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STUDY OBJECTIVES:
To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)
STUDY HYPOTHESIS:
Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness
STUDY RATIONALE:
To evaluate a fully synthetic bone graft material to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft
Full description
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
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Inclusion and exclusion criteria
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
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
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
Primary purpose
Allocation
Interventional model
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299 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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