Breaking strength retention and histologic effects around 1.3-mm. ORTHOSORB polydioxanone absorbable pins at various...

Absorbable 1.3-mm polydioxanone (ORTHOSORB) pins were implanted in 75 New Zealand White rabbits in three sites: within the lateral subcutaneous tissue parallel to the femur, down the femoral intramedullary canal, and mediolaterally across the femoral condyles (transcondylar). Pins were harvested at periodic intervals up to 56 and 365 days for mechanical and histologic analyses, respectively. Mechanical analyses were performed by loading the pin in double shear. Histologic analyses were performed on the pin and surrounding tissue. Histologic observations revealed a typical nonspecific foreign-body reaction at all implant sites that resolved at 1 year after resorption of the pin. On histologic examination, there was complete resorption of the pin material in the subcutaneous site by day 182, and there was complete resolution of all response to the pin in six of nine rabbits by day 365. In the intramedullary site, pin material was completely resorbed, based on histologic examination, in five of six rabbits by day 182, and there was complete resolution of the response to the pin in eight of nine rabbits by day 365. The pin material was completely resorbed based on histologic examination of the transcondylar site by day 210, and there was complete resolution of the response to the pin in four of six rabbits by day 270 and in four of nine rabbits by day 365. No enlarged pin tracks or sinus formations were observed in or near the implants sites. The average initial shear strength as 171.4+/ 5.1 MPa, and the breaking strength retention decreased with increasing implantation time. Pins from the subcutaneous regions maintained above 97% of their initial strengths at 28 days, and those from the intramedullary canals maintained above 92%. At later times the strength of the pins implanted in the intramedullary canal decreased more rapidly than those from the subcutaneous region. Overall, the average breaking strength of the subcutaneous pins was significantly greater than that of the intramedullary pins at all time points beyond 14 days. These data indicate that the pins exhibited a strength retention profile sufficient to allow normal healing of bone without enlarged pin tracts, allergic reactions, or sinus formations.