Trial shows 98% fusion rate at 6-months and 12-months with i-FACTOR™ Biologic Bone Graft
Prospective, randomized, controlled trial demonstrates 98% fusion rate at 6-months and 12-months with i-FACTOR™ Biologic Bone Graft and superiority versus Autograft in single and multi-level PLIF spine surgery new European clinical study results presented at the Global Spine Congress, Barcelona, SPAIN, March 23-26, 2011.
WESTMINSTER, Colo. (April 11, 2011) — LifeHealthcare Pty Ltd, exclusive distributor in Australia and New Zealand for i-FACTOR™ biologic bone graft, welcomed the announcement from Cerapedics, Inc. of the results from a prospective, randomized, controlled trial of its i-FACTOR™ biologic bone graft for patients undergoing posterior lumbar interbody fusion (PLIF) spine procedures. The trial was performed by Philippe Lauweryns, MD, PhD from the Department of Orthopaedic Surgery, Regionaal Ziekenhuis Sint Trudo Hospital in Sint Truiden, Belgium.
The objective of the study was to evaluate the safety and efficacy of Cerapedics’ novel i-FACTOR biologic bone graft compared to autologous bone delivered via interbody fusion cages in single- and multi-level PLIF surgery. All patients served as their own control and also received posterior pedicle screw instrumentation. Outcomes included VAS for pain, Oswestry Disability Index (ODI) and radiographic images. The occurrence of complications or adverse events was also recorded. In addition to x-rays, the study utilized CT scans taken at 6-month and 1-year intervals. Fusion at the operative levels was defined as the presence of “bridging bone” and was assessed by a board certified independent radiologist.
At 6- and 12-months after treatment, data from 40 patients (45 levels) demonstrated superiority of i-FACTOR biologic bone graft over autologous bone. A radiological fusion rate of 97.7% for patients treated with i-FACTOR compared to 59.1% for patients treated with autograft (p less than 0.01). These results compare with the one-year data, which demonstrated a radiological fusion rate of 97.8% for patients treated with i-FACTOR compared to 82.2% for patients treated with autograft (p less than 0.01). No wound problems, infection, hematoma nor radicular pain problems were reported in either group.
“We are extremely excited with the statistical superiority i-FACTOR Putty achieved in this European study versus autograft, the gold standard for spine fusion surgery. It allows us to build upon the 14 years of clinical experience this technology already has outside of spine,” said Andy Woods, Director of Commercialization – EMEA at Cerapedics. “Beyond the fusion success realized in this study, we continue to demonstrate the tremendous safety profile of our i-FACTOR platform.”
Andy Handwerker, Chief Operating Officer at Cerapedics, said, “This study further suggests that our i-FACTOR technology is associated with faster formation of bridging bone when compared to autologous bone in patients undergoing PLIF procedures. We continue to be very encouraged with the long-term clinical results for both the i-FACTOR Putty and i-FACTOR Flex products as they are being used in over 20 countries for a variety of spine, trauma and orthopedic indications.”
Cerapedics’ i-FACTOR biologic bone graft received CE Mark in late 2008 and has been utilized clinically in more than 3,500 spine and trauma surgeries worldwide. i-FACTOR biologic bone graft is currently being evaluated in the United States (FDA) as part of an Investigational Device Exemption (IDE) Clinical Study in the cervical spine.
i-FACTOR™ is the only biologic bone graft that utilizes a small peptide as an attachment factor intended to stimulate the natural bone healing process resulting in safe, predictable bone formation at a fraction of the cost of growth factors.
Since receiving CE Mark in 2008, i-FACTOR biologic bone graft has been used clinically in over 3,500 spine, trauma and orthopedic procedures and is commercially available in over 20 countries outside the United States.