Henna Niiranen

Bioabsorbable scaffolds for guided bone regeneration and generation.

Several different bioabsorbable scaffolds designed and manufactured for guided bone regeneration and generation have been developed. In order to enhance the bioactivity and potential osteoconductivity of the scaffolds, different bioabsorbable polymers, composites of polymer and bioactive glass, and textured surface structures of the manufactured devices and composites were investigated in in vitro studies and experimental animal models. Solid, self-reinforced polyglycolide (SR-PGA) rods and self-reinforced poly L-lactide (SR-PLLA) rods were successfully used as scaffolds for bone formation in muscle by free tibial periosteal grafts in animal experiments. In an experimental maxillary cleft model, a bioabsorbable composite membrane of epsilon-caprolactone and L-lactic acid 50/50 copolymer (PCL/LLA) film and mesh and poly 96L,4D-lactide (PLA96) mesh were found to be suitable materials for guiding bone regeneration in the cleft defect area. The idea of solid layer and porous layer combined together was also transferred to stiff composite of poly 70L,30DL-lactide (PLA70) plate and PLA96 mesh which structure is introduced. The osteoconductivity of several different biodegradable composites of polymers and bioactive glass (BG) was shown by apatite formation in vitro. Three composites studied were self-reinforced composite of PLA70 and bioactive glass (SR-(PLA70 + BG)), SR-PLA70 plate coated with BG spheres, and Polyactive with BG.

Self-Reinforced Bioactive Glass-Bioabsorbable Polymer Composites

Non-reinforced and self-reinforced bioactive-bioabsorbable composite rods were produced by extrusion and solid state die-drawing using P(L/DL)LA matrix and spherical glass particles. The structure and mechanical properties of composites were measured before and after die-drawing. The structure examination of composites by SEM showed the formation of fibrous reinforced structure of the polymer with spindle-shaped pores around the glass spheres during and oriented in the direction of die-drawing. Incorporation of glass into the polymer matrix turns the composite more brittle compared to neat polymer. By die-drawing the brittleness of the composite can be eliminated. Not only the bioactivity and controlled degradation rate of composite but also structure and mechanical properties achieved during die-drawing make the self-reinforced bioactive glass- bioabsorbable polymer composites a novel implant material for temporary support of healing tissues.

Fixation of distal femoral osteotomies with self-reinforced poly(L/DL)lactide 70:30 and self-reinforced poly(L/DL)lactide 70: 30/bioactive glass composite rods. an experimental study on rabbits.

Two self-reinforced poly(L/DL)lactide 70 : 30 or self-reinforced poly(L/DL)lactide 70 : 30/bioactive glass (SR-P(L/DL)LA/bioactive glass) composite rods (2 mm × 40 mm) were implanted into the dorsal subcutaneous tissue and osteotomies of the distal femur were fixed with these rods (2 mm × 26 mm) in 36 rabbits. The follow-up times varied from 3 to 100 weeks. After the animals were killed, three-point bending and shear tests and molecular weight measurements were performed for subcutaneously placed rods. Radiological, histological, histomorphometrical, microradiographic and oxytetracycline-fluorescence studies of the osteotomized and intact control femora were performed. After 12 weeks the SR-P(L/DL)LA rods had fragmented into pieces and the mechanical properties could not be measured. The SR-P(L/DL)LA/bioactive glass rods lost their mechanical properties slower, and at 24 weeks the bending strength had decreased by 39% and the shear strength by 50%. After that the mechanical properties of the SR-P(L/DL)LA/bioactive glass rods could not be measured. All osteotomies healed well, and no gross signs of inflammatory reactions were observed. One slight displacement was seen in the three-week follow-up group with SR-P(L/DL)LA rods. Signs of resorption of the implants were seen after 48 weeks in the SR-P(L/DL)LA group and after 24 weeks in the SR-P(L/DL)LA/bioactive glass group. The SR-P(L/DL)LA/bioactive glass rods were almost totally resorbed from the bone at 100 weeks. The present investigation showed that the mechanical strength and fixation properties of the SR-P(L/DL)LA and the SR-P(L/DL)LA/bioactive glass composite rods are suitable for fixation of cancellous bone osteotomies in rabbits.