Biodegradable interlocking nails for fracture fixation.

Abstract

Serious problems such as stress shielding, allergic reactions, and corrosion are associated with the use of metallic fracture fixation devices in fractured long bones. Metal implants often are removed during a second retrieval operation after fracture healing has completed. A biocompatible implant that degrades slowly during implantation would obviate the need for a second operation and save the patient from considerable physical, psychologic, and financial discomfort. The biodegradable implant must provide the fractured limb sufficient support for a certain time, allowing early loading. A gradual transfer of load from the biodegradable implant to the bone would result in a better product of bone healing and avoid stress shielding. In an animal model using adult sheep, two types of biodegradable polymer interlocking nails were tested in comparison with a stainless steel interlocking nail. Fracture healing, mechanical properties of the bones, degradation behavior in vivo and in vitro, and tissue response were monitored during a 2 1/2-year followup study. To detect shifts in acid base relations caused by the release of acid compounds, pH measurements were performed. Fracture healing was unimpaired, and the mechanical test results of all three groups were excellent. Histologic analysis showed a mild inflammatory response, but no pH shifts were observed. The results of this study justify additional research on these promising materials.