How ACTIFUSE Bone Graft Substitute Works

How ACTIFUSE Bone Graft Substitute Works

The patented silicate substitution process facilitates natural bone remodeling.

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What the Data Says

What the Data Says

Review the key studies on ACTIFUSE Bone Graft Substitute in more detail.

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The ACTIFUSE Bone Graft Substitute Advantage

The ACTIFUSE Advantage

Comparison to Iliac Crest

ACTIFUSE Bone Graft Substitute 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).
Distinctive and Versatile

Distinctive and Versatile

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.*6

Optimal Silicon Level*1

0.8 wt% silicon shown to be optimal for accelerated bone formation.

Optimal Silicon Level
  • BGS samples were implanted into the lower femur of rabbits with surgically created osseous defects (4.8 ± 0.3 mm diameter, 6–7 mm length).
  • The sample size was n=4 per implant retrieval time point.
  • Histomorphometry, using point counting, was used to determine the normalized bone volume percentage.
  • For the 0.8 wt% silicon group, there was a statistically significant increase in bone volume from Week 3 to 12 (p<0.05) and from Week 6 to 12 (p<0.005).

Increased Cell Attachment*2

Significantly more cells attach to ACTIFUSE Bone Graft Substitute than calcium phosphate.

Increased Cell Attachment
  • Cell attachment was measured on discs incubated with osteoblast-like cells.
  • For discs cultured in SFM (serum-free medium) with a 1 hour precondition in C-MEM (complete medium), cell attachment on ACTIFUSE Bone Graft Substitute was statistically significant compared to calcium phosphate at all time points until 90 minutes of incubation (p<0.001).

Accelerated Bone Formation*3

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

Accelerated Bone Formation
  • BGS samples were implanted into the 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 inter-treatment comparison of mean levels of percent normalized bone volume at specific time points showed consistently greater levels within ACTIFUSE Bone Graft Substitute-treated defects, reaching significance at 3 weeks (p<0.0001), 6 weeks (p<0.0001) and 12 weeks (p<0.05).

Natural Remodeling and Graft Resorption*3

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

Natural Remodeling and Graph Resorption
  • BGS 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 Bone Graft Substitute 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).

*Preclinical data. Results may not correlate to performance in humans.

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. Scaffold Content and Resistance to Irrigation of Several Bone Graft Substitute Materials, Campion. Data on file, Baxter Healthcare Corporation.