Grafton DBM® Clinical Overview

Histologic analysis of implant sites after grafting with demineralized bone matrix putty and sheets.DP Callan, SL Salkeld, NL Scarborough. Implant Dent. 2000;9(1):36-42.

Grafting to restore lost alveolar bone is frequently used to enable placement of endosseous implants and improve cosmesis. Conflicting reports concerning the osteoinductivity of demineralized bone matrix (DBM) and historical use of synthetic bone graft substitutes has limited the use of DBM in oral and maxillofacial applications. Implant placement after bone grafting provides the unique opportunity to biopsy and histologically evaluate new bone formation. Bone grafting of the mandible or maxilla was performed to fill extraction sockets and restore ridge structures in a consecutive series of eight patients. DBM prepared as malleable putty (Grafton DBM Putty) or flexible sheets (Grafton DBM Flex) was used.

Biopsies were taken at re-entry, and histologic analysis determined the amount and quality of regenerated bone. Extensive new bone formation and minimal residual bone graft matrix were observed at an average of five months postoperative. The pattern of new bone maturity and remodeling varied by patient and the time in situ. Putty and Flex regenerated excellent bone height and width for the placement of dental implants, were easy to handle intraoperatively, and readily conformed to bony defects.

Histologic and clinical evaluation of an allogeneic bone matrix for the treatment of periodontal osseous defects. JT Mellonig.Int J Periodontics Restorative Dent. 2006;26(6):561-569.

The objective of this study was to evaluate the potential of an allogeneic bone matrix (Grafton,

Osteotech) to regenerate new bone, new cementum, and a new periodontal ligament around teeth previously contaminated by bacterial plaque. Four patients with chronic advanced periodontitis and who were scheduled for full-mouth extraction were enrolled in the study. One patient dropped out from the study before any therapy began. One tooth with an intraosseous defect in each patient was selected for treatment.

Measurements of probing depth, gingival recession, and clinical attachment level were made. After flap reflection, a root notch was placed at the apical level of calculus, the root was debrided, and allogenic bone matrix was inserted into the defect. After 6 months of healing, the teeth were removed en bloc and evaluated histologically for a new attachment apparatus. Two of the three teeth demonstrated regeneration of new bone, cementum, and periodontal ligament.

Long History of Usage and Performance

Comparative studies of sinus floor elevation with autologous or allogeneic bone tissue.NR Kübler, C Will, R Depprich, T Betz, E Reinhart, JS Bill, JF Reuther.Mund Kiefer Gesichtschir. 1999 May;3 Suppl 1:S53-60.

Klinik und Poliklinik für Mund-, Kiefer-, Gesichtschirurgie, Bayerische Julius-Maximilians-Universität Würzburg.

In 63 patients, 82 elevations of the maxillary sinus were performed. As augmentation, materials autografts from the iliac crest (combined with alveolar ridge augmentations in 16 sinus lifts) were transplanted in 39 cases and osteoinductive, allogeneic bone powder (AAA bone (autolyzed, antigen-extracted, allogeneic bone): n = 8, DFDBA (demineralized freeze-dried bone allograft) and/or Grafton (demineralized bone matrix gel): n = 35) were used in 43 cases. Some 4-6 months after implantation, osteoinductive, allogeneic (demineralized) bone implants showed radio-opaque areas as an equivalent of bone formation. Histological examinations revealed that osteoinductive implants were completely transformed into patients’ own bone tissue. The average augmentation height after autograft transplantations was 14 (+/- 3) mm in comparison with 9 (+/- 3) mm after allograft implantations. Histologically as well as radiologically no differences of the bone quality could be determined between the two augmentation materials. Endoscopic controls showed, in both groups, nonirritated mucous membranes. On an average 2 endosseous implants (Bone Lock or ITI-screw implants) were inserted into the augmentated maxillary sinus floors in both groups. No osseointegration was achieved in 4 out of 67 dental implants when bone autografts were used and in 2 out of 74 dental implants of the allogeneic bone group. Patients with bone autografts suffered from postoperative complaints on an average of 19 (+/- 9) days (without consideration of 2 patients with postoperative complaints persisting for more than 90 days). The average postoperative complaints of recipients of allogeneic bone implants continued for 3 (+/- 5) days. The 13 patients who underwent an ambulant sinus lift procedure with allogeneic bone powder were already symptom-free several hours after the operation. Under critical consideration of all investigated parameters, osteoinductive bone implants are preferable to iliac bone autografts for maxillary sinus augmentations in those cases in which no additional alveolar ridge augmentation is required.

