Safety and efficacy of use of demineralised bone matrix in orthopaedic and trauma surgery

Abstract

Demineralised bone matrix (DBM) acts as an osteoconductive, and possibly as an osteoinductive, material. It is widely used in orthopaedic, neurosurgical, plastic and dental areas. More than 500,000 bone grafting procedures with DBM are performed annually in the US. It does not offer structural support, but it is well suited for filling bone defects and cavities. The osteoinductive nature of DBM is presumably attributed to the presence of matrix-associated bone morphogenetic proteins (BMPs) and growth factors, which are made available to the host environment by the demineralisation process. Clinical results have not been uniformly favourable; however, a variable clinical response is attributed partly to nonuniform processing methods found among numerous bone banks and commercial suppliers. DBMs remain reasonably safe and effective products. The ultimate safe bone-graft substitute, one that is osteoconductive, osteoinductive, osteogenic and mechanically strong, remains elusive.

Bone Regeneration Based on Tissue Engineering Conceptions — A 21st Century Perspective

“…Currently used BSM can be classified into different subgroups according to their origin (76, 81): 1) BSM of natural origin This group consists of harvested autogenous bone grafts as well as allogenic BSM, such demineralised bone matrix, corticocancellous or cortical grafts, cancellous chips (from either cadavers or living donors) (82)(83)(84). Xenogenic materials, for example porous natural bone hydroxyapatite from animal bones (bovine, equine, porcine etc.)…”

Improved physical and osteoinductive properties of demineralized bone matrix by gelatin methacryloyl formulation

“…Oakes and co‐workers tested the regenerative potential of different HA and Gly DBM formulations on rat's femur defects and showed an improved bone area repaired with HA compared with Gly formulation (Oakes et al, ). Despite Gly has been recognized as safe by the FDA (2) and is widely used as an excipient in multiple products, it exists a general conception to consider it questionable in an orthopaedic setting (Dinopoulos & Giannoudis, ). It is known that Gly in high doses results toxic when it is formulated with DBM and implanted in animal models (Bostrom et al, ; Wang et al, ).…”

Bioactive Scaffolds for the Controlled Formation of Complex Skeletal Tissues

“…Demineralized bone matrix is prepared by acid extraction of allograft bone (Urist, 1965). It results in the elimination of the major part of the mineral phase and the immunogenic components of bone, but retains collagen that provides a structured osteoconductive scaffold and a soluble protein fraction comprising several GFs, BMPs among them (Dinopoulos & Giannoudis, 2006;Reddi, 1998). It is also usual to retain a very low fraction of mineral bone phase after the demineralization step (2% approx.).…”

“…DBM by itself is presented in the form of a powder, but is usually mixed with other suitable materials (e.g. hyaluronan, poloxamer) to form a paste that can be easily casted at the bone defect site (Dinopoulos & Giannoudis, 2006;Juang Ming Yee et al, 2003). Mixing DBM with other materials, however, changes the product from a regulatory perspective.…”