Use of bone-bonding hydrogel copolymers in bone: an in vitro and in vivo study of expanding PEO-PBT copolymers in goat femora.

Polyactive(R) [polyethylene oxide-polybuthylene terephtalate (PEO-PBT)] refers to a group of copolymers with bone-bonding properties. In reference to these properties, PEO-PBT copolymers are currently being investigated for their possible use in orthopedic surgery and dentistry. PEO-PBT copolymers exhibit hydrogel behavior. When swelling in fluid is prohibited by mechanical confinement, the copolymers exert a swelling pressure on surrounding structures. In the first part of this study, these swelling pressures were measured in vitro. Polymers with different ratios of PEO-PBT exerted a swelling pressure of more than 2 MPa when tested in fluid between the cross-heads of a Hounsfield test-bench. In the second part of the study, the biocompatibility of PEO-PBT 55-45 and the effect of continuous intramedullary pressure of these copolymers on bone was investigated. Large cylinders of dry PEO-PBT 55-45 were implanted with a tight fit in the distal part of goat femora. Preswollen cylinders of PEO-PBT implanted in the opposite femur served as a control. Although it was assumed that the pressure of dry PEO-PBT on the bone would reach more than 2 MPa with press-fit insertion, no immediate hazardous effects of the expanding polymer were noticed within the first days postoperatively. The goats were sacrificed after 3, 9, and 25 weeks. Histological examination showed good implant-bone contact at different follow-up times in the distal femora with the dry implanted implants. The femora in which the preswollen cylinders had been implanted showed a thin layer of soft tissue between the PEO-PBT implant and bone. The swelling pressure exerted by dry press-fit implanted PEO-PBT implants is an important factor in creating a strong interface bond between PEO-PBT and bone. Copyright 2000 John Wiley & Sons, Inc.