Clinical biocompatibility of biodegradable orthopaedic implants for internal fixation: a review.

When the polymeric material reaches the final stages of its degradation process, biodegradable orthopaedic fixation devices elicit a local foreign-body reaction. In most cases, the symptoms of this tissue response are subclinical and pass unnoticed, but in some patients a clinically manifest inflammatory foreign-body reaction ensues. Mild clinical reactions consist of a painful erythematous papule, those of medium severity show a sinus discharging polymeric debris for up to 6 months, and in the patients affected by a severe reaction, extensive osteolytic lesions may develop at the implant tracks. The histopathologic picture is that of a non-specific foreign-body reaction. For implants made of polyglycolide, the average incidence of the manifest reactions is 5%. When slow-degrading polymers are used, the incidence is lower. The tissue responses to polyglycolide manifest themselves 11 weeks after surgery, on an average, whereas foreign-body reactions to devices made of poly-L-lactide can emerge as late as 4 or 5 yr after the original fracture fixation operation. A poorly vascularized bone section, use of a quinone dye as an additive in the polymer, and an implant geometry with large surface area each seems to be associated with an increased risk of the occurrence of a foreign-body reaction. Yet in majority of the patients affected, no known individual marker of high risk is present. Some recent laboratory experiments indicate that it may be possible to diminish the risk of an adverse tissue response by incorporating alkaline salts or antibodies to inflammatory mediators in the implants. The results of in vitro and animal experiments, however, cannot always be directly extrapolated to humans. Only large-scale long-term clinical research will ultimately show which physico-chemical characteristics of a biodegradable orthopaedic implant provide the optimal clinical biocompatibility.