Orthobiologics company Cerapedics published data from a clinical trial examining the fusion rate of its i-Factor bone graft in noninstrumented lumbar fusion.
Featured as the lead article in The Spine Journal, the clinical trial demonstrated that older adult patients treated with i-Factor plus local bone achieved a higher fusion rate compared to allograft.
At one year, the fusion rate was 50 percent in the i-Factor group and 20 percent in the allograft group.
The study examined the bone graft in more than 100 patients with degenerative spondylolisthesis who underwent decompression and noninstrumented posterolateral fusion surgery.
i-Factor, which the FDA approved for use in anterior cervical discectomy and fusion procedures in 2015, incorporates a small peptide as an attachment factor to stimulate the natural bone healing process.
Cerapedics plans to conduct an investigational device exemption clinical trial to evaluate the safety and efficacy of i-Factor in transforaminal lumbar interbody fusion surgery.