Purpose of the study: The efficacy of a new oestrogeneration biomaterial should be demonstrated by in vivo grafts in animal models. Critical filling of bone defects in the rat could be useful as a model before beginning studies in large animals such as the sheep, goat or dog. Creation of a critical defect in the rat femur has been described, but not standardized, leading to difficult comparison between series. In this work, we wanted to establish a detailed standardisable surgical protocol for the creation of a 6 mm femur defect in the rat.

Material and methods: We compared three anaesthesia protocols using 18 mal Wistar rats aged 21 weeks. We developed a surgical procedure enabling study of the advantages of the different commonly used surgical devices either in research or clinic to achieve osteosynthesis and a 6 mm bone defect. We also compared two types of fixation plates (and screws) available on the marker: a 1.2 mm thick titanium plate used for hand surgery and a 1.5 mm steel plate (veterinary medicine). Our postoperative clinical and radiographic follow-up was designed to validate our operative protocol and evaluate osteoregeneration.

Results: We demonstrated first that the use of multimodal anaesthesia radically improved the clinical outcome in the animals. We then demonstrated that the 1.2 mm titanium plates recommended in other studies were too fragile in our model and that the steel 1.5 mm veterinary plates were more adapted. We finally demonstrated the superiority of surgical devises to create a defect and for osteosynthesis. We described a postoperative protocol offering satisfactory evaluation, clinically and radiographically.

Discussion: This work is the first describing this protocol in detail. Improvements in feasibility and cost will make a readily exploitable model for other laboratories. The follow-up on this work should be aimed at improving the quality and pertinence of the analysis methods for the assessment of bone regeneration.

Conclusion: We propose a mode for the critical defect in rat femur bone as a reliable model for the study of osteogenic capacities of new biomaterials.