augment® injectable bone graft compared to autologous bone graft as a bone regeneration device in hindfoot fusions

Conditions: Degenerative Joint Disease; Congenital Deformity; Arthritis; Osteoarthritis; Rheumatoid Arthritis

Summary: 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

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

Eligibility 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 * 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

Keywords: degenerative joint disease djd joint fusion hindfoot congenital deformity osteoarthritis rheumatoid arthritis post-traumatic arthritis ankylosing spondylitis augment(tm) injectable bone graft autologous bone graft autogenous bone graft beta-tcp bovine collagen rhpdgf(bb)