Orthobiologics in spinal fusion: 5 key notes on outcomes for Cerapedics' i-FACTOR

Spine

Orthobiologics company Cerapedics reported results from the FDA investigational device exemption clinical trial for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures, published in Spine.

Here are five key notes on the randomized, single-blinded study patients received either autograft or i-FACTOR:

 

1. There were 154 patients who underwent the procedure with bone graft and autograft and 165 with i-FACTOR bone graft. The i-FACTOR bone graft reported 88.9 percent fusion rate, compared with the control group with 85.8 percent fusion rate.

 

2. There was high neurological success rate for i-FACTOR and the control group — 93 percent.

 

3. There wasn't any difference in the adverse event rates for both groups.

 

4. The overall success rate for the four primary outcomes showed 69 percent success factor for the i-FACTOR bone graft, compared with 57 percent in the autograft group. The difference was statistically significant for superiority.

 

5. The i-FACTOR bone graft is based on synthetic small peptide technology and sports bone growth through cell attachment and activation. The technology has FDA approval for use in ACDF procedures for patients with degenerative cervical disc disease.

 

"Until now, alternatives to autograft bone for use in ACDF procedures had not been evaluated in rigorous randomized, controlled studies," said co-investigator and lead author of the Spine paper Paul M. Arnold, MD, professor of neurosurgery at University of Kansas Medical Center. "This study demonstrates that treatment with i-FACTOR bone graft results in similar and on some metrics superior outcomes compared to local autograft bone."

 

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