Hospital Administrators

AUGMENT^® Regenerative Solutions is the first and only proven alternative to autograft in ankle and hindfoot arthrodesis. Available in two delivery options, AUGMENT^® Bone Graft is a combination of recombinant human platelet derived growth factor BB (rhPDGF-BB), that contributes to mesenchymal stem cell chemotaxis and mitogenesis and angiogenesis; and Beta tri-calcium phosphate (β-TCP) granules, that provide an osteoconductive scaffold to facilitate new bone formation and delivery of rhPDGF-BB. AUGMENT^® Injectable includes the same rhPDGF-BB and (β-TCP) as found in AUGMENT^® Bone Graft, but it also includes a collagen matrix that allows AUGMENT^® to be flowable.

AUGMENT^® Bone Graft was Approved by the FDA through the rigorous PMA process, reserved for unprecedented, pioneer products. As a result of the largest study conducted in foot and ankle history to date, AUGMENT^® was proven equivalent to autograft in clinical outcomes but without any donor site pain.

Fast Facts

• The only Class III US FDA-approved alternative to autograft bone for fusion procedures of the ankle and hindfoot.¹
• Rigorously studied in over 500 patients, across 4 human clinical trials conducted in the US and Canada including the largest Level 1 clinical trial ever conducted in the foot and ankle.^2,3,4
• Approved and safely used in Canada beginning in 2009 and in Australia and New Zealand beginning in 2011^2,5,6,7,8,9 in foot and ankle fusions or surgeries.
• Clinically proven to offer comparable clinical success to the gold standard of autograft bone in foot and ankle fusion procedures.²
• Spares patients all risk for complications, postoperative morbidity, increased surgical time, longer hospital stays, short- and long-term impact on patient quality of life, and interference with routine activities of daily living associated with autograft bone harvest.^{6,10,11,12,13,14,15,16,17,18,19}
• The rhPDGF-BB biologic component is engineered via recombinant DNA technology, as an exact replica of endogenous human PDGF-BB, thus eliminating risk of disease transmission or immune response possible with allogeneic bone.⁵– rhPDGF-BB triggers the tissue healing and bone repair cascade.
• The β-TCP matrix component allows targeted delivery of the rhPDGF-BB, fills the bone defect, provides an osteoconductive matrix, prevents soft tissue prolapse, and provides the environment necessary for the stability of a newly forming callus at the wound healing site.^20,5,21
  – β-TCP is resorbed and replaced with bone during healing.
• AUGMENT^® offers surgeons and patients a better way to achieve fusion, by eliminating the need for harvesting autograft bone.
• Surgeons are in general agreement regarding clinical and radiographic indications for requiring bone graft in F/A fusion surgery.²²
• Nonunion after foot and ankle fusion procedures is indicative of poorer functional outcomes and quality of life.²³
• Improved fusion results on CT are associated with improved clinical outcomes.^*24
• Using graft material in sufficient quantities provides substantive value in maximizing the likelihood of joint fusion and promoting successful clinical union.²⁵

Drawbacks to Autograft Bone Harvest

• There is a finite amount of bone that can be safely and reasonably harvested.^5,26
• The amount of bone available to be harvested may be insufficient, depending on the size of the bone defect to be treated at the primary surgical site, the physical size of the patient, the number of joints to be fused.⁵
• The presence of comorbidities such as osteoporosis can even further reduce the quantity of bone available for harvest.^5,26
• Risk of nonunion during foot and ankle fusion surgery is of clinical concern to surgeons.^5,26
• Some foot and ankle experts suggest that supplementation of foot and ankle fusion procedures should be considered for all patients.¹²

Autograft Bone Harvest is Not Free

The costs associated with bone graft harvest can be substantial when operating room time, instrument costs, anesthesia costs, physician fees, and management of postoperative complications are taken into account:

• Harvesting bone graft may add additional time to the operating room time for the overall fusion procedure.^5,6,19
• Addressing associated complications from bone graft harvest, may add up to 2 additional days to the hospitalization length of stay.^5,15,19,27
• Harvesting bone graft material can slow recovery time leading to lower levels of patient satisfaction, affect activities of daily living, and delay the return to work.²⁸
• There is clinical value in sparing patients of the morbidity associated with the autograft harvest procedure in foot and ankle fusion surgery. Chronic pain is reported at the graft harvest sites, including proximal tibia, distal tibia, calcaneus, and iliac crest.²⁹

*FDA did not base its approval of AUGMENT^® on radiologic findings from the pivotal study, but instead relied on clinical outcomes.

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