Bone replacement grafts for the treatment of periodontal intrabony defects.PJ Hanes. Oral Maxillofac Surg Clin North Am. 2007 Nov;19(4):499-512, vi.

Department of Periodontics, Medical College of Georgia, School of Dentistry, 1459 Laney Walker Boulevard, Augusta, GA 30912-1220,

USA. phanes@mail.mcg.edu

Bone replacement grafts, including autogenous grafts from intraoral donor sites, allografts, xenografts, and alloplastic bone substitutes, are the most widely used treatment modalities for the regeneration of periodontal osseous defects. Studies suggest a favorable clinical outcome with the use of these materials in terms of improvements in periodontal probing depths, probing attachment gains, and bone fill. In terms of bone fill, most studies report more than 50% resolution of intrabony defects when treated with bone replacement grafts. However, histologic evidence of periodontal regeneration, including new bone, periodontal ligament, and cementum, has been reported only for autogenous bone grafts and demineralized freeze-dried bone allografts.

Long History of Usage and Performance

Application of demineralized human bone matrix in the surgical dental fusion treatment. Report of a case.OA Mora-Rincones, JC Corona-Rodríguez, AL Díaz-Carvajal, IC Franco-Carrero. Invest Clin. 2008 Jun;49(2):239-49.

Unidad de Cirugía Bucal y Maxilofacial, Centro Médico Dr. Rafael Guerra Méndez, Valencia, Venezuela. oscarkatty@cantv.net

The purpose of this work is to present a surgical alternative in the treatment of the dental fusions through the placement of demineralized human bone matrix (DHBM) (Grafton Putty), immediately after the separation and extraction of the fused tooth to the permanent one. The dental fusion is a dental anomaly of union, that consists in the union of two dental germs during development. It could happen at any of the dental germ evolution stages from the dental sheet or from more advanced processes of differentiation. For the clinical treatment, an allograft of DHBM with osteoinductive and osteoconductive properties was used. This had several factors of bone growth, it allowed the gradual growth of a new bone that helped to correct the bone defects post-extraction and to cover the exposed distal wall of the remaining permanent tooth. The clinic evaluation and the periapical and panoramic radiographies images were used for the clinical control. It can be concluded that the surgical separation and the extraction of the tooth with less anatomical likeness to the contralateral and the placement of the DHBM, represent a surgical treatment alternative of the dental fusion.

Versatility of Applications

Bone formation using human demineralised bone matrix (Grafton) for the treatment of bone cysts in children. HJ Hass, H Krause, S Kroker, W Wagemann, F Meyer. Eur J Pediatr Surg. 2007 Feb;17(1):45-9.

Department of Pediatric Surgery, University Hospital, Magdeburg, Germany. hans-juergen.hass@medizin.uni-magdeburg.de

Bone cysts, in particular solitary bone cysts, are the most frequent cause of pathological fractures in children. However, there is still a great variety of regimens used to treat these lesions. Since demineralised bone matrix (DBM) is commercially available, we aimed to use this material for the consolidation of bones diagnosed as fragile because of cyst formation. Each of the 7 bone cysts as well as one enchondroma filled with DBM showed a continuous decrease in bone transparency over a period of two years (mean 8 months). A significant decrease in bone transparency and simultaneous cortical remodelling was radiographically detected in these cases as the specific hallmark of an initiated graft incorporation after 3 to 4 months. It was demonstrated that it is possible to heal children within an acceptable period of time using DBM to fill the cystic lesion. DBM appears to be a reasonable and beneficial alternative for the treatment of bone cysts offering both osteoinduction and osteoconductive features.

Long History of Usage and Performance

Two-year fusion rate equivalency between Grafton DBM gel and autograft in posterolateral spine fusion: a prospective controlled trial employing a side-by-side comparison in the same patient. FP Jr Cammisa, G Lowery, SR Garfin, FH Geisler, PM Klara, RA McGuire, WR Sassard, H Stubbs, JE Block. Spine. 2004 Mar 15;29(6):660-6.

Hospital for Special Surgery, New York, New York, USA.

