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In Vivo Bone Growth Assessment in Preclinical Studies and Clinical Trials

Exhibit 1: Pre-clinical Implant Osseo-integration

 

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  1. Histological cross-section of femur with implanted biomaterial (black). 
  2. Magnified view of orange rectangle shown in A. 
  3. Pseudo-colored representation of automated analysis output where green delineates segmented implant material and blue indicates newly formed bone. 
  4. Magnified view of orange rectangle shown in C., auto-generated red line outlines implant border and double yellow lines represent +/- 250 um from the implant border for “on-growth” analysis. 
  5. Micro-CT orthogonal views of sample shown in A. 
  6. Pseudo-colored, isosurface rendering of volume in E., where green represents segmented implant material, yellow delineates region of interest defined for analysis, and red indicates the analysis output for bone ingrowth.

 

ImageIQ would like to acknowledge and thank Sona Sundaramurthy and Biomet, Inc. for support in generating, and the use of, the data shown in this exhibit.

 

 

 

Unfortunately, in limiting the number of sections evaluated, the ability to accurately define levels of bone integration is significantly diminished, especially for amorphous materials where bone ingrowth can vary significantly throughout the interstices of the biomaterial. Such sub-sampling can add to the already existing population variability within a cohort of subjects, confounding the reliability of subsequent qualitative examinations. At the very least, under-sampling will result in reduced statistical significance. More damaging, however, incorrect interpretation due to sample binning can contradict true implant performance. The typical workflow for histological evaluation is shown in Exhibit 2.

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