Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
NCT ID: NCT01305356
Last Updated: 2018-12-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
299 participants
INTERVENTIONAL
2011-03-31
2014-04-30
Brief Summary
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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
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Augment® Injectable Bone Graft
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
Augment® Injectable Bone Graft
Implantation of up to 9cc of Augment® Injectable Bone Graft
Autologous bone graft
Standard Rigid Fixation + Autologous bone graft
Autologous bone graft
Implantation of up to 9cc of autologous bone graft
Interventions
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Augment® Injectable Bone Graft
Implantation of up to 9cc of Augment® Injectable Bone Graft
Autologous bone graft
Implantation of up to 9cc of autologous bone graft
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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BioMimetic Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Roach
Role: STUDY_DIRECTOR
Stryker Trauma and Extremities
Christopher DiGiovanni, MD
Role: PRINCIPAL_INVESTIGATOR
University Orthopaedics, Inc.
Locations
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Tucson Orthopaedic Research Center
Tