1.1 This guide covers general guidelines for the in vivo assessment of tissue engineered medical products (TEMPs) intended to repair or regenerate bone in a rabbit knee condyle drill hole critical size defect model. TEMPs included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The rabbit knee condyle drill hole critical size defect model described in this guide is a critical size defect which, by definition, will not fill with viable tissue without treatment. Thus, this model represents a stringent test of a material’s ability to induce or augment bone growth.
1.2 Guidelines include a description and rationale of the rabbit (leporine) knee condyle drill hole critical size defect model. Outcome measures based on radiographic, histologic, and mechanical analyses are described briefly and referenced. The user should refer to specific test methods for additional detail.
1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in the Referenced Documents (Section 2).
1.4 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications.
1.5 Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
bone, critical size defect, knee, osteoconductive, osteoinductive, rabbit
This animal model is becoming a standard model used to evaluate bone forming potential of TEMPs. Industry, regulators, and test labs would benefit by having a standard guide to reference when designing and using this animal model to evaluate TEMPs.
The title and scope are in draft form and are under development within this