Biological response of intramedullary bone to poly‐L‐lactic acid

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Abstract
This study focuses on examining the biological response of intramedullary bone to poly‐L‐lactic acid (PLLA), particularly during the PLLA degradation phase. To study the influence of spherical crystals (spherulites) of PLLA on intramedullary bone response, two different types of PLLA coupon, with and without spherulites but with the same molecular weight, were used. Chambers containing PLLA coupons were implanted into the right femur of eight dogs, four with and four without spherulites; chambers containing stainless steel (SS) coupons (as a control) were implanted in the left femurs of all eight. Two dogs, one with and one without spherulites, were sacrificed at 3, 6, 12, and 24 weeks postoperatively. Histomorphometric evaluation and histophathological assessment were used to compare the response to PLLA and SS. Scanning electron micrographs showed that there were minimal changes in the surface of PLLA coupons at 3 and 6 weeks. But at 12 and 24 weeks, there were many cracks and holes on the surfaces of the coupons, and some parts of the surface were scaling off. The cross‐sectional area of PLLA coupons showed no change at 3 and 6 weeks, but started to decrease by 12 weeks. The amount of ingrown bone between PLLA coupons was significantly greater than that between SS coupons at 3 and 6 weeks, but had decreased dramatically by 12 weeks. Extensive bone resorption around PLLA coupons occurred by 12 weeks accompanied by infiltration of inflammatory cells. An abundance of histiocytes, giant cells, and leucocytes were seen, along with a few histiocytes that had phagocytized PLLA particles of less than 2 μm. By contrast, no inflammatory reaction was seen in SS samples at any period up to and including 24 weeks. PLLA demonstrated excellent biocompatibility with intramedullary bone for the first 6 weeks in this model. Once degradation commenced, however, biocompatibility decreased dramatically. Our study detected no difference between coupons with and without spherulites. It thus appears that the existence of relatively large PLLA particles did not influence the response of intramedullary bone to PLLA, but rather that it was the smaller particles (< 2 μm) released from the PLLA that induced foreign‐body inflammatory reactions and bone resorption. It is also possible that a local decrease in pH occurred around PLLA coupons, which could have influenced vital kinetics. © 1993 John Wiley & Sons, Inc.