Radiographic, Histologic, and Chemical Evaluation of Bioresorbable 70/30 Poly-L-lactide-CO-D, L-lactide Interbody Fusion Cages in a Goat Model

In Brief Study Design. A study of lumbar interbody fusion using polylactic acid-based bioresorbable fusion cages in a goat model. Objective. To evaluate the effect of polylactic acid polymer composition, and internal stabilization on the rate and quality of interbody fusion. Summary of Background Data. A spinal cage should provide an appropriate biomechanical environment to facilitate interbody fusion. Previous studies have shown that bioresorbable polylactic acid-based cages can provide adequate stability for spinal fusion. However, at present and to our knowledge, the best bioresorbable materials, optimal cage stiffness, and desired period over which the cage should biodegrade are unknown. Methods. Interbody fusions were performed at L3–L4 level in 35 skeletally mature Dutch milk goats. Titanium and poly-L-lactide-CO-D,L-lactide (PLDLLA) cages were implanted at random as stand-alone cages. In addition, PLDLLA cages were implanted with anterior fixation. The goats were euthanized at 3, 6, or 12 months. Radiographic, magnetic resonance imaging, histologic, and histomorphometric analyses were performed on retrieved segments. Chemical analysis was used to assess degradation of the retrieved PLDLLA cages. Beforehand, chemical and mechanical degradation of the PLDLLA cages were assessed in vitro. Results. At 3 months, bone graft was almost completely remodeled. Endochondral bone formation was observed in all specimens. At 6 months, 50% of the PLDLLA stand-alone cages and 83% of the PLDLLA anterior fixation cages were fused. At 12 months, 38% of the PLDLLA stand-alone and 83% of the titanium cages realized fusion. A very mild and dispersed foreign body reaction was seen in all PLDLLA specimens. E-beam sterilized PLDLLA cages degraded more rapidly in vivo as compared to both, PLDLLA cages in vitro, and ethylene oxide sterilized poly-L-lactic acid cages in vivo. Conclusions. Within the 3—6-month period, PLDLLA stand-alone cages provided insufficient mechanical stability, which manifested as cracking and deformation of the cages and lower fusion rates. This result implies that within this time, additional stabilization is required; supplemental internal fixation proved sufficient to obtain successful fusion. In all cases, only a mild host response was seen, indicating good biocompatibility. The performance of polylactic acid-based bioresorbable interbody cages for lumbar fusion was investigated in a goat model. Variations in polylactic acid composition and processing led to different degradation properties of the cage and different clinical outcomes. E-beam sterilized poly-L-lactide-CO-D,L-lactide (PLDLLA) cages degraded more rapidly than ethylene oxide sterilized poly-L-lactic acid cages. Stand-alone PLDLLA cages could not provide adequate mechanical stability to warrant successful fusion. However, PLDLLA cages in combination with supplemental fixation performed as well as the titanium cages.