Results from a clinical trial evaluating i-FACTOR® Peptide Enhanced Bone Graft in non-instrumented lumbar fusion demonstrate that elderly patients treated with i-FACTOR bone graft plus local bone had a statistically significantly higher fusion rate vs. those treated with 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 Dr. Michael Kjær Jacobsen, principal investigator. “i-FACTOR shows an increased fusion rate versus allograft.”
The double-blind, prospective, randomized study involved more than 100 degenerative spondylolisthesis patients, 60 years or older, in Denmark. Participants underwent decompression and non-instrumented posterolateral fusion, randomized to either i-FACTOR bone graft or fresh frozen allograft bone, both mixed with local bone graft.
Recipients of i-FACTOR showed a 50% fusion rate vs. 20% in the allograft group at one year. Patient-reported outcomes at baseline and follow-up were similar between the 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.”
Cerapedics launched i‑FACTOR in 2016. The drug/device combination is based on synthetic small peptide technology that accelerates new bone formation. It is in a new category of bone graft technology and is one of only two drug/device combination products approved by FDA, joining Medtronic’s Infuse.