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Orthopedic Implant Studies 

With exceptional expertise based on many years of testing experience, AppTec offers orthopedic medical device manufacturers a comprehensive program of custom implant studies.  These services are provided through AppTec's associate facility, Ibex Preclinical Research, Inc., located in Logan, Utah. 

THE IBEX FACILITY

Ibex is registered with the USDA and operates in accordance with the Guide for the Care and Use of Laboratory Animals.  The facility has the capacity to house multiple species for implant and toxicology studies.  A fully functional surgical suite has adjoining sterile preparation and animal prep areas.  Supporting equipment includes anesthesia, ventilator, suction, electrocautery, autoclave, radiography, implantable telemetry, angiography and ECG monitoring. 

PROGRAM FEATURES

•  Research, discovery, preclinical, and safety studies (GLP and Research)

•  Model development and study design development

•  Device design, materials evaluation and biocompatibility testing

•  In-house surgeons OR support for sponsor-provided surgeons

•  Radiography / flouroscopy capability

•  Animal Models:  Mouse - Rat - Rabbit - Dog - Sheep - Goat - Pig

•  Long-term, large-animal study capabilities

•  Experienced study director and veterinary research surgeon

•  In-house histopathology interpretation and clinical pathology evaluation 

IMPLANT MATERIAL EXPERIENCE

Experienced in a variety of orthopedic materials, including:

•  Dematerialized bone matrix combined with various carriers

•  Polymer with growth factors

•  Stem cells

•  Biologic polymers

•  Ceramics

•  Collagen-based injectables 

IMPLANT STUDY EXPERIENCE

Experienced in pilot, acute and chronic implant studies, including:

•  Segmental long bone defect models for critical size healing analysis

•  Drill defect models for bone healing and osteroinductive response

•  Posterolateral spinal fusion models for reconstruction

•  Articular cartilage repair/implant to evaluate cartilage restoration

•  ACL transection models to evaluate osteoarthritis treatment modalities

•  Synovial joint models to determine efficacy (ROM) of various injectables 

PROJECT PROGRESSION

> Client contacts Account Manager and consults with AppTec Study Director

> Study design and protocol are developed by AppTec Study Director

> Study is performed at Ibex

> QA is conducted by AppTec

> Final report is prepared and delivered by AppTec to client  

In addition to implant studies, AppTec offers complete biocompatibility / safety and toxicology testing.