Degradable poly-lactic-co-glycolic acid and non-degradable polymer implants result in similar fracture healing at early timepoints.

BACKGROUND

Although rigid interfragmentary fixation is required for fracture repair, overly stiff implants are known to cause stress shielding which ultimately inhibits healing. While gradual dynamization of the fracture site both accelerates and improves osteogenesis, this approach requires external fixators or secondary surgeries. This study leverages biodegradable implants as mechanisms of gradual, passive dynamization during fracture healing.

METHODS

Using a rat femoral osteotomy model, additively manufactured poly-lactic-co-glycolic acid implants were compared to geometrically matched non-degradable biocompatible resin devices. Bone healing was assessed at 3 and 6 weeks via micro-computed tomography, histology, and mechanical testing. Implant degradation kinetics were assessed through testing of plates that were used in the rat model and with an unloaded in vitro degradation model.

FINDINGS: Quantitative bone measures made with micro-computed tomography, histology, and mechanical testing of the healing femora revealed no differences between degradable and non-degradable implants at 3 or 6 weeks. Degradable implants caused significant increases in bone volume to total volume mean density (p < 0.0001) and callus to cortical volume (p < 0.05) ratios between 3 and 6 weeks. Poly-lactic-co-glycolic acid devices were significantly stiffer than resin at week 0, but the two groups were equivalent by week 6 due to in vivo degradation. In vivo ambulatory loading caused significant losses of degradable implant stiffness at both 3 (p < 0.05) and 6 (p < 0.01) weeks, but this was not observed in the unloaded in vitro model.

INTERPRETATION: The results from this early timepoint study demonstrate the feasibility of passive, internal fracture dynamization driven by implant material mechanics.