Cerapedics has announced the publication of results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery in The Spine Journal. The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a statistically significantly higher fusion rate compared to allograft plus local bone.
“In Scandinavia, surgeons often consider performing non-instrumented fusion when there is instability in elderly patients, but allograft bone has notoriously low fusion rates in this population,” said Michael Kjær Jacobsen, the study’s principal investigator (Sector for Spine Surgery and Research, Middlefart Hospital, Denmark). “i-FACTOR shows an increased fusion rate versus allograft.”
Jacobsen led the double-blind, prospective, randomised study in more than 100 patients (60 years or older). Participants suffered from degenerative spondylolisthesis and underwent decompression and non-instrumented posterolateral fusion surgery, and were randomised to either i-FACTOR bone graft or fresh frozen allograft bone, both mixed with local bone graft. Results showed the fusion rate was significantly higher in the i-FACTOR bone graft group (50%) compared to the allograft group (20%) at one year (p <0.001). Patient reported outcomes at baseline and follow-up were similar between the two groups. Longer term follow-up to evaluate the maintenance of clinical outcomes is in process.
“This study is a valuable addition to our clinical evidence base,” said Glen Kashuba, chief executive officer of Cerapedics. “This is now our fourth prospective clinical study in which i-FACTOR Bone Graft has demonstrated a clear clinical benefit and builds upon our previously reported fusion in various spine applications.”
“We are very encouraged by the results of this level-1 human clinical study in an extremely challenging environment,” said Jeffrey G Marx, president, and chief operating officer. “These results are especially encouraging as we continue to advance an investigational device exemption (IDE) clinical trial in the USA evaluating the safety and efficacy of our next-generation bone graft in transforaminal lumbar interbody fusion (TLIF) surgery.”
i FACTOR bone graft has over 10 years of clinical success in Europe and was approved in the USA for use in anterior cervical discectomy and fusion (ACDF) procedures in 2015. The drug-device combination product is based on small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease. It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the US Food and Drug Administration (FDA). In 2018, the company enrolled the first patients in an IDE clinical trial evaluating the safety and efficacy of its next-generation product, P-15L Peptide Enhanced Bone Graft, for use in patients undergoing TLIF fusion surgery.