Abstract
Excellent reconstruction of bone will be described induced by a synthetic biomaterial without a calcium phosphate mineral phase or growth factors, and with a pore size of 35 m. The material is fabricated by a process called sphere-templating and it can be made from many synthetic materials including hydrogels, silicones, polyurethanes and glasses. All pores are identical in size and interconnected. Studies from our group have shown optimal healing in soft tissue (as suggested by extensive vascularity and minimal fibrosis) for spherical pores of 30–40 m size. Sphere-templated hydrogel implants in bone were performed using the following procedure: Under appropriate anesthesia, 18–24month old NZW rabbits underwent medial parapatellar arthrotomy, with exposure of the medial femoral condyle. A 3.5 mm end-cutting drill, locked in a rigid armature, was used to create a host graft site at the center of the articular cartilage lesion, with depth of cut matched to the sphere-templated construct thickness of 2 mm. Animals were sacrificed at one day, 28 days, and 12 weeks. After sacrifice, the femora were isolated and the condyles dissected. Condyles were fixed in 4% paraformaldehyde at 4°C for 48 hrs, decalcified in Immunocal for 14 days at 4°C and paraffin embedded. Specimens were sectioned to a thickness and stained with Safranin- O/Fast Green, hematoxylin/eosin or Masson's trichrome. Prior to decalcification, selected samples were evaluated by micro-CT utilising a Skyscan 1076 microCT low dose in-vivo X-ray scanner, slice imaging and 3D image reconstruction. Both histologically, and with micro-CT imaging, excellent tissue and mineral reconstruction was observed in the sphere templated material. The contralateral control, drilled but without implant, showed essentially no reconstruction.
Since the classical paradigm for bone reconstruction requires either autologous bone, cadaver bone, or calcium phosphate scaffolds with pores >150 microns, the healing observed here suggests new avenues for bone regeneration.
