Outcome Analysis of Osseous Ingrowth in an Artificially Created Gap Non-union Using the Novel 3D Biodegradable Polycaprolactone Poly-l-Lactide Polymer Scaffold: Insights from an Experimental Study.

Background: Synthetic biopolymers have been widely used to manage bone effects in recent years. The study aims to analyse the ability to repair artificially created ulnar bone defects with the scaffold made of Polycaprolactone (PCL) and investigate the material's feasibility as a bone graft substitute. Method: We have tested a novel 3D biodegradable Polycaprolactone Poly-l-Lactide polymer scaffold in an experimental animal model. 14 adults New Zealand white rabbits were used to create the ulnar defect model of 10 mm in length, and randomly divided into group A (test-12 rabbits), group B (control-3 rabbits). The defect area was implanted with the PCL scaffold in the test group, whereas it was left as such in the control group. The repairing effect was observed by gross, histology, radiology, and the Scanning electron microscopy (SEM) at 4, 8, and 12 weeks. Cook's scoring was used to assess the radiological parameters. Results: Histological and radiological results showed better quality of bone regeneration in the defect area at 12 week follow-up period. The SEM image at that period showed impregnation of the osteogenic cells in the surface and pores of the scaffold material. It was evident that the scaffold was thoroughly degraded, corresponding with osteogenesis. New bone formation was statistically significant in the test group than in the control group. Conclusion: The Polycaprolactone Poly-l-Lactide polymer scaffold is biodegradable in-vivo at a suitable half-life. It has an excellent porous structure, no tissue toxicity, excellent mechanical strength, high osteogenesis potential, and osteoconductivity. Therefore, it can be used as bone graft material in the gap non-union and as a void filler in bone defects.