ALLOGRAFT TISSUE BONE GRAFTING (Spine and Orthopaedic)

WHAT IS ALLOGRAFT TISSUE?

Allograft tissues are generously donated human tissues that come in many shapes and sizes. They have different purposes based on the procedure being performed. For example, mineralised allografts provide strength, while demineralised allografts enhance signalling for your own bone cells to form new bone.

WHAT IS DEMINERALISED BONE MATRIX?

Allograft that has not had its natural mineral phase removed (“mineralised allograft”) is structural and commonly used to replace the interbody disc between two vertebral bodies in the spine during an interbody fusion procedure.

Demineralised allografts (e.g., Grafton™ DBMs), on the other hand, have been processed in a manner that strips the natural mineral component away from the bone to expose native growth proteins. The native proteins exposed during the demineralisation process produce a signal to the body to recruit bone forming cells to that area and form new bone. These forms of allograft are called “demineralised bone matrix”, or DBM, and are commonly used to fill bony voids throughout the skeletal system, unlike mineralised allografts—they do not provide strength.

how IS ALLOGRAFT TISSUE made?

A doctor uses tissue processed by one of the major suppliers of allograft tissue to the orthopaedic, spinal, and dental markets. Medtronic only partners with reputable American Association of Tissue Banks (AATB)-accredited tissue banks. These tissue banks utilise aseptic techniques during recovery to ensure the tissue is not contaminated. Medtronic is an accredited member of the AATB since 1990. AATB is a voluntary organisation that sets standards for safety, quality, and availability of donated tissue. Our validated, proprietary processing methods meet or exceed all AATB and FDA regulations. A doctor may use these products alone or in combination with another graft material.

The medical and social screening process for donors whose tissue is recovered for processing is conducted in accordance with AATB standards, FDA regulations, and applicable Public Health Service Guidelines for donor screening. The FDA and AATB have oversight inspection of our establishment and practices. Sterile surgical techniques are used when recovering and processing donor tissue (free of microorganism like a bacteria, fungus or virus that can cause a disease).

When the tissue is recovered, samples are obtained and evaluated to ensure the tissue does not contain certain bacteria and microorganisms. Testing for infectious diseases is also performed. Some of these key tests include, but are not limited to, screening for HIV-1, HIV-2, Hepatitis B, Hepatitis C, and Syphilis. All testing is done under AATB and FDA guidelines. 

THE RISK ASSOCIATED WITH ALLOGRAFT

The risk of transmitting a disease from a screened tissue implant is 1 in over 1.5 million.¹  The risk rapidly decreases if the allograft is demineralised.²  For example, the risk of transmitting HIV from Medtronic’s Grafton DBM is significantly lower than transmitting HIV from a blood transfusion.³  Any tissue that tests positive for any of the above diseases is immediately declined for processing, and is not used.