A2.19. Supplementary Materials for Appendix 2

Transcription

1 A2.19 Supplementary Materials for Appendix 2

2 A2.20 Parameter Ref. Low Ref. High 12 Month 6 Month 3 Month Rabbit ID# B-51 B-71 B-51 B-52 B-53 B-54 B-55 B-56 B-57 B-58 B-59 B-60 B-61 B-62 B-63 B-64 B-65 B-66 B-67 B-68 B-69 B-70 B-71 Glucose AST ALT Alk. Phosphatase *** Ck (CPK) Total Bilirubin Total Protein Albumin Globulin Cholesterol Urea Nitrogen Creatinine Calcium Phosphorus Sodium Potassium *** Chloride TCO2 Anion Gap Erythrocytes Homoglobin Hematocrit MCV MCH MCHC Platelets Plasma Protein Specific Pathogen Free New Zealand White Rabbit Blood Chemistry and CBC PCV Total Leucocytes Heterophils (%) Lymphocytes (%) Monocytes (%) Basophils (%)

3 A2.21 All Animals Histology Data - Liver and Kidney ID# Organ Changes Acute Tubular Necrosis Comment 51 Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Kidney Liver Comment 1 change in the liver was minimal and around the portal vein/venule regions 2 Mild autolytic changes 3 Frequent deposits of dystrophic calcification in cortical distal tubule. Significance unknown

4 A2.22 Rabbit ID Slide ID Material Finish 3 Month Sacrifice Histology Data - Bone Samples Fibrosis Degeneration Infiltration Granulomatous Bone Remodeling Necrosis Comment Grade Thickness 65 BR-1 LM1 Polished BR-2 LM1 Bead Blasted BL L Polished BL L Bead Blasted BR-1 LM1 Polished BR-2 LM1 Bead Blasted BL L Bead Blasted BL L Polished BR-1 LM2 Bead Blasted BR-2 LM2 Polished BL L Polished BL L Bead Blasted BR-1 LM2 Polished BR-2 LM2 Bead Blasted BL L Polished BL L Bead Blasted BR-1 LM1 Polished BR-2 LM1 Bead Blasted BL-1 LM2 Bead Blasted BL-2 LM2 Polished BR-1 LM1 Bead Blasted BR-2 LM1 Polished BL-1 LM2 Bead Blasted BL-2 LM2 Polished BR-1 LM1 Bead Blasted BR-2 LM1 Polished BL-1 LM2 Polished BL-2 LM2 Bead Blasted Comment 1 Recut requested on original samples - no improved visualization on recut noted

5 A2.23 Rabbit ID Slide ID Material Finish Grade 3 Month Sacrifice Histology Data - Muscle Samples Fibrosis Thickness Intracaps Inflamm Degeneration Infiltration Grade Extracapsular Distance Granulomatous Necrosis Comment 65 MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished MR-4 LM1 Bead Blasted ML L Polished ML L Bead Blasted ML L Polished ML L Bead Blasted MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished MR-4 LM1 Bead Blasted ML L Bead Blasted ML L Polished ML L Bead Blasted ML L Polished 1 67 MR-1 LM2 Bead Blasted MR-2 LM2 Polished MR-3 LM2 Bead Blasted MR-4 LM2 Polished ML L Polished ML L Bead Blasted ML L Polished ML L Bead Blasted MR-1 LM2 Bead Blasted 1 68 MR-2 LM2 Polished MR-3 LM2 Bead Blasted MR-4 LM2 Polished ML L Bead Blasted ML L Polished ML L Bead Blasted ML L Polished MR-1 LM1 Bead Blasted MR-2 LM1 Polished MR-3 LM1 Bead Blasted MR-4 LM1 Polished

