Clinical and Radiological Study"
WESTMINSTER, Colo., Feb. 17, 2015