Use of Orthopedic Biomaterials

MedTech Outlook | Saturday, May 02, 2020

Emerging orthopedic biomaterials must first be evaluated for preclinical safety and efficacy before being approved by regulatory agencies.

FREMONT, CA: Biomaterials in Orthopedics are generally preferred for their strength or ability to replicate the structure and properties of bone. They're also needed to promote tissue mineralization surrounding implants, which necessitates the use of bioactive materials. This frequently entails the usage of metals or ceramics. Calcium phosphate ceramics, notably synthetic hydroxyapatite (HA), have been produced for bone tissue restoration because they closely resemble apatite. They promote better bone formation in the areas around the ceramic implant than other materials, such as orthopedic metals. For the strength of metals and the calcium phosphates' bioactivity (i.e., osteoconductivity), metal implants covered with a bioactive ceramic material may be used in some situations.

The host's reaction to an orthopedic biomaterial includes its response to local tissue trauma and the implant itself. The innate immune system is involved in the immediate inflammatory response to the implantation technique, providing pattern recognition receptors on macrophages and other cells to recognize remnants of damaged extracellular matrix components and cellular elements. The first response sets off a chain of events that leads to tissue regeneration, fibrosis, or persistent inflammation. The host reaction is influenced by the implant's properties and any by-products. The genotype and phenotype of the host and the precise surgical technique of implantation are all critical factors of implant performance. While the innate immune system is always active when an orthopedic device is implanted, the adaptive immune system can also be activated in specific instances, such as when metal debris is present.

Before being approved by regulatory agencies, emerging orthopedic biomaterials must first be examined for preclinical safety and efficacy. The biocompatibility framework is summarized in this review to demonstrate an appropriate biological response and implant innocence and inertness. Once biocompatibility has been established, surgical implantation studies for efficacy, functioning, and performance testing can begin. For study designs that imitate the clinical context in orthopedics, state-of-the-art preclinical models are offered. Histology, histomorphometry, histopathology studies, imaging modalities, and mechanical tests are discussed to assess orthopedic biomaterials for safety and performance.