ArticleFrontiers in bioengineering and biotechnology2026
A pre-market, open-label, single-arm study to evaluate b.Bone for posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal disease (b.Spine clinical trial).
Article in Frontiers in bioengineering and biotechnology, 2026. 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
Background: Spinal fusion requires a graft between the affected vertebrae to facilitate new bone ingrowth and subsequent fusion. While the gold standard for bone grafting remains the iliac crest autograft and local autograft, several different bone graft substitutes have been investigated. b.Bone is a EU class III Medical Device. b.Bone is a biomorphic calcium phosphate scaffold characterized by a hierarchical interconnected porous architecture designed to mimic the structural organization of trabecular bone. Although b.Bone is a CE-marked device to fill voids or gaps in the extremities and pelvis, this clinical investigation was specifically designed as a feasibility study to assess the safety and preliminary performance of b.Bone granules when used outside their intended scope. Methods: In this single-arm pilot study b.Bone was used as a bone graft expander mixed with autograft in a 1:1 ratio in posterolateral fusion surgery at two European clinical centers for the treatment of degenerative conditions of the thoracolumbar, lumbar or lumbosacral spine. Patients were treated with b.Bone up to three levels. Spinal fusion was assessed at 6 and 12 months follow up by CT scan. Moreover, surgical complications and quality of life were assessed. Results: 15 patients (mean age 57.1 years, eight male and seven female) were enrolled. At 6 months successful radiographic fusion was achieved in 10 out of 15 patients (66.7% success rate). All cases achieved successful radiographic fusion at the treated spinal levels with b.Bone within 12 months post-surgery. Significant improvement in back pain was observed starting from 6 weeks post-surgery. Patients' functional ability remained stable over time. During the clinical trial, a total of 27 adverse events (AEs) were observed. However, all these AEs were not related to the device. Conclusion: The results of this feasibility study support the non-inferiority of b.Bone as bone graft extender with respect to other synthetic ceramic biomaterials and reinforce the device's benefit-risk profile in thoracolumbar instrumented fusion.
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