Grafton™ demineralised bone matrix (DBM) is the most utilised and scientifically studied DBM brand.*† Below are overviews of just a few of the studies.
Preclinical
Grafton and local bone have comparable outcomes to Iliac crest bone instrumented single-level lumbar fusion
Prospective Multicenter Randomised Study: Single-Level Posterolateral Fusion (PLF) Surgery
Kang et al. SPINE Volume 37, N°12, pp 1083-1091. 2012
Two groups:
- 30 Grafton Matrix + local bone
- 16 iliac crest autograft alone (ICBG = control group)
Results
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).
Conclusion
At 2-year follow-up, subjects who were randomised 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.
Clinical evidence
Osteoinductivity of Commercially Available Demineralised Bone Matrix (DBM): Preparations in a Spine Fusion Model
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:
- Grafton gel (particles)
- Grafton putty (fibers)
- Grafton flex (fibers)
Each group was tested in the following proportion:
- 50% DBM/50% autograft
- 100% DBM
- Autograft control
Results
- In the 50/50 distribution group, fusion rates of Grafton Putty (100%) and Flex (100%) DBM were superior (p<0.01) to those of the autograft alone group (33%)
- As a stand-alone (100%) graft substitute, Grafton Flex demonstrated superior performance with a fusion rate of 100% compared with Putty (83%) and Gel (58%).
Demineralised Bone Matrix Composite Grafting
Grafting long bone fractures with DBM Putty enriched with bone marrow: pilot findings
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
- 10 patients Grafton putty plus BMA
- 8 patients iliac crest autograft alone (control group)
Results
- At 12-month follow up, 90% of Grafton patients (9/10) achieved full bone formation compared to 75% of autograft patients (6/8) (p = 0.41).
- All 10 Grafton patients were healed compared with 63% of autograft patients (5/8) (p = 0.07).
Plate Fixation of Ununited Humeral Shaft Fractures: Effect of Type of Bone Graft on Healing
Retrospective Review on Atrophic Ununited Fracture of the Humeral Diaphysis
Hierholzer, C. et al., JBJS, Vol 88-A, Nb 7, July 2006, pp1442-1447.
- 45 patients iliac crest autograft (control)
- 33 patients Grafton flex
Results
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.