Studies
Grafton DBM has been shown to outperform competitive DBM products. In a study funded by the Musculoskeletal Transplant Foundation (MTF)(5), researchers at UCLA used the athymic rat spine model to show that Grafton DBM fused 100% of recipients, versus a 50% fusion rate in those treated with DBX and a 0% fusion rate for those treated with Allomatrix.| Data on File. 04-007A Summary Report Osteoinduction of Competitor Materials in the Athymic Rat. Grafton DBM as compared to the osteoinductivity of Osteofil, Dynagraft II, Allomatrix, DBX, Accell DBM 100, Intergro DBM, and Orthoblast II, when measured in the athymic rat. | ||
Osteotech's internal R&D study is consistent with the results of the UCLA study, showing a high degree of variability from lot-to-lot with DBX.(2)
| Performance in this model is not a predictor of clinical performance. | ||
| B Peterson, MD, et al. "Osteoinductivity of Commercially Available Demineralized Bone Matrix: Preparations in a Spine Fusion Model. Journal of Bone & Joint Surgery, October 2004, 86-A No. 10. |
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In addition to the athymic rat, more challenging models also demonstrate the promising results of Grafton DBM(6)
| J Louis-Ugbo, SD Boden, et al. "Evidence of Osteoinduction by Grafton® Demineralized Bone Matrix in Nonhuman Primate Spinal Fusion" SPINE Volume 29, No 4. February, 2004. | ||
, which is shown to be effective in:
| Martin, G.J., Boden, S.D., Titus, L., and Scarborough, N.L.: New Formulations of Demineralized Bone Matrix as a More Effective Graft Alternative in Experimental Posterolateral Lumbar Spine Arthodesis. Spine 24 (7):637. 1999. | ||
- Rabbit, and primate models (3),(8)
W Sassard, et al. "Augmenting Local Bone with Grafton® Demineralized Bone Matrix for Posterolateral Lumbar Spine Fusion: Avoiding Second Site Autologous Bone Harvest"
Orthopedics 2000, Vol. 23, No.10. - A retrospective clinical series(7)
FP Cammisa, et al "Two-Year Fusion Rate Equivalency Between Grafton® DBM Gel and Autograft in Posterolateral Spine Fusion". SPINE Volume 29, No 6. March 2004. J Kang, et al. "Grafton® & Local Bone Has Comparable Outcomes to Iliac Crest Bone in Single Level Lumbar Fusions" (WP122)
- Prospective randomized trials(9),(10)
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