Why AUGMENT® Regenerative Solutions?
The Fusion Solution in Hindfoot and Ankle
AUGMENT® Regenerative Solutions is a ground breaking technology in foot and ankle in arthrodesis surgery. The product is the first and only FDA approved alternative to autograft in ankle and hindfoot arthrodesis. Literature reports a range of 10% to as high as 41% of all hindfoot and ankle fusions fail to launch.* Can you predict which of your patients will result in a non-union?
*Haddad SL, Coetzee JC, Estok R, Fahrbach K, Banel D, Nalysnyk L. Intermediate and long-term outcomes of total ankle arthroplasty and ankle arthrodesis. A systematic review of the literature. J Bone Joint Surg Am. 2007 Sep;89(9):1899-905.
A Better Way.
- Level 1 evidence from largest F&A clinical trial ever conducted
- Equivalent improvements in clinical outcomes, compared to the gold standard autograft1
- Bioengineered human PDGF-BB stimulates multiple aspects of healing in response to injury
- rhPDGF-BB is highly purified with consistent biological potency; allograft and autograft are highly variable in quality and potency2,3,4,5
- Class III combination product labeled for ankle and hindfoot arthrodesis
- In commercial use since 2009 (Canada)
- Eliminates risks, morbidities, costs associated with autograft harvest
2. Fiedler, et al. J Cell Biochem (2002).
3. Ozaki, et al. J Stem Cells & Dev (2007).
4. Bouletreau, et al. Plast Reconstr Surg (2002).
5. Hollinger, et al. JBJS (2008).
Both AUGMENT® Bone Graft and AUGMENT® Injectable are made up of two components.
- rhPDGF-BB, a man-made protein called recombinant human platelet-derived growth factor (rhPDGF-BB). It is manufactured from yeast cells and has been approved by the FDA for more than 20 years.
- The other part is a bone-like substance called beta-Tricalcium Phosphate (β-TCP), which has been approved by the FDA for more than 32 years for AUGMENT® Bone Graft and includes a collagen matrix to make AUGMENT® Injectable flowable.
Preparing AUGMENT® Bone GraftDOWNLOAD PDF
AUGMENT® Bone Graft is supplied as a two component kit. Each kit consists of:
- A cup containing β-TCP particulate
- A vial containing solution of 0.3 mg/ml rhPDGF-BB in sodium acetate buffer
NOTE: Preparation of this mixture should be done at least 10 minutes before implantation in the joint space(s) intended for arthrodesis because it requires this time period to saturate. Please plan accordingly.
Using sterile technique, transfer both the cup (containing the β-TCP granules) as well as the vial (containing the rhPDGF-BB solution) to the sterile field.
First open the cup and transfer the β‑TCP granules to a separately available sterile surgical bowl.
Then using a syringe and needle, draw up the liquid contents of the vial in its entirety (the rhPDGF-BB solution). Transfer all of the fluid to the surgical bowl containing the β-TCP granules.
Using a spatula, curette, or similar instrument, gently stir these two components together for approximately 30 seconds to ensure a homogeneous mixture. This mixture should, at that point, have the consistency of wet sand.
The rhPDGF-BB saturated graft mixture should be left undisturbed for 10 minutes before being implanted to ensure optimal saturation of the β-TCP particles. Ensure that the entire volume of both components is combined. The product should be implanted within one (1) hour of mixing the two components.
Immediately prior to implantation, the entire contents should be mixed briefly again to ensure complete saturation of the β-TCP particles.
AUGMENT® Bone Graft should be implanted on already prepared host bone surfaces, being careful not to overstuff the joint space(s). This material should be inserted amongst all peri-articular defects (both pre-existent and surgically created). This will maximize bony apposition but not impede direct host bone to host bone apposition.
Any rhPDGF-BB liquid remaining in the bowl after implantation of a sufficient amount of AUGMENT® Bone Graft may then be drawn up and used to hydrate the already implanted AUGMENT® Bone Graft dispersed throughout the fusion site.
Indications for Use
AUGMENT® Bone Graft and AUGMENT® Injectable are indicated for use as an alternative to autograft in arthrodesis (i.e., surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence indicating the need for supplemental graft material.