Supplementary file 1_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).docx

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.</p>Results<p>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.</p>Conclusion<p>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.</p>