Observational studyEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2025
Early clinical experience with a new supercritical CO
Observational study in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
STUDY
designProspective, single-center study
objectiveTo assess the efficacy, tolerance, and safety of BIOBank supercritical CO MATERIALS AND
methodsThis 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
resultsThe 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.
conclusionsThis 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.
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