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, allograft tissues can be used in different ways depending on how they're processed—mineralized allograft provides strength, while demineralized allograft fills bony voids instead of providing strength.

WHAT IS DEMINERALIZED BONE MATRIX?

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

Demineralized allografts (e.g., Grafton^TM, Magnifuse^TM 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 demineralization 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 “demineralized bone matrix,” or DBM, and are commonly used to fill bony voids throughout the skeletal system, and—unlike mineralized allografts—they do not provide strength.

HOW DOES ALLOGRAFT TISSUE WORK?

Allograft tissue works through a process called “osteoconduction.” Imagine a vine growing through and around a trellis. Allograft tissue works in a similar fashion. Allograft is like a scaffold (trellis) that supports the bone-forming cells (the vine) as they grow new bone over time. 

IS ALLOGRAFT TISSUE SAFE?

Your doctor uses tissue processed by one of the major suppliers of allograft tissue to the orthopedic, spinal, and dental markets. Medtronic only partners with reputable American Association of Tissue Banks (AATB)-accredited tissue banks. These tissue banks utilize 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 organization that sets standards for safety, quality, and availability of donated tissue. Our validated, proprietary processing methods meet or exceed all AATB and FDA regulations. Your 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 demineralized.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.

INDICATIONS FOR USE: GRAFTON dBM AND GRAFTON PLUS DBM

GRAFTON™ DBM and GRAFTON PLUS™ DBM are intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. GRAFTON™ DBM (excluding the Orthoblend form) and GRAFTON PLUS™ DBM are also intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral, and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. GRAFTON™ DBM and GRAFTON PLUS™ DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or they may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. GRAFTON™ DBM and GRAFTON PLUS™ DBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON™ DBM and GRAFTON PLUS™ DBM are absorbed/remodeled and replaced by host bone during the healing process. Note: The user should consider the fact that GRAFTON™ DBM CRUNCH contains demineralized bone chips approximately 3 mm (±1 mm) in determining the appropriateness of this allograft for use in small defects.

CAUTION

This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Caution should be exercised if the patient is allergic to these antibiotics or chemicals. GRAFTON PLUS™ DBM Paste contains starch. Therefore, caution should be exercised in using GRAFTON PLUS™ DBM Paste in a patient with a starch allergy and/or amylase deficiency.

PRECAUTIONS

Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. Despite the viral inactivation and extensive tissue donor selection and qualification processes used in providing this tissue graft, transmission of an infectious disease through the use of this tissue graft is still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially attributable to GRAFTON™ DBM or GRAFTON PLUS™ DBM must be reported promptly to Medtronic. Adequate fixation should be used to stabilize the implant site during bone formation and healing in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities). If injecting GRAFTON™ DBM or GRAFTON PLUS™ DBM into the defect site, precaution should be taken not to: 

• Over-pressurize the delivery device, as this may lead to extrusion of the device beyond the site of its intended application and damage to the surrounding tissues. 
• Over-pressurize the defect site, as this may lead to fat embolization or embolization of the device material into the bloodstream. 

When used as a bone graft extender in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities), GRAFTON PLUS™ DBM Paste is intended for use only with autograft, not other allograft. Recommended ratios of GRAFTON PLUS™ DBM Paste to autograft as a bone graft extender are 1:1 or 2:1.

CONTRAINDICATIONS

The following are contraindications for the use of GRAFTON™ DBM and GRAFTON PLUS™ DBM:

• The presence of infection at the transplantation site.
• Treatment of spinal insufficiency fractures.

INDICATIONS FOR USE: MAGNIFUSE BONE GRAFT

Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone.

Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile saline in order to adjust the consistency and handling characteristics of the bone graft material. Magnifuse™ Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

Magnifuse™ II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Magnifuse™ II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.

CONTRAINDICATIONS

The following are contraindications for the use of Magnifuse™ DBM Bone Graft and Magnifuse™ II Bone Graft:

• The presence of infection at the transplantation site.
• Treatment of spinal insufficiency fractures.

CAUTION

This product may contain trace amounts of antibiotics (gentamicin), surfactant, and other solutions used in processing the bone tissue as well as the PGA mesh. Caution should be exercised if the patient is allergic to these antibiotics or chemicals.

PRECAUTIONS

Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. Despite the viral inactivation and extensive tissue donor selection and qualifications process used in providing this tissue graft, transmission of an infectious disease through the use of this tissue graft is still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially attributable to Magnifuse™ or Magnifuse™ II Bone Graft must be reported promptly to Medtronic (i.e., spine, pelvis, and extremities). Adequate fixation should be used to stabilize the implant site during bone formation and healing in bony voids or gaps of the skeletal system.