Harris Orthopaedics Laboratory: In vitro, In vivo Testing and Cadaver Laboratory

HOL tests and analyzes medical devices for use in total joint replacement, spine, fracture repair and osteoarthritis. Studies are tailored according to the need, for example, data generation for peer-reviewed publications, FDA regulatory submission, or blinded testing.

HOL conducts in vitro and animal testing based on ISO 10993 guidelines. Our facilities comply with the Office of Laboratory Animal Welfare (OLAW) National Institutes of Health standards. Protocols are submitted and reviewed by Institutional Animal Care and Use Committee (IACUCs) to ensure compliance with federal regulations.

HOL’s cadaver lab is available for use to test devices in both early and late stages of development.

Animal models are conducted for the following applications:

• Bone grafting
• Bone ingrowth and fixation
• Cartilage repair or replacement (ASTM F2451 - 05(2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage) https://www.ncbi.nlm.nih.gov/pubmed/25050611
• Fracture repair
• Local biocompatibility (paravertebral muscle implantation)
• Particle-induced osteolysis https://www.ncbi.nlm.nih.gov/pubmed/24998319
• Periprosthetic joint infection
• Total hip arthroplasty https://www.ncbi.nlm.nih.gov/pubmed/21084577

The following equipment and endpoints are available for use:

• Cell examination via light microscopy
• Complete blood count and chemistries
• Cone beam computed tomography (CBCT)
• Enzyme-linked immunotherapy assay (ELISA) to determine inflammatory cytokines or specific cluster differentiation (CD) markers
• Hard tissue embedding and sectioning, including metal implants
• Histological and immunohistological staining
• Inflammation assay via chemiluminescent L-012 probe
• LIVE/DEAD® Cell Viability Assays via fluorescent microscopy
• Micro-CT imaging (Scanco µCT 40)
• Paraffin tissue embedding
• Scanning electron microscope imaging (including backscatter)
• Tekscan Very High Resolution Walkway (pressure sensor)
• X-rays (C-arm Fluoroscopy)