Orthopedic biomaterials are bioengineered substances that are used in orthopedic surgery. They replace various tissues and repair bones and tendons. The demand for orthopedic biomaterials has increased with the prevalence of osteoarthritis. This degenerative bone disorder affects approximately 32.5 million people in the US alone. Biomaterials used in orthopedic surgery often mimic the properties of natural bone structure and may even aid the body in regeneration.
An important characteristic of orthopedic biomaterials is their ability to perform the intended function and produce the appropriate host response. Various aspects of biocompatibility are addressed, including bio-inertia, biofunctionality, and biostability. High biocompatibility is desirable in new biomaterials, but this property is dependent on a variety of factors, including material chemistry, mechanical and structural properties, interaction with biological systems, and assessment methodologies.
Surface functionalization of implants is another important aspect of osseo-integration. As the surface of an implant is dynamic, cellular and bacterial interactions can occur. The cells and bacteria that live on the implant may not interact with the entire biomaterial surface. They may instead interact with the conditioning film on the implant. For instance, in March 2022, Synergy Biomedical, an advanced biomaterial technology provider in the U.S., launched BIOSPHERE® FLEX SP Extremities, an orthopedic biomaterial developed using glass granules in combination with a porous sodium hyaluronate carrier.
As per market survey by Coherent Market Insights, Global Orthopedic Biomaterial Market is estimated to be valued at US$ 11,896.5 million in 2020 and is expected to exhibit a CAGR of 9.9% during the forecast period (2020-2027).
Biological evaluation of orthopedic biomaterials includes in vitro and in vivo tests to assess their cytocompatibility, genotoxicity, and other properties. Cytotoxicity evaluations measure a biomaterial’s cytotoxicity by monitoring the adsorption of Neutral Red on the test compounds. In some cases, biomaterials can cause a cellular reaction, which can lead to tissue damage and cell death. To make sure a biomaterial is safe for humans, it must undergo biocompatibility tests.
The skin sensitization test measures the allergenic potential of orthopedic biomaterials. The most common skin sensitization assay is the guinea pig maximization test. This assay works by inducing a local immune response in the skin. The biomaterial is injected intradermally into the skin, or applied as a topical patch. The skin reactions are then measured at 24 and 48 hours after the patch is removed. The higher the score, the more allergic the biomaterial is likely to be.