SUMMARY:In medical sciences, any experimental animal model should be reproducible and adequate to the purpose of simulated human physiological response. In bone injury response research, when bone substitutes are in use, it is of primary importance that studied defects fail to heal unless treated with the tissue engineering therapy under study. This failure defines the concept of "critical size defect" (CSD) wich has different limits according to the animal species used and the location of the defect. Although this is a basic concept, when the aim of the study is to investigate the interface Bone-Biomaterial, it is of primary importance to obtain as much contact area as possible. In order to do so, we propose a modified surgical approach to the classical bi-parietal round sub-critical defect model in rabbit vault.

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treatment (p = 0.070). Their 22 PGIC scores showed that 64% improved; 18% worsened. Among the 8/31 (26%) IVIG-responders (N30% pain reduction), pain dropped from 7.1 ± 1.6 to 3.2 ± 2.3, and half of their universally abnormal baseline AFTs normalized. 40% reported PGIC improvement. Infusion reactions were typical and manageable, including one hemolytic anemia and several vein thromboses. Conclusion: This preliminary evidence of IVIG efficacy and safety in select SFPN patients provides rationale and effect sizes for larger studies.

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