GRAFTON EVIDENCE Bone Grafting (Spine and Orthopaedic)
Grafton™ demineralized bone matrix (DBM) is the most utilized and scientifically studied DBM brand.*† Below are overviews of just a few of the studies. For a more comprehensive summary of studies, refer to the List of Evidence: A historical review of performance.
Prospective Multicenter Randomized Study: Single-Level Posterolateral Fusion (PLF) Surgery
Kang et al. SPINE Volume 37, N°12, pp 1083-1091. 2012
At two-year follow up, Grafton Matrix achieved 86% overall fusion while ICGB saw 92% fusion (p=1.0).
The Grafton group showed slightly better improvement of ODI score and higher physical function score.
There was a significantly greater mean blood loss in the ICBG group than in the Grafton group (p < 0.0031).
At 2-year follow-up, subjects who were randomized to Grafton matrix plus local bone achieved an 86% overall fusion rate and improvements in clinical outcomes that were comparable with those in the ICBG group.
Single Level Rabbit Posterolateral Fusion Study
Martin G.J., et al. SPINE Volume 24, Nb 7, pp 637–645. 1999
Experimental rabbit (n = 108) posterolateral lumbar spine model three groups:
Each group was tested in the following proportion:
Single Center Prospective Study on Open or Closed Long Bone Fractures
Lindsey, R.W, et.al., Orthopedics, Oct 2006 Volume 29, Number 10, pp 939
Retrospective Review on Atrophic Ununited Fracture of the Humeral Diaphysis
Hierholzer, C. et al., JBJS, Vol 88-A, Nb 7, July 2006, pp1442-1447.
Union noted in 100% of autologous bone graft patients versus 97% in the Grafton flex group.
Mean time to union was 4.5 months (control) versus 4.2 months (Grafton flex).
Same functional outcome in both groups.
44% of control recipients had donor site pain.
Animal studies are not necessarily indicative of human clinical outcome.
Based on Pub-Med search on 8/26/14 with keywords Grafton DBX and Osteosponge.