STUDY DESIGN: Multicenter, prospective equivalency trial with each patient serving as his/her own control. OBJECTIVES: To compare the effectiveness of a Grafton DBM gel composite with iliac crest autograft in posterolateral spine fusion. SUMMARY OF BACKGROUND DATA: While autograft remains the preferred graft material to facilitate spine fusion, the supply is limited and harvesting produces undesirable clinical consequences. METHODS: A total of 120 patients underwent posterolateral spine fusion with pedicle screw fixation and bone grafting. Iliac crest autograft was implanted on one side of the spine and a Grafton DBM/autograft composite was implanted on the contralateral side in the same patient. An independent, blinded reviewer evaluated anteroposterior and lateral flexion-extension radiographs. The fusion mass lateral to the instrumentation on each side was judged fused or not, and the mineralization of the graft was rated absent, mild, moderate, or extensive. The degree of correspondence in outcomes between sides was estimated by computing the percentage agreement and kappa statistic. RESULTS: Nearly 70% of patients (81 of 120) provided complete 24-month radiographic studies. The bone graft mass was fused in 42 cases (52%) on the Grafton DBMside and in 44 cases (54%) on the autograft side. The overall percentage agreement for fusion status between sides was approximately 75% (61 of 81), indicating moderately strong statistical correspondence (kappa = 0.51, P < 0.0001). Bone mineralization ratings also were similar between treated sides. Perfect agreement was realized in almost 60% of patients (48 of 81) with moderate statistical correspondence (weighted kappa = 0.54, P < 0.0001). CONCLUSIONS: Grafton DBM can extend a smaller quantity of autograft than is normally required to achieve a solid spinal arthrodesis. Consequently, a reduced amount of harvested autograft may be required, potentially diminishing the risk and severity of donor site complications.

Grafting long bone fractures with demineralized bone matrix putty enriched with bone marrow: pilot findings.RW Lindsey, GW Wood, KK Sadasivian, HA Stubbs, JE Block. Orthopedics. 2006 Oct;29(10):939-41.

Department of Orthopedic Surgery, Baylor College of Medicine, Houston, Tex, USA.

In this pilot study, the preliminary effectiveness of a composite graft consisting of demineralized bone matrix (DBM) putty (Grafton DBM) and aspirated bone marrow was evaluated for treating long bone fractures. Patients were ssigned randomly to treatment with the DBM putty composite (n = 10) or iliac crest autograft (n = 8), and had a minimum of 12 months of radiographic follow-up. Ninety percent of DBM patients (9/10) achieved full bone formation compared to 75% of autograft patients (6/8) (P = .41). Additionally, all 10 DBM patients were healed compared with 63% of autograft patients (5/8) (P = .07). These findings suggest that DBM putty enriched with bone marrow may be comparable to autograft for treating long bone fractures.

Versatility of Applications

Excellent Performance Across Species

Evidence of osteoinduction by Grafton demineralized bone matrix in nonhuman primate spinal fusion.J Louis-Ugbo, H Murakami, HS Kim, A Minamide, SD Boden.Spine. 2004 Feb 15;29(4):360-6; discussion Z1.

Medicine, The Atlanta Veterans Administration Medical Center, Atlanta, Georgia, USA.

STUDY DESIGN: A nonhuman primate posterolateral lumbar intertransverse process arthrodesis model was used to evaluate osteoinductive bone graft materials. OBJECTIVES: To test two new formulations of Grafton demineralized bone matrix (Flex and Matrix) for evidence of osteoinduction and their potential efficacy as an extender or enhancer for autogenous bone in a previously validated nonhuman primate posterolateral lumbar fusion model. SUMMARY OF BACKGROUND DATA: Whereas several demineralized bone matrix formulations have been shown to be variably osteoinductive in rodent ectopic bone assays and rabbit spine applications, few have demonstrated efficacy in higher species and in more challenging applications such as posterolateral spine fusion. The authors are not aware of any published studies describing any demineralized bone matrix that has been tested in a nonhuman primate posterolateral spine fusion model. METHODS: After approval by the institutional animal care and use committee, eight skeletally mature rhesus macaques underwent single-level posterolateral arthrodesis. In four animals, autograft (4 g/side) was implanted with a piece of human Grafton Flex demineralized bone matrix. In the other four animals, rhesus Grafton Matrix demineralized bone matrix, a new and more porous formulation of Flex, was implanted with autograft (4 g) on one side of the spine, and Matrix with half the amount of autograft (2 g) was implanted on the opposite side. Radiographs were taken at intervals until the animals were killed at 24 weeks. Spinal fusion was evaluated by manual palpation (status was fused or not fused), and computed tomography was done to visualize the amount of bone formation. RESULTS: Fusion was ascertained by palpation in two of four monkeys receiving Flex with autograft and in three of four monkeys receiving Matrix with autograft. Evidence of osteoinduction was seen in all four monkeys on the Matrix with 4 g autograft side, which had larger fusion masses than in the other treatments. Histologic examination showed that the bone formed was normal. CONCLUSIONS: The rhesus Matrix formulation performed better than the human Flex. Evidence of osteoinduction was seen in all four monkeys that received Matrix, which improved the fusion success of autograft. This alone suggested that it might play a role as a graft enhancer, not merely as a graft extender. Human studies are warranted.

