A single-arm retrospective feasibility study of biphasic calcium phosphate bone graft with submicron surface topography in anterior cervical discectomy and fusion (ACDF) procedures 6 months postoperative.

BACKGROUND

Spinal fusion surgeries are a common procedure for cervical trauma, degenerative spondylosis, and radiculopathy and/or myelopathy. Though this surgical approach has excellent patient clinical outcomes, there is a paucity of rigorous data quantifying fusion rates at early time points. This retrospective safety and feasibility study evaluates a biphasic calcium phosphate bone graft with submicron surface topography (BCP<µm putty) with or without autograft in anterior cervical discectomy and fusion (ACDF) procedures.

METHODS

An independent neuroradiologist blinded to the clinical status evaluated computed tomography (CT) images obtained at 6 months and graded each treated level based on the extent of bridging trabecular bone. Twenty subjects were enrolled in the study. A total of 43 spinal levels were treated with an average of 2.15 levels per subject (C3-C4 to C6-C7).

RESULTS

The primary endpoint of CT-based fusion was 97.7% (42/43 levels) based on the presence of bridging bone between the endplates at 6 months. This cohort included 35% of patients treated with BCP<µm putty with ICBG and 65% of patients fused with BCP<µm putty standalone. The observed fusion rates were accompanied by an improvement in pain scores. No graft-related adverse events (AEs) were reported. Limitations of this study include a small sample size and a heterogeneous surgical population.

CONCLUSIONS

The high fusion rate observed at 6 months postoperative and favorable safety profile support the performance of BCP<µm putty for use with or without autograft in cervical interbody fusion procedures.