We used a newly developed, high-porosity unidirectional porous hydroxyapatite spacer (Regenos spacer, not approved by the FDA). To assess the short-term bone bonding capacity of Regenos spacer used in a… Click to show full abstract
We used a newly developed, high-porosity unidirectional porous hydroxyapatite spacer (Regenos spacer, not approved by the FDA). To assess the short-term bone bonding capacity of Regenos spacer used in a double-door laminoplasty, including displacement, deformation, and absorption after implantation. Fifty patients underwent a double-door laminoplasty using Regenos spacers, with computed tomography (CT) images obtained at 2-4 weeks and 6-12 months, post-surgery, in 30 patients. Bone bonding rate, amount of displacement, and the incidence of deformation and absorption were evaluated from the early and late postoperative CT images. Bone bonding rate for Regenos spacers, using our modified classification, was 48.9% at 6 months, post- surgery, and 67.0% at 12 months. The change in anterior-posterior diameter of the spinal canal (ΔH) was significantly greater for Regenos spacers than for autologous bone spacers (p < 0.05). There was no difference in the change in angle between the vertebral arch and the posterior wall of the vertebral body (ΔR) between the Regenos and autologous bone spacers. Deformation was identified in 21.3% (10/47). Though, no evidence of breakage along their long axis was identified among these 10 cases on axial CT images with passable clinical results. Regenos spacers lowered the risk of early dislocation after implantation and facilitated bone bonding due to infiltration of surrounding tissue. However, the deformation and absorption was observed at high rates because of their insufficient mechanical strength, we need to require a longer term follow-up to more clearly evaluate their adverse impact in clinically.
               
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