New formulations of demineralized bone matrix as a more effective graft alternative in experimental posterolateral lumbar spine arthrodesis.GJ Martin Jr., SD Boden, L Titus, NL Scarborough.Spine. 1999; 24(7):637-645.

The objective of this study was to determine the efficacy of two new formulations of demineralized bone matrix in an animal model. The flowable gel form of Grafton (Osteotech, Eatontown, NJ) demineralized bone matrix has been shown to have osteoinductive properties in various models and currently is used clinically as bone graft material in posterolateral lumbar spine arthrodesis. Two new formulations of Grafton, one made of flexible sheets (Flex) and the other made in a malleable consistency (Putty), have improved handling characteristics compared with the gel form.

Posterolateral intertransverse process athrodesis was performed on 108 skeletally mature New Zealand white rabbits using corticocancellous bone graft harvested from the iliac crest and/or DBM of various formulations. The new flexible sheet and malleable putty forms of demineralized bone matrix were effective as graft extender and graft enhancer in a well-characterized rabbit model of posterolateral lumbar spine fusion. The malleable putty form and flexible sheet form were able to function as a complete graft substitute, with the latter performing superiorly in this challenging animal spine fusion model. These newer formulations of Grafton appear to have a greater capacity to form bone through osteoconductive pathways than the original gel form or autogenous bone graft alone in the rabbit.

Induction of bone by a demineralized bone matrix gel: A study in a rat femoral defect model.JE Feighan, D Davy, AB Prewett, S Stevenson. J Orthopaed Res. 1995;13(6):881-891.

Demineralized bone matrix contains osteoinductive factors and stimulates filling of gaps and defects with bone; however, it is difficult to handle by itself and various preparations have been tested. Demineralized bone matrix with a gel consistency is now available for clinical use. We studied, in a femoral segment defect in the rat, the effects of rat demineralized bone matrix gel with and without ceramic substratum. This preparation is analogous to the human demineralized bone matrix in the same carrier, used clinically for humans.

One hundred adult male Fischer rats were divided into 10 experimental groups. Independent variables including the presence or absence of hydroxyapatite ceramic cylinders, the presence of demineralized bone matrix in carrier or carrier alone (glycerol), and the duration of observation (1,2, and 4 months). Defects filled with the gel alone had significantly higher radiographic scores for host-graft union at 4 months, compared with ceramic with the gel, ceramic alone, or carrier alone.

Demineralized bone matrix gel significantly increased the total histologic score for host-graft union, whether ceramic was present or not, and a three-way interaction occurred among ceramic, the gel, and time. Demineralized bone matrix gel was an effective inducer of new bone in this model. An additional substratum was not required; in fact, significantly more bone was formed in the absence of the ceramic cylinder. Neither the gel, nor the ceramic were impediments to revascularization of the defect. Host-graft union was enhanced by demineralized bone matrix gel but not by the ceramic cylinder.

Excellent Performance Across Species

In a Class of its Own

A comparative review of the osteoinductivity of four formulations of allogeneic demineralized bone matrix.TB Aufdemorte, TW Bauer.University of Texas of San Antonio, San Antonio, TX. and The Cleveland Clinic Foundation, Cleveland, OH. WP54 09/15/99

When properly processed, demineralized bone matrix (DBM) graft materials can take advantage of two healing pathways or mechanisms. First, DBM allografts can provide a suitable matrix for cells to infiltrate, populate and produce new bone through “osteoconductive” healing. DBM can also aid in the healing response through “osteoinductive” pathways in which mesenchymal cells are stimulated by native bioactive molecules to differentiate into bone forming cells. Demineralization is a necessary process to produce a bone allograft with osteoinductive capabilities. However, not all demineralization processes effectively or consistently produce osteoinductive allografts. Some tissue processing techniques can affect both the presence and robustness of the osteoinductive capacity of the resulting demineralized end product.

This review examines the osteoinductivity of four formulations of human DBM from three tissue-processing facilities. These studies utilized a well-characterized athymic rat model comparing the osteoinductive potential of Osteofil® (Regeneration Technologies Inc., Alachua, FL.), Dynagraft® (GenSci Regeneration Sciences Inc., Toronto, Canada) and Grafton® DBM (Osteotech Inc., Eatontown, NJ).

