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)
In brief
All 15 patients fused by 12 months using b.Bone graft extender
In this 15-patient pilot, b.Bone granules mixed with patients' own bone were used in spinal fusion; scans showed fusion in 10 patients at 6 months and all 15 by 12 months. Reported adverse events were judged unrelated to the device, but the single-arm study had no comparison group, so larger trials are needed to confirm performance.
- Journal
- Frontiers in bioengineering and biotechnology (Q1)
- Published
- 25 September 2026
- Study design
- Non-randomized / quasi-experimental trial
- Evidence level
- Level 2, Moderate (CEBM 2b)
- Authors
- Giuseppe Tedesco, Cristiana Griffoni, Jӧrg Franke, Giuliana Nervuti, Paolo Spinnato, Gabriele Bilancia, et al.
- PMID
- 42857381
- DOI
- 10.3389/fbioe.2026.1851820
Why clinicians should know about it
- Picked for Spine Surgery (paper of the day, 12 October 2026): Posterolateral fusion feasibility with b.Bone graft
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.