Early clinical experience with a new supercritical CO2 virus-inactivated bone paste allograft in cervical interbody fusion.

STUDY

DESIGN

Prospective, single-center study

OBJECTIVE

To assess the efficacy, tolerance, and safety of BIOBank supercritical CO2-treated bone paste for cervical interbody arthrodesis using grafts and plates.

MATERIALS AND

METHODS

This was a prospective, single-center, observational clinical study of 49 individuals (72 grafted levels) undergoing anterior cervical discectomy and fusion (ACDF) with interbody cages and grafting with a novel bone paste (BIOBank Synergy®, France) with fixation plates. The clinical and radiographic outcomes were evaluated at 3, 12, and 24 months.

RESULTS

The mean (SD) NDI improved significantly from 41.3 (17.0) preoperatively to 22.2 (19.7) at 24 months (p < 0.001). Median (IQR) neck pain significantly improved from 6.0 (3.0) preoperatively to 0 (4.0) at 24 months (p < 0.001), and median arm pain significantly improved from 3.25 (2.5) preoperatively to 0.0 (0.0) at 24 months (p < 0.001). In terms of quality of life, the mean physical score significantly improved from 37.8 (8.6) preoperatively to 45.1 (11.0) (p < 0.001) at 24 months. The cumulative fusion rate at 24 months post-operatively was 96.7%. Surgical ease of handling was excellent (9.9 ± 0.5 points/10 maximum). There were no graft-related serious adverse events.

CONCLUSIONS

This first clinical study of BIOBank bone paste shows that the material is acceptable to surgeons and results in good functional, radiological, and outcomes for patients requiring anterior cervical arthrodesis combined with interbody grafting with a fixation plate.