There is a strong preference for off-the-shelf products to support bone grafting and regeneration. Frost & Sullivan has identified some interesting biomaterials that have been designed for this process.
According to the National Ambulatory Medical Care Survey, an annual survey by the U.S. Centers for Disease Control and Prevention’s National Center for Health Statistics, 6.3 million bone fractures occur in the United States every year—a frequency of 2.4 fractures per 100 persons. The average American can expect to sustain two fractures during the course of his or her life.
Naturally, the probability of sustaining a fracture increases significantly as people age. The International Osteoporosis Foundation reports that nearly 75% of hip, spine and forearm fractures occur among patients aged 65 or older. It is easy to imagine the effect that bone fractures—and orthopedic conditions such as osteoporosis and arthritis—can have on a person’s productivity and quality of life. There are enough statistics available to paint a grim picture.
The silver lining is that the bone is a remarkable tissue: it displays a tremendous capacity for regeneration. This capacity can be further enhanced by supplying the repair site with growth factors or scaffolds that can aid the bone’s natural regeneration capabilities, which becomes particularly important when the fracture results in bone loss or when the damage to the bone is extensive—as is often the case in osteoporotic and arthritic patients. In these situations, bone grafting is often employed.
Bone grafting is the process of transplanting bone tissues from the patients themselves (autografting), or from donor cadavers (allografting), to the injury site. Autografting and allografting both have acknowledged advantages and disadvantages. Autografting requires an additional surgical site and a loss of healthy bone tissue from that site, both of which tend to increase recovery time. However, autografting is safe, and there is no risk of tissue rejection. Allografting presents logistical freedom in that there is no limit on the extent of bone tissue that can be taken from a cadaver; however, availability may not be immediate, and there is a need for processing and a risk of rejection.
All considered, there is a strong preference for off-the-shelf products to support bone grafting and regeneration. Frost & Sullivan has identified some interesting biomaterials that have been designed for this process.
GlassBONE by Noraker (Villeurbanne, France)
GlassBONE, as the name indicates, is a bone substitute that is made of a bioactive glass material. Specifically, the glass is referred to as 45S5 ceramic, and is made of silicon, sodium, phosphorus, and calcium oxide in a particular composition. This product supports osteointegration, a process that results in the direct adhesion of the biomaterial and the bone. GlassBONE has a strong affinity for biological fluids, and has the ability to double the pace of healing.
IngeniOs β-TCP Bioactive Synthetic Bone Particles by Zimmer Biomet (Carlsbad, Calif.)
IngeniOs β-TCP is a resorbable material that is prepared from silicated tricalcium phosphate of nonbiologic origin. It is porous and biocompatible, and it can be morphed into particles of different sizes for different applications. IngeniOs β-TCP particles are used in dentistry and in oral and maxillofacial surgeries. The product is innovative in that it is radio-opaque, which makes the implant visible during intra- and post-surgical imaging.
Bioactive Glass Scaffolds by Lawrence Berkeley National Laboratory (Berkeley, Calif.)
Lawrence Berkeley National Laboratory has collaborated with researchers from Imperial College London to develop and commercialize a bioactive glass material for orthopedic applications. The material, 6P53B, is described as both highly porous and strong—attributes that are usually contradictory. 6P53B notably has potassium and magnesium oxides, in addition to the compounds that 45S5 has. The material is manufactured by “robocasting,” a computer-aided process that builds the scaffold layer by layer.
MBCP Granules by Biomatlante (Vigneux-de-Bretagne, France)
MBCP Granules synthetic bone substitute is a biphasic calcium phosphate ceramic composed of 60% hydroxyapatite and 40% tricalcium phosphate. It dissolves in the body, helping new bone development through the discharge of calcium and phosphate ions. MBCP Granules are osteoconductive; they create a medium for new bone development. The granules have 70% porosity and are similar to cancellous bone. They have an interknitted network of macro- and micro-pores that create the foundation of bone cells and biological fluid equally within the matrix.
The Road Ahead
The main research areas for bioactive bone grafting are focused on reducing the granule size to the nanometer level, improving bioactivity of the material, and developing innovative fabrication processes. Research has established that nanometer particle size increases the osteoblast functions, such as bonding, multiplication and differentiation. Scientists are also trying to use polymers such as gelatin, collagen and chitosan in a composition with alumina, zinc oxide and titanium.
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