A novel device for treatment of osteonecrosis of femoral head: Feasibility and preliminary efficacy of animal study

Background: Interruption of blood supply will lead to necrosis of body tissues, such as osteonecrosis of femoral head (ONFH). Vascularization has always been regarded as one of the biggest challenges in tissue engineering. In the current study, a novel device was proposed to reconstruct blood supply of necrotic femoral head. Methods: Cryo-insult with liquid nitrogen method was adopted to establish the ONFH model. In experimental group, a novel scaffold carrying vascular bundle was implanted into the necrotic femoral head after decompression and the transplanted vascular bundles were anastomosed with the existing blood vessels around the hip. In control group, a traditional porous scaffold was inserted alone without vessels. Feasibility of this strategy was verified by animal experiments. Micro-CT analysis and histological evaluation were performed to investigate its preliminary efficacy. Results: Feasibility of this innovative treatment strategy had been successfully verified in animal experiments. In the area of necrosis repair, more bone tissue grew into the scaffold in experimental group than the control group evaluated by Micro-CT (three months: 29.66% VS 20.35%, P＜0.05; six months: 30.47% VS 25.10%, P＜0.05) and histological analysis (24.71% VS 16.45%, P＜0.05 ​at three months; 31.01% VS 20.60%, P＜0.05 ​at six months). Implanted vascular bundles had the potential to branch out many branches in the osteonecrosis repair area to facilitate blood supply reconstruction and bone repair. Conclusions: This study proposed a novel device with clinical application prospects in the treatment of ONFH. It has the potential to provide new possibilities for rebuilding the blood supply of femoral head and repairing osteonecrosis. Translational potential statement: The novel device proposed in this study has the potential to be applied to the treatment of early femoral head necrosis.