6 A ML-1 LM2 Polished ML-2 LM2 Bead Blasted ML-3 LM2 Polished 1 69 ML-4 LM2 Bead Blasted MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Bead Blasted MR-4 LM1 Polished ML-1 LM2 Bead Blasted ML-2 LM2 Polished ML-3 LM2 Bead Blasted ML-4 LM2 Polished MR-1 LM1 Bead Blasted MR-2 LM1 Polished MR-3 LM1 Bead Blasted MR-4 LM1 Polished ML-1 LM2 Polished ML-2 LM2 Bead Blasted ML-3 LM2 Polished ML-4 LM2 Bead Blasted Comment 1 Recut requested on originl samples - no improved visualization on recut noted 2 Chronic (lymphocytes & plasma cells) intra and extracapsular inflammation in one small focus 3 Chronic inflammation 4 Chronic inflammation with rare eosinophils 5 Focal fibrosis extending 2 mm into tissue 6 Fibrosis extensa 7 Chronic inflammation focal 8 Transformation into bone containing marrow

7 A Month Sacrifice Histology Data - Bone Samples Degeneration Infiltration Granulomatous Bone Remodeling Necrosis Comment Rabbit ID Slide ID Material Finish Fibrosis Grade Thickness 58 BR-1 LM1 Polished BR-2 LM1 Bead Blasted BL L Polished BL L Bead Blasted BR-1 LM1 Polished BR-2 LM1 Bead Blasted BL L Bead Blasted BL L Polished BR-1 LM2 Bead Blasted BR-2 LM2 Polished BL L Polished BL L Bead Blasted BR-1 LM2 Polished BR-2 LM2 Bead Blasted BL L Polished BL L Bead Blasted BR-1 LM1 Polished BR-2 LM1 Bead Blasted BL-1 LM2 Bead Blasted BL-2 LM2 Polished BR-1 LM1 Bead Blasted BR-2 LM1 Polished BL-1 LM2 Bead Blasted BL-2 LM2 Polished BR-1 LM1 Bead Blasted BR-2 LM1 Polished BL-1 LM2 Polished BL-2 LM2 Bead Blasted

8 A2.26 Rabbit ID Slide ID Material Finish Grade 6 Month Sacrifice Histology Data - Muscle Samples Fibrosis Thickness Intracaps Inflamm Degeneration Infiltration Grade Extracapsular Distance Granulomatous Necrosis Comment 58 MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished MR-4 LM1 Bead Blasted ML L Polished ML L Bead Blasted ML L Polished ML L Bead Blasted MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished MR-4 LM1 Bead Blasted ML L Polished ML L Bead Blasted ML L Polished ML L Bead Blasted MR-1 LM2 Polished MR-2 LM2 Bead Blasted MR-3 LM2 Polished MR-4 LM2 Bead Blasted ML L Polished ML L Bead Blasted ML L Polished ML L Bead Blasted MR-1 LM2 Bead Blasted MR-2 LM2 Polished MR-3 LM2 Bead Blasted MR-4 LM2 Polished ML L Bead Blasted ML L Polished ML L Bead Blasted ML L Polished MR-1 LM1 Bead Blasted MR-2 LM1 Polished MR-3 LM1 Bead Blasted MR-4 LM1 Polished

9 A ML-1 LM2 Polished ML-2 LM2 Bead Blasted ML-3 LM2 Polished ML-4 LM2 Bead Blasted MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished MR-4 LM1 Bead Blasted ML-1 LM2 Bead Blasted 1 63 ML-2 LM2 Polished ML-3 LM2 Polished ML-4 LM2 Bead Blasted MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished 1 64 MR-4 LM1 Bead Blasted ML-1 LM2 Polished ML-2 LM2 Bead Blasted ML-3 LM2 Polished 1 64 ML-4 LM2 Bead Blasted Comment 1 Recut requested on originl samples - no improved visualization on recut noted 2 Chronic (mainly plasma cells) inflammation 3 Chronic inflammation mainly lymphocytes 4 Chronic inflammation 5 Chronic inflammation intra % extracapsular - acute inflammation intracapsule 6 One focus chronic inflammation 7 Mixed inflammation 8 Mixed inflammation lymphs & neutrophils & few eosinophils 9 Focal chronic 10 Chronic inflammation focal extension of capsule fibrosis