Both the Putty and Gel formulations of Grafton consistently showed a strong osteoinductive response via the anticipated pathway of endochronal bone formation. In contrast, Osteofil showed osteoinductive activity, but produced less cartilage (14 days) and bone (28 days) than an equivalent volume of Grafton. DynaGraft failed to show consistent osteoinduction. The inability of a material to form new bone in this animal model has been shown to have a negative effect on bone healing. A material that elicits an osteoinductive response is more likely to lead to a satisfactory clinical outcome.

Osteogenic activity of OP-1 bone morphogenetic protein (BMP-7) in a human fibular defect.RGT Geesink, NHM Hoefnagels, SK Bulstra. J Bone Joint Surg Br. 1999;81(4):710-718.

This study is a prospective, randomized double-blind study in 24 patients undergoing high tibial osteotomy to evaluate the effectiveness of human recombinant osteogenic protein (OP-1) on a collagen type-1 carrier in a critically-sized fibular defect. The study had two phases, each evaluated by clinical, radiological, and DEXA methods during the first postoperative year. The first concerned the validation of the model of the fibular defect, using positive (Grafton DBM) and negative (untreated) controls. The second phase concerned the osteogenic potential of OP-1 on collagen type-I vs. collagen type-I alone.

The results of the first phase established the critically-sized nature of the defect. In the untreated group, no bony changes were observed while, in the Grafton DBM bone group, formation of new bone was visible from six weeks onwards. The results of the second phase showed no significant formation of new bone in the presence of collagen alone, while in the OP-1 group, all patients except one showed formation of new bone from six weeks onwards. This provided the osteogenic activity of OP-1 in a validated critically-sized human defect.

Osteoinductivity of commercially available demineralized bone matrix: preparations in a spine fusion model.B Peterson, PG Whang, R Inglesias, JC Wang, JR Lieberman. J Bone Joint Surg Am. 2004;86A(10):2243-2250.

Background: Although autogenous bone is the most widely used graft material for spinal fusion, demineralized bone matrix preparations are available as alternatives or supplements to autograft. They are prepared by acid extraction of most of the mineralized component, with retention of the collagen and noncollagenous proteins, including growth factors. Differences in allograft processing methods among suppliers might yield products with different osteoinductive activities. The purpose of this study was to compare the efficacy of three different commercially available demineralized bone matrix products for inducing spinal fusion in an athymic rat model.

Methods: Sixty male athymic rats underwent spinal fusion and were divided into three groups of eighteen animals each. Group I received Grafton Putty; Group II, DBX Putty; and Group Ill, AlloMatrix Injectable Putty. A control group of six animals (Group IV) underwent decortication alone. Six animals from each of the three experimental groups were killed at each of three intervals (two, four, and eight weeks), and the six animals from the control group were killed at eight weeks. At each of the time-points, radiographic and histologic analysis and manual testing of the explanted spines were performed.

Results: The spines in Group I demonstrated higher rates of radiographically evident fusion at eight weeks than did the spines in Group III or Group IV (p < 0.05). Manual testing of the spines at four weeks revealed variable fusion rates (five of six in Group I, two of six in Group II, and none of six in Group Ill). At eight weeks, all six spines in Group I, three of the six in Group II, and no spine in Group III or IV had fused. Histologic analysis of the spines in Groups I, II, and III demonstrated varying amounts of residual demineralized bone matrix and new bone formation. Group-1 spines demonstrated the most new bone formation.

Conclusions: This study demonstrated differences in the osteoinductive potentials of commercially available demineralized bone matrices in this animal model.

Clinical Relevance: Comparative clinical testing of demineralized bone matrices is indicated in order to determine which preparations are best suited for promoting successful spinal fusion in humans.

In a Class of its Own

A comparison of commercially available demineralized bone matrix for spinal fusion.JC Wang, A Alanay, LE Kanim, PA Campbell, EG Dawson, JR Lieberman. Eur Spine J. 2007;16(8):1233-1240.

Department of Orthopaedics and Traumatology, UCLA School of Medicine, Los Angeles, CA 90024, USA.

