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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.

 
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