AN OVERVIEW OF BONE GRAFTING AND THE AVAILABLE SOLUTIONS

Biocomposites develops, manufactures and markets synthetic calcium composite products for bone regeneration.

New and distinctive proprietary absorbable technologies are bioengineered to mimic, in vivo, the composite structure of human bone.

By understanding the physiology of human bone, Biocomposites has been able to engineer consistent, safe and readily available bone graft products with bone regenerative properties.
   
BONE GRAFTS - THE CURRENT POSITION

The incidence of bone graft procedures is continually increasing.

Traditionally, human musculoskeletal tissue is either harvested (usually the hip) from the patient (autograft) or from another donor individual (allograft).
 
THE PROBLEMS FACING THE SURGEON AND PATIENT

Three major problems, however, are increasingly confronting both the surgeon and patient communities.
The first problem surrounds material availability. With the continual increase in global demand for bone graft materials, there is a growing shortage of available allograft donor tissue.

The second problem involves patient safety and is presently giving particular cause for concern in the United States of America. Allografts are distributed through regional tissue banks where processing is carried out to eliminate potential infectious agents. Unfortunately, the processing compromises the bone remodelling properties of the allografts. Of more concern, are the recent cases of disease transmission to donor recipient patients, which have highlighted the difficulty of completely removing the infectious agents; despite the rigorous screening and processing to which the allografts are subjected.

Also, some allograft products such as demineralized bone matrix (DBM) or platelet gels, are not subjected to rigorous standards of regulatory scrutiny.

The third major problem surrounds the procedure for harvesting autograft bone from the patient. Tissue availability is often limited, sometimes not providing sufficient material for the operation. Also, the pain and discomfort caused to the patient (sometimes reported to be as high as 30 per cent of cases) can be considerable.
   
BONE PHYSIOLOGY

Bone is a composite structure wherein the inorganic component comprises approximately 65 per cent of its weight.

Often erroneously reported as calcium hydroxyapatite, the mineral (inorganic) component of bone does not, in fact, approach the highly crystalline state of hydroxyapatite and should be classed as a carbonate apatite, containing trace elements.

Living bone is regenerated through a dynamic process which continually removes bone (osteoclasts) and lays down new bone (osteoblasts). By this building process, bone is constantly being remodelled to the level of approximately 30 per cent in a year.

New bone is also realized through the activity of morphogenic proteins and the recruitment of cells and their differentiation into osteoprogenitor cells and osteoblasts (bone forming cells).

By appreciating the physiology of bone, synthetic bone graft materials can be engineered as osteoconductive scaffolds with engineered regenerative capacity involving the recruitment of vital inductive growth factors and bone forming cells.

OVERCOMING THE PROBLEMS - BIOCOMPOSITES' SOLUTIONS

To overcome these problems, alternative, totally synthetic bone graft materials, have, over the past decade been made available to the surgeon and patient.

By understanding the physiology of human bone, biomedical corporations, such as Biocomposites, have been able to engineer consistent, safe and readily available bone graft products with increasingly effective bone regenerative properties.

Synthetic bone graft materials require a number of key properties to enable appropriate bone regeneration.

Providing the material specification appropriate to the clinical indication is only possible with a versatile complement of synthetic processes.

Biocomposites, with an unparalleled corporate experience in calcium salts processing, has developed a unique family of products that have the following combined key properties.

BONE GRAFT MATERIALS - KEY PROPERTIES AVAILABLE IN BIOCOMPOSITES' GRAFT SOLUTIONS

• Osteoconductive host bed for growth factors
• Granular interconnected porous scaffold
• Absorption profile appropriate to the indication
• Controlled bioengineered chemistry
• Structural integrity for the mechanical regime
• Optimized handleability – granular matrices and non-exothermic injectable setting pastes

THE FUTURE

Recognising that different indications provide different bone grafting regimes in-vivo, Biocomposites has developed a family of synthetic absorbable bone graft solutions, bioengineered to provide a range of structural, chemical and absorption profiles.

Continuing our research into the bone forming and remodelling process will provide a better understanding of what is required in a synthetic bone graft product to enable the regeneration of bone to meet the increasing demand for bone graft procedures.