GRAFTON EVIDENCE Bone Grafting (Spine and Orthopaedic)

PRECLINICAL AND CLINICAL EVIDENCE SUMMMARY

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.


PRECLINICAL

Grafton and Local Bone Have Comparable Outcomes to Iliac Crest Bone Instrumented Single-Level Lumbar Fusion

Prospective Multicenter Randomized 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).

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.

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).

There was 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 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.


CLINICAL EVIDENCE

Osteoinductivity of Commercially Available Demineralized 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%).

Demineralized 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).

Union noted in 100% of autologous bone graft patients vs. 97% in the Grafton Flex group.

Same functional outcome in both groups.

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.