Development of a degradable composite for orthopaedic use: in vivo biomechanical and histological evaluation of two bioactive degradable composites based on the polyhydroxybutyrate polymer.

As a direct method for the evaluation of tissue bonding to two polyhydroxybutyrate (PHB) based composites, a mechanical push-out test was performed on implants in the femur of mature Japanese White rabbits. Three composites were tested. The first, a hydroxyapatite/PHB (HA/PHB) composite showed an increase in interfacial shear strength (ISS) up to 8 wk, after which the ISS decreased due to degradation of the implant. The second composite was an HA/glass/PHB (HGP) composite and this gave lower values for the ISS attributed to ion release from the glass causing a soft tissue reaction at the interface. The third composite was a carbon fibre reinforced polysulfone (CFRP) and this showed high interfacial shear strength values, which continued to increase with time. These conclusions were supported by contact microradiography (CMR) and histology which showed enhanced endosteal bone growth for the HA/PHB but for the HGP, no periosteal or endosteal activity was detected. Interposed soft tissue for the HGP composite was difficult to discern, histologically, but it was proposed that this was the reason for the low ISS values. It was concluded that the high ISS values for the carbon fibre control were due to surface morphology allowing deep ingrowth of soft tissue and this was confirmed by SEM.