Abstract
The causes of a clinical tissue response to self-reinforced polyglycolide (SR-PGA) and self-reinforced polylactide (SR-PLLA) implants were studied in the first 2500 polymeric fixations. The incidence was 8.0% in fixations with implants made of SR-PGA (n = 1879) and 0% in SR-PLLA fixations (n = 621). A small number of fixations per site seemed to increase the incidence of a tissue response. In diagnoses involving over 50 fixations, except for ankle fractures, the incidence was 4.2%. The site of fixation influenced the incidence; the lowest incidence was seen for radial head fracture fixation (1.1%). The aromatic dye which has not been used since 1988 in the SR-PGA implant increased the response. A large total implant volume and a large number of implants increased the incidence of a tissue response. In the knee (n = 131), the incidence of a clinical tissue response was 4.3%, with four fluid accumulations and one synovitis of the knee after fixation with SR-PGA implants.
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