What the Data Says

What the Data Says

Review the key studies on ACTIFUSE in more detail.

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How ACTIFUSE Works

How ACTIFUSE Works

The patented silicate substitution process facilitates natural bone remodeling.

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The ACTIFUSE Advantage

The ACTIFUSE Advantage

Comparison to Iliac Crest

ACTIFUSE has shown similar fusion rates in comparison to iliac crest in both a clinically relevant ovine PLF model*4 as well as in retrospective human study (vs historical controls).5

Comparison to Autograft
  • Quantitative CT demonstrates total fusion volume against time in a preclinical ovine PLF model.4
  • No statistical differences were detected between treatment groups (p<0.05). (n=9 per group)

An Efficacious Alternative to Autograft

  • ACTIFUSE has shown similar fusion rates in comparison to iliac crest in a retrospective human study (vs historical controls).5
  • ACTIFUSE may avoid the need for harvesting autograft. With iliac crest bone, there is a potential for poor material quality and limited graft volumes.6
  • Bone harvesting can be associated with pain and donor site morbidity.7
Distinctive and Versatile

The ACTIFUSE Portfolio Provides Surgeons With Delivery and Handling Options

  • Distinctive and versatile handling characteristics that support surgeon technique.
  • Sculptable consistency ensures an ability to address the unique contours of each defect.
  • Resistant to irrigation.8
The ACTIFUSE portfolio provides surgeons with delivery and handling options

The Distinctive Chemistry and Structure Enhances Bioactivity and Accelerates Bone Formation

  • Silicon is essential for normal bone development and both its presence and level in a bone graft can have a profound effect on the healing response.1,3
  • ACTIFUSE contains 0.8 weight% silicon which is proven to be optimal for accelerated bone formation.*1
  • The unique interconnected porous structure supports rapid bone formation and cellular infiltration.*1
  • ACTIFUSE is remodeled like human bone via osteoclastic resorption rather than dissolving at a fixed rate.*4

Increased Cell Attachment

Significantly more cells attach to ACTIFUSE than calcium phosphate.2

Increased Cell Attachment

  • In-vitro experiments were performed in triplicate, at least twice.
  • Cell attachment was measured on discs incubated with osteo-blast-like cells.
  • Cell attachment on ACTIFUSE was statistically significant compared to calcium phosphate at all time points until 90 minutes of incubation (p<0.001).2

Accelerated Bone Formation

In a preclinical model comparing ACTIFUSE to ß-TCP and dense calcium sulfate, ACTIFUSE treated animals had greater new normalized bone volume.3

  • Accelerated Bone FormationBGS samples were implanted into subchondral bone of the femoral condyle of New Zealand White rabbits, with surgically created defects (4.8 ± 0.3 mm diameter, 6–7 mm length).
  • The sample size was n=4 per BGS per time point.
  • Histomorphometry, using point counting, was used to determine the bone graft substitute volume.
  • The intertreatment comparison of mean levels of percentage normalized bone volume at specific time points showed consistently greater levels within ACTIFUSE-treated defects, reaching significance at 3 weeks (p<0.0001), 6 weeks (p<0.0001) and 12 weeks (p<0.05).3

Natural Remodeling and Graft Resorption

The resorption of ACTIFUSE is physiologically appropriate: Like human bone, ACTIFUSE is remodeled via osteoclasts and osteoblasts rather than dissolving.*3

  • Natural Remodeling and Graph ResorptionBGS samples were implanted into subchondral bone of the femoral condyle of New Zealand White rabbits, with surgically created defects (4.8 ± 0.3 mm diameter, 6–7 mm length).
  • The sample size was n=4 per BGS per time point.
  • Histomorphometry, using point counting, was used to determine the bone graft substitute volume.
  • ACTIFUSE had a slower resorption rate from Weeks 1 to 6. A significant decrease in BGS volume was seen from 6 to 12 weeks (p<0.0005).

*As demonstrated in an animal model.

References:

  1. Hing KA, Revell PA, Smith N, Buckland T. Effect of silicon level on rate, quality and progression of bone healing within silicate-substituted porous hydroxyapatite scaffolds. Biomaterials. 2006;27(29):5014-5026.
  2. Guth, K, Campion C, Buckland T, Hing KA. Effect of silicate-substitution on attachment and early development of human osteoblast-like cells seeded on microporous hydroxyapatite discs. Adv Eng Mater. 2010;12(4):B77-B82.
  3. Hing KA, Wilson LF, Buckland T. Comparative performance of three ceramic bone graft substitutes. Spine J. 2007; 7(4):475-490.
  4. Wheeler DL, Jenis LG, Kovach ME, Marini J, Turner AS. Efficacy of silicated calcium phosphate graft in posterolateral lumbar fusion in sheep. Spine J. 2007; 7(3):308-317.
  5. Jenis LG, Banco RJ. Efficacy of silicate-substituted calcium phosphate ceramic in posterolateral instrumented lumbar fusion. Spine (Phila Pa 1976). 2010;35(20):E1058-E1063.
  6. Miyazaki M, Tsumura H, Wang JC, Alanay A. An update on bone substitutes for spinal fusion. Eur Spine J. 2009L;18:783–799.
  7. Younger EM, Chapman MW. Morbidity at bone graft donor sites. J OrthopTrauma. 1989;3(3):192-5.
  8. Scaffold Content and Resistance to Irrigation of Several Bone Graft Substitute Materials, Campion. Data on file, Baxter Healthcare Corporation.