10 A Month Sacrifice Histology Data - Bone Samples Degeneration Infiltration Granulomatous Bone Remodeling Necrosis Comment Rabbit ID Slide ID Material Finish Fibrosis Grade Thickness 51 BR-1 LM1 Polished BR-2 LM1 Bead Blasted 1 51 BL L Polished BL L Bead Blasted BR-1 LM1 Polished BR-2 LM1 Bead Blasted BL L Bead Blasted BL L Polished BR-1 LM2 Bead Blasted BR-2 LM2 Polished BL L Polished BL L Bead Blasted BR-1 LM2 Polished BR-2 LM2 Bead Blasted BL L Polished BL L Bead Blasted 2 55 BR-1 LM1 Polished BR-2 LM1 Bead Blasted BL-1 LM2 Bead Blasted BL-2 LM2 Polished BR-1 LM1 Bead Blasted BR-2 LM1 Polished BL-1 LM2 Bead Blasted BL-2 LM2 Polished BR-1 LM1 Bead Blasted 3 57 BR-2 LM1 Polished BL-1 LM2 Polished BL-2 LM2 Bead Blasted Comment 1 Reorient 2 Improperly oriented 3 Partial specimen, incomplete - (specimen broke upon implant removal RVB)

11 A2.29 Rabbit ID Slide ID Material Finish Grade 12 Month Sacrifice Histology Data - Muscle Samples Fibrosis Thickness Intracaps Inflamm Degeneration Infiltration Grade Extracapsular Distance Granulomatous Necrosis Comment 51 ML L Polished ML L Bead Blasted ML L Polished ML L Bead Blasted MR-1 LM1 Bead Blasted MR-2 LM1 Polished MR-3 LM1 Bead Blasted MR-4 LM1 Polished ML L Polished ML L Bead Blasted ML L Polished ML L Bead Blasted MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished MR-4 LM1 Bead Blasted ML L Bead Blasted ML L Polished ML L Bead Blasted ML L Polished MR-1 LM2 Polished MR-2 LM2 Bead Blasted MR-3 LM2 Polished MR-4 LM2 Bead Blasted ML L Polished ML L Bead Blasted ML L Polished ML L Bead Blasted MR-1 LM2 Bead Blasted MR-2 LM2 Polished MR-3 LM2 Bead Blasted MR-4 LM2 Polished ML-1 LM2 Bead Blasted ML-2 LM2 Polished ML-3 LM2 Bead Blasted ML-4 LM2 Polished

12 A MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished MR-4 LM1 Bead Blasted ML-1 LM2 Polished ML-2 LM2 Bead Blasted ML-3 LM2 Polished ML-4 LM2 Bead Blasted MR-1 LM1 Bead Blasted MR-2 LM1 Polished MR-3 LM1 Bead Blasted MR-4 LM1 Polished ML-1 LM2 Polished ML-2 LM2 Bead Blasted ML-3 LM2 Polished ML-4 LM2 Bead Blasted MR-1 LM1 Polished MR-2 LM1 Bead Blasted MR-3 LM1 Polished MR-4 LM1 Bead Blasted 1 Comment 1 Recut 2 Hemorrhage in fat around capsule 3 Mixed inflammation (especially perivascular). Diffuse and predominantly lymphocytic 4 Focal chronic inflammation in a thickened capsular region 5 Intracapsular inflammation predominantly lymphocytes, however occasional neutrophils (~1 high power field) is identified The inflammation is located in the thickest part of the capsule 6 Chronic inflammation - focal and located in thick part of fibrosis 7 Focal chronic inflammation located perivascular in extracapsular region and adjacent capsule 8 Marked, diffuse chronic inflammation involving entire circumference 9 Mixed acute/chronic inflammation focally 10 Focal mixed inflammation in a region of capsule thickening 11 Chronic inflammation, diffuse and associated with thick capsular regions 12 Focal chronic inflammation