Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

STUDY DESIGN:

Prospective, randomized, controlled, non-inferiority, multi-center trial

NUMBER OF STUDY CENTERS:

25

NUMBER OF SUBJECTS:

299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3
separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01)

STUDY POPULATION:

Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure
involving a bone grafting procedure.

TREATMENT GROUPS:

Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation +
Augment® Injectable Bone Graft

Subjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft).

ROUTE OF ADMINISTRATION:

Investigational device is manually implanted inside and around the fusion space to ensure
Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous
bone graft is contained within the joint space

STUDY DURATION:

Twenty-four month follow-up post-surgery

KEY INCLUSION CRITERIA:

- at least 18 years old and considered skeletally mature

- diagnosed with degenerative joint disease (DJD) affecting the hindfoot due to a
congenital or acquired deformity, osteoarthritis, rheumatoid arthritis, post-
traumatic arthritis or ankylosing spondylitis of the ankle, subtalar, calcaneocuboid,
and/or talonavicular joints

- requires one of the following hindfoot fusion proceduress with supplemental bone
graft/substitute: ankle fusion (tibiotalar), subtalar fusion (talocalcaneal),
calcaneocuboid fusion, talonavicular fusion, triple arthrodesis (subtalar,
talonavicular and calcaneocuboid joints) OR double fusions (any combination of any two
of the following: subtalar, talonavicular and calcaneocuboid joints)

- fusion site able to be rigidly stabilized with no more than 3 screws across the fusion
site

- supplemental pins or staples allowed

- supplemental screws external to the fusion site(s) allowed

- signed informed consent document, independent, ambulatory, and can comply with all
post-operative evaluations and visits

KEY EXCLUSION CRITERIA:

- undergone previous fusion surgery at the proposed location, i.e., revision of a failed
fusion

- more than one previous procedure at the involved joints

- retained hardware spanning the joint(s) intended for fusion

- procedure anticipated to require plate fixation (including claw plates), IM nails or
more than 3 screws to achieve rigid fixation based on pre-op planning

- procedure expected to require more than 9cc of graft material based on pre-op planning

- procedure expected to require structural bone graft, allograft, bone graft substitute,
platelet rich plasma (PRP) or bone marrow aspirate

- procedure expected to require a pantalar fusion, i.e., fusion of ankle plus all
hindfoot joints (talonavicular, subtalar, and calcaneocuboid) or an ankle fusion in
combination with any hindfoot fusion

- radiographic evidence of bone cysts, segmental defects or growth plate fracture near
the fusion site that could negatively impact the proposed fusion procedure

- tested positive or been treated for a malignancy in the past or is suspected of having
a malignancy or currently undergoing radio- or chemotherapy treatment for a malignancy
anywhere in the body, whether adjacent to or distant from the proposed surgical site

- pre-existing sensory impairment, e.g., diabetics with baseline sensory impairment,
which limits ability to perform objective functional measurements and may be at risk
for complications

- diabetics not sensitive to the 5.07 monofilament (Semmes-Weinstein) are to be
excluded

- metabolic disorder known to adversely affect the skeleton other than primary
osteoporosis or diabetes, e.g., renal osteodystrophy or hypercalcemia

- use of chronic medications known to affect the skeleton, e.g., glucocorticoid usage >
10mg/day

- pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to
perform objective functional measurements

- physically or mentally compromised, e.g., current treatment for a psychiatric
disorder, senile dementia, Alzheimer's disease, etc., to the extent that the
Investigator judges the subject to be unable or unlikely to remain compliant

- allergic to yeast-derived products or bovine collagen or other bovine-sourced products

- received an investigational therapy within 30 days of proposed surgery or during the
follow-up phase of the study

- is a prisoner, known or suspected transient or a history of drug/alcohol abuse within
the 12 months prior to screening

- pregnant or intending to become pregnant within 12 months of the study procedure

- morbidly obese defined as BMI > 45 kg/m2

- currently has an acute infection at the surgical site