Cerapedics has announced the results of a study examining the efficacy and safety of the company’s i-FACTOR biologic bone graft in posterior lumbar interbody fusion (PLIF) 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 Philippe Lauweryns, orthopaedic surgeon at Sint-Trudo Ziekenhuis hospital in Belgium, concluded that i-FACTOR biologic bone graft may be a viable alternative to autograft in PLIF procedures. The results were published in 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.”
“There are alternatives to autograft and its associated risks, some of which may be more effective in the formation of bridging bone,” said 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. Lauweryns studied 40 patients undergoing PLIF surgery and assessed their progress using radiographs, CT scans, the visual analogue scale (VAS), and Oswestry Disability Index (ODI).
After six months, Lauweryns and colleagues found intra-cage bridging bone occurred in 98% of patients treated with i-FACTOR versus 59% 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, chief executive officer 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.”