ANALYZING THE INFLUENCE OF DEGRADABLE IMPLANTS ON BONE HEALING WITH μ-COMPUTERTOMOGRAPHY (μ-CT) AND A VALIDATED BENDING STIFFNESS DEVICE

Abstract

Introduction: Fractures in long bones are frequently managed with intramedullary implants, plates ore external fixators. X-ray images are normally used to determine the point of full weight bearing and implant removal. Plain radiographs give only poor information about the mechanical properties of the healing callus. Several quantitative Methods: like QCT and DEXA provide information about the density of the new bone, but the mechanical properties remain unknown. For direct monitoring of the mechanical properties of the healing callus a 4-point-stiffness device for small animals was constructed. This devise is used to detect the influence of degradable implants on bone healing. Long term aim is to develop “smart” implants that degrade during healing and speed up the healing process.

Materials and Methods: An uniplanar, bilateral external fixator was mounted on the tibiae of New Zealand White Rabbits after osteotomy and introduction of different degradable, intramedullar implants. The 4-point-bending measurement unit was temporarily fixed to record deflection with a non-contact displacement transducer. Load cells were instrumented to record the stepwise load increase (25g). The max. bending moment was only 0.14 Nm to avoid bending of the implant. Additional μ-CT analysis was conducted on the stiffness measurement days to quantify bone healing. After the in-vivo tests the stiffness measurement device was validated with ex-vivo measurements of bone models in a Material Test System (MTS).

Results: The bending stiffness unit showed a high precision with a standard deviation of 5.55E-04 N/μm and a mean deviation error of all models of 1.74E-04 N/μm. We found a significant non-linear correlation between the measured stiffness and the diameter of the models (p< 0.05, r2=0.96). Furthermore a significant correlation between the stiffness device and the MTS in vitro was shown (r2=0.96, p< 0.005). A significant correlation between the data of the bending stiffness device and the MTS was found for all animals (r2=0.64, p< 0.01). μ-CT analysis showed an increase in callus formation and density during the increase in bending stiffness.

Discussion: In this study a precise measurement unit to mirror the mechanical properties of healing bone is presented. The device was successfully tested in an in-vivo model of fracture healing. The healing of callus around different degradable implants can be monitored to develop implants that degrade during fracture healing to avoid stress shielding or implant removal. Not only data about the healing bone can be gatherd with the μ-CT analysis, but also processes around the implants can be well monitored to evaluate degradation and quality of the implants.