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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ACTIFUSE Bone Graft Substitute Advantage

ACTIFUSE Bone Graft Substitute Advantage

Understand what distinguishes it from traditional bone graft substitutes.

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Contact a Baxter rep in your area.

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Studies

Efficacy of silicate-substituted calcium phosphate ceramic in posterolateral instrumented lumbar fusion.

Authors: Jenis LG, Banco RJ.
Journal Citation: Spine (Phila Pa 1976). 2010;35(20):E1058-E1063.

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Design:

  • Retrospective, non-randomized, consecutive series performed by 2 surgeons with 2-year clinical and radiographic follow-up
  • 42 patients (39 patients total, 3 lost to follow-up) with 1- or 2-level lumbar degenerative disorders underwent an instrumented Posterolateral Lumbar Fusion (PLF)
  • Surgical levels included 15 patients who underwent 2-level and 27 patients with single-level fusion procedures
  • The fusion mixture was using 10 mL of ACTIFUSE with 10 mL of Bone Marrow Aspirate (BMA)

Methods:

  • CT scans with axial cuts were used to evaluate the fusion by an independent radiologist

Results:

  • Results were at 6 months 35% of levels revealed fusion, which increased to 76.2% and 76.5% at 12 and 24 months respectively

Conclusions:

  • Fusion rates for ACTIFUSE-treated patients are comparable to historical autograft controls
  • No instances of ectopic bone formation or osteolysis associated with the use of ACTIFUSE in this series

PLF – Posterolateral Lumbar Fusion
BMA – Bone Marrow Aspirate

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Efficacy of silicated calcium phosphate graft in posterolateral lumbar fusion in sheep.

Authors: Wheeler DL, Jenis LG, Kovach ME, Marini J, Turner AS.
Journal Citation: Spine J. 2007;7(3):308-317.

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Design:

  • Ovine model
  • Instrumented Posterior Lateral Fusion (L4-L5)
  • Groups: Iliac crest bone graft (ICBG), ACTIFUSE (n=9/group)
  • Time points: 2 and 6 months

Methods:

  • Quantitative CT
  • Radiographic evaluation
  • Biomechanical evaluation
  • Histological evaluation

Results:

  • Si-CaP and ICBG produced biomechanical and radiographical equivalent fusion masses
  • Bony bridging was equivalent between Si-CaP and ICBG

Conclusions:

  • Si-CaP was equivalent to ICBG in generating a solid, bony, intertransverse process fusion in an ovine model
  • Both treatment groups achieved 100% bridging fusion after 6 months of healing

Si-CaP – Silicated Calcium Phosphate
ICBG – Illiac Crest Bone Graft

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Comparative performance of three ceramic bone graft substitutes.

Authors: Hing KA, Wilson LF, Buckland T.
Journal Citation: Spine J. 2007; 7(4):475-490.

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Design:

  • Lapine (rabbit) femoral condyle, 4.8 mm in diameter drill defect
  • Groups: D-CaS, ß-TCP, Si-Cap (n=4/BGS per time point)
  • Time points: 1, 3, 6, 12 weeks

Methods:

  • Histological evaluation
  • Histomorphometric quantification (% new bone, % BGS, capillary index, MAR)

Results:

  • Normalized bone volume higher for Si-Cap than D-CaS and ß-TCP at 3, 6, and 12 weeks
  • Si-Cap demonstrated elevated MAR between Weeks 1-2 compared to all other groups
  • ß-TCP degradation products provoked an inflammatory response and the Si-Cap scaffolds appeared more stable and supported further bone apposition as a result of cell mediated remodeling

Conclusions:

  • Si-Cap appeared to provide a more stable osteoconductive scaffold, which supported faster angiogenesis and bone apposition throughout the defect site, with the development of a functionally adaptive trabecular structure through resorption/remodeling of both scaffold and new bone

D-CaS – Dense Calcium Sulfate
ß-TCP – Beta Tri-Calcium Phosphate
Si-Cap – Silicated Calcium Phosphate
BGS – Bone Graft Substitute
MAR – Mineral Apposition Rate

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Effect of silicon level on rate, quality and progression of bone healing within silicate-substituted porous hydroxyapatite scaffolds.

Authors: Hing KA, Revell PA, Smith N. Buckland T.
Journal Citation: Biomaterials. 2006;27:5014-5026.

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Design:

  • Rabbit femoral condyle, 4.5 to 5.1 mm drill defect
  • Groups: 0, 0.2, 0.4, 0.8, and 1.5 wt% Si (n=4/group)
  • Time points: 1, 3, 6, 12 weeks

Methods:

  • Histological evaluation
  • Histomorphometric quantification of bone ingrowth
  • Mineral apposition rate (MAR)

Results:

  • 0.8 wt% Si resulted in significantly more bone ingrowth than all other groups at 3 and 6 weeks
  • 0.8 wt% demonstrated elevated MAR between Weeks 1-2 compared to all other Si-containing groups

Conclusions:

  • Highlights sensitivity of healing response to Si levels
  • Optimal response is obtained when hydroxyapatite is substituted with 0.8 wt% Si

Si-Cap – Silicated Calcium Phosphate
Si – Silicate
MAR – Mineral Apposition Rate

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