Cerapedics has reported positive results from the trial of its i-Factor biologic bone graft for patients undergoing posterior lumbar interbody fusion spine procedures.
At six and 12 months after treatment, data from 40 patients demonstrated superiority of i-Factor biologic bone graft over autologous bone.
The radiological fusion rate was 97.7% for patients treated with i-Factor, compared to 59.1% for patients treated with autograft.
The prospective, randomised, controlled trial was designed to evaluate the safety and efficacy of the i-Factor biologic bone graft compared to autologous bone delivered via interbody fusion cages in single and multi-level posterior lumbar interbody fusion surgery.
All patients served as their own control and also received posterior pedicle screw instrumentation.
The i-Factor technology combines anorganic bone mineral and synthetic small peptide P-15 to form an attachment factor for specific integrins on osteogenic cells.
Cerapedics’ i-Factor biologic bone graft received European CE Mark in late 2008, and is currently being evaluated in the US.