Types of Bone Graft Substitutes

by David L. Nelson, MD

(last updated 11/21/99)

We are in the process of updating it so that the company name is a hyperlink to additional text material on the company's product, and the product name is a hyperlink to histology photographs and xrays of cases. If your company has not yet submitted additional material for inclusion in this paper, please contact the Webmaster.

Demineralized Bone Matrix (Allografts)
This group of products contains human bone matrix proteins that are osteoinductive. Some contain particles of whole bone, which are osteoconductive.
Product	Company	Nature of Material	Advantages	Disadvantages	Cost (11/98)
Grafton DBM	Osteotech/Am. Red Cross	demineralized allograft		disease transmission (? real)	$300/2.5 cc $546/5.0 cc
Dynagraft	DePuy/GenSci Regeneration	demineralized allograft		disease transmission (? real)	putty: $225/2.5 cc $415/5.0 cc gel: $395/5.0 cc matrix: $205/2x2 cm
AlloGro	AlloSource	demineralized allograft		disease transmission (? real)	not known
Opteform	Exactech	demineralized allograft	the carrier for this product is formable in warm water but solid at body temperature	disease transmission (? real)	not known
Note: These products have not been approved by the FDA, since human-derived materials are not covered by the FDA legislative mandate. They are regulated the way blood for transfusion is regulated, and is quite different.
Mineral
This group of products contain materials that are similar to the mineral phase of bone and are osetoconductive. They are not osteoinductive.
Product	Company	Nature of Material	Advantages	Disadvantages	Cost (11/98)
ProOsteon 500R	Interpore Int'l	coraline hydroxyapetite	some structural strength remodels faster than the original 500 (500R has less of the calcium carbonate changed into calcium phosphate)		block: $160/1.0 cc $319/2.4 cc $512/4.0cc $986/10.0cc granules: $211/5.0 cc $390/10.0cc $5575/20cc
OsteoSet	Wright Biomedical	highly purified plaster of paris	very fast remodelling very rapid bone formation	no structural strength	3.0 mm or 4.8 mm pellets $225/5.0 cc $320/10.0cc $510/20cc $1280/50cc
Stimulan	Encore Orthopedics	calcium sulfate bone void filler, medical grade calcium sulfate dihydrate and stearic acid	no data yet	no data yet	no data yet
Mineral Cements
Product	Company	Nature of Material	Advantages	Disadvantages	Cost (11/98)
SRS	Norian	carbonated apetite	first on the market supplements internal fixation will be available very soon; cleared by FDA	collapses without supplementary support	not priced as of 1/15/99 in USA
BoneSource	Stryker/Howmedica	carbonated apetite	not yet available probably more similar to Norian SRS than to anything else	not sufficient data released in Europe	not priced as of 1/15/99 in USA
alpha-BSM	Etex	carbonated apetite	not yet available resorbs much faster than Norian SRS	not sufficient data released in Europe	not priced as of 1/15/99 in USA
Mineral & Other Components
Product	Company	Nature of Material	Advantages	Disadvantages	Cost (11/98)
Collagraft	Zimmer	ultrapurified bovine collagen + tricalcium phosphate + hydroxyapetite	easily mixes with host bone	no structural strength	$241/1strip $593/3strips $991/6strips
Healos	Orquest	collagen + hydroxyapetite porous sponge- like material made from hydroxyapatite-coated collagen fibers		in early development	not yet priced
Mineral &/Or Cytokines*
Product	Company	Nature of Material	Advantages	Disadvantages	Cost (11/98)
rh-BMP-2	SofamoreDanek/ Genetics Institute	recombinant human BMP-2		in early development
Novos	Stryker/Creative Biomolecules	bovine collagen + OP-1 (BMP-7)		in early development
Ossigel	Orquest	bFGF in hyaluronic acid		in early development
Matrix Inductor	IsoTis BV			in early development
TGF-beta-1	DePuy/Genetech	TGF-beta-1		in early development
Ne-Osteo	Sulzer Orthopedics Biologics			in early development

Other (Do not fit into above categories)
Product	Company	Nature of Material	Advantages	Disadvantages	Cost (11/98)
Immix	OsteoBiologics	PLA/PGA	material is quite new, no data yet available		unknown

Note: Great effort was expended to verify these data; any corrections or omissions should be sent to the Webmaster. The price data shown above was that actually charged to my hospital, or if not carried, quoted directly from the manufacturer or their representative.

* Cytokines are bioactive proteins that act on cells adjacent to the cell where is it elaborated. The best known cytokine is BMP, discovered by Marshall Urist in 1964. They have great potential for helping many conditions in orthopedics. They simultaneously have great potential for problems, and the FDA has set up a special review process to ensure the safety and efficacy of these products. The author is not aware of any cytokine being released to the market.

The field of bone graft substitutes is changing rapidly, even more rapidly than a Website can keep up with. Letters have been sent to the various manufacturers requesting that updates be sent to the Webmaster, and will be incorporated as quickly as possible into this section. The various advantages and disadvantages listed are quite relative to the intended use. For example, in bone grafting the spine, the fact that there is no structural strength is not a disadvantage, while it might be in grafting a distal radial fracture. The purpose of this section is to draw information from many sources and present it in one place in a uniform format, so that the individual surgeon can start to make informed choices. Obviously, much has been omitted in order to fit this table; the surgeon is advised to learn more about each material before using it.

We expect to soon have a Discussion Group capability added to the site, which will allow surgeons to discuss their experience. This should be a great help to surgeons in some countries, if the product has extensive exposure in other countries.