NCT01305356
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
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COMPLETED
NCT01305356
INTERVENTIONAL
A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
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
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
Degenerative Joint Disease
Congenital Deformity
Arthritis
Osteoarthritis
Rheumatoid Arthritis
- TREATMENT
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- Type: DEVICE
- Name: Augment® Injectable Bone Graft
- Description: Implantation of up to 9cc of Augment® Injectable Bone Graft
- Arm Group Labels: Augment® Injectable Bone Graft
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- Type: PROCEDURE
- Name: Autologous bone graft
- Description: Implantation of up to 9cc of autologous bone graft
- Arm Group Labels: Autologous bone graft
- BioMimetic Therapeutics