N/A
Completed N=299
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Degenerative Joint Disease · Congenital Deformity · Arthritis · Osteoarthritis
Source: ClinicalTrials.gov NCT01305356 ↗
Enrolled (actual)
299
Serious AEs
18.4%
Results posted
Dec 2018
Primary outcomePrimary: Pain on Weight Bearing — 71.0; 70.7; 29.5; 28.2 units on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain on Weight Bearing |
71.0; 70.7; 29.5; 28.2; 26.8; 24.6 | — |
| SECONDARY Foot Function Index (FFI) |
50.6; 50.0; 41.8; 45.0; 33.3; 34.5 | — |
| SECONDARY AOFAS Hindfoot and Ankle Score |
43.3; 43.6; 61.5; 61.5; 66.9; 66.6 | — |
| SECONDARY Fusion Site Pain |
51.4; 50.4; 20.5; 15.4; 18.9; 17.8 | — |
| SECONDARY SF-12 Physical Component Score |
30.8; 30.8; 36.9; 36.3; 37.9; 39.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01305356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.