Percutaneous Treatment Of Fracture Non-Unions Or Bone Defects With Autologous Bone Marrow With Demineralized Bone Matrix (Dbm)

The standard treatment of problem fractures or osseous defects has been an autologous cancellous bone graft harvested from the iliac crest. Limitations of this approach include morbidity at the graft site and the lack of adequate bone stock in some patients. Autologous bone graft is considered the gold standard because it includes components of all 3 processes considered to be essential for bone healing: osteoconductivity (i.e., a support structure), osteoinductivity (i.e., ability of graft to induce nondifferentiated stem cells to differentiate into osteoblast) and osteogenic cells. Therefore, bone graft substitutes, used either alone or in combination are designed to reproduce these components. The extracellular bone matrix includes a wide range of bone growth factors, proteins, and other bioactive materials necessary for osteoinduction. These factors can be removed from allograft bone by using a demineralizing agent, resulting in demineralized bone matrix (DBM). Several different preparations of DBM are commercially available, including putty, gel, and paste, which can be used as an adjunct to a variety of open surgical procedures. In contrast, the Ignite™ ICS product consists of a DBM that is designed to be injectable, thus enabling percutaneous treatment. Autologous bone marrow aspirate is designed to provide marrow stromal cells and osteogenic cells, and has been investigated as a stand-alone treatment of fracture, or in conjunction with demineralized bone marrow. The Ignite™ ICS product is specifically designed to be used in conjunction with bone marrow aspirate, and has the following labeled indication: “After the powder is mixed with autologous bone marrow aspirate, the resultant composite material can then be injected into the defect site. Ignite™ ICS is indicated only for bone voids or gaps that are not intrinsic to the stability of the bony structure. Ignite™ ICS is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.” Various different preparations of DBM are commercially available, regulated by the U.S. Food and Drug Administration (FDA) as either human tissue or cleared through the 510(k) marketing clearance process. An example of a DBM preparation that is regulated as a human tissue is Osteotech’s Grafton® and 3 preparations that have received 510(k) marketing clearance are the Wright Medical Allomatrix®, Exactech Resorbable Bone Paste, and DBX® from the Musculoskeletal Transplant Foundation. Bone morphogenetic protein (BMP) is another bone graft alternative and consists of a bioengineered equivalent of 1 of the components of bone matrix. Various BMP preparations have been FDA approved through the more rigorous PMA process, which does require evidence of clinical efficacy. BMP is discussed in MPRM Policy No.7.01.100. <a id="