A 24-month study of Cerapedics’ PearlMatrix P-15 peptide enhanced bone graft found it had better time-to-fusion and clinical success than a local autograft, according to a Dec. 17 news release.
Five things to know:
1. The controlled IDE study included 293 patients across 33 U.S. sites. The study evaluated PearlMatrix in single-level transforaminal lumbar interbody fusion for adults with degenerative disc disease.
2. At 24 months after surgery PearlMatrix met the primary endpoint of Composite Clinical Success and had statistical superiority compared to a local autograft. It was also associated with higher fusion rates compared to local autograft at 24 months.
3. There were no significant differences between treatment groups with respect to ODI improvement, neurological deficits (motor and sensory) and serious device-related adverse events.
4. At six months, PearlMatrix showed that more than twice as many patients were fused compared to a local autograft. Higher time-to-fusion rates continued through the 12-month and 24-month checkpoints.
5. The PearlMatrix bone graft is indicated for intervertebral body fusion and is intended to be used in conjunction with a PEEK TLIF device.
