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).

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 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).

Same functional outcome in both groups.

44% of control recipients had donor site pain.