In an effort to augment the available grafting material as well as to increase spinal fusion rates, the utilization of a demineralized bone matrix (DBM) as a graft extender or replacement is common. There are several commercially available DBM substances available for use in spinal surgery, each with different amounts of DBM containing osteoinductive proteins. Each product may have different osteoinductivity potential due to different methods of preparation, storage, and donor specifications. The purpose of this study is to prospectively compare the osteoinductive potential of three different commercially available DBM substances in an athymic rodent spinal fusion model and to discuss the reasons of the variability in osteoinductivity. A posterolateral fusion was performed in 72 mature athymic nude female rats. Three groups of 18 rats were implanted with 1 of 3 DBMs (Osteofil, Grafton, and Dynagraft). A fourth group was implanted with rodent autogenous iliac crest bone graft. The rats were sacrificed at 2, 4, 6, and 8 weeks. A dose of 0.3 cm(3) per side (0.6 cm(3)per animal) was used for each substance. Radiographs were taken at 2 weeks intervals until sacrifice. Fusion was determined by radiographs, manual palpation, and histological analysis. The Osteofil substance had the highest overall fusion rate (14/18), and the highest early 4 weeks fusion rate of (4/5). Grafton produced slightly lower fusion rates of (11/17) overall, and lower early 4 weeks fusion rate of (2/5). There was no statistically significant difference between the rate of fusion after implantation of Osteofil and Grafton. None of the sites implanted with Dynagraft fused at any time point (0/17), and there was a significantly lower fusion rate between the Dynagraft and the other two substances at the six-week-time point and for final fusion rate (P = 0.0001, Fischer’s exact test). None of the autogenous iliac crest animals fused at any time point. Non-decalcified histology confirmed the presence of a pseudarthrosis or the presence of a solid fusion, and the results were highly correlated with the manual testing. Although all products claim to have significant osteoinductive capabilities, this study demonstrates that there are significant differences between some of the tested products.

In a Class of its Own

Allograft safety: Viral inactivation with bone demineralization.NL Scarborough, EM White, JV Hughes, AJ Manrique, JW Poser. Contemp Orthop. 1995;31(4):257-261.

A study was performed to validate the effectiveness of a bone demineralization process with respect to its inactivation of viruses. The viruses selected for study included human immunodeficiency virus (HIV), duck hepatitis B virus (a model for human hepatitis B), bovine viral diarrheal virus (a model for human hepatitis C), human cytomegalovirus, and human poliovirus (a model for small nonenveloped viruses, e.g., hepatitis A).

This study was performed in compliance with Good Laboratory Practice regulations using validation methodology similar to that used to ensure the safety of blood derivatives and other products. Use of the bone demineralization process described in this report resulted in a reduction in infectivity of greater than one million (106) for all viruses and as much as one trillion (1012) for the poliovirus.

Safety

Tissue banking of bone allografts used in periodontal regeneration.Committee on Research, Science and Therapy, of the American Academy of Periodontology.J Periodontol. 2001;72(6):834-838.

This review paper evaluated the current knowledge of the safety and effectiveness of bone allograft materials, including demineralized freeze-dried bone allograft (DFDBA). Bone allografts have been widely used in periodontal therapy and continue to be used in contemporary clinical practice. Most bone banks adhere to the guidelines of the American Association of Tissue Banks (AATB) with respect to procurement, processing and sterilization of bone grafts. There have been no reports of viral contamination or acquired pathology from DFDBA, and thus, DFDBA appears to be safe from disease transmission.

Clinical results using DFDBA have been variable based on evidence from clinical reports due to the wide variability in bone graft processing. Factors such as terminal sterilization of the bone allograft material, processing methods, and donor age influence the bone inductive ability of DFDBA.

The only definitive assay of osteoinduction remains implantation of the DFDBA in a tissue that otherwise would not form bone, such as an immunodeficient rat or mouse muscle. A quantitative histologic analysis must be performed of the amount of new bone that is formed in association with the implanted DFDBA. In vitro assays used to assess bone induction ability must be relied on with caution.

Editor’s Note: Grafton DBM is procured and processed by AATB-compliant tissue banks. Grafton DBM is one of the few products that has demonstrated to be consistently osteoinductive according to the guidelines suggested in the article.

In a Class of its Own

As applicable, BioHorizons products are cleared for sale in the European Union under the EU Medical Device Directive 93/42/EEC. We are proud to be registered to ISO 13485:2003, the international quality management system standard for medical devices, which supports and

maintains our product licences with Health Canada and in other markets around the globe.

© 2008 BioHorizons Implant Systems, Inc. All Rights Reserved. MLD207 REV A OCT 2008

Grafton DBM is a registered trademark of Osteotech, Inc. Grafton DBM is not available in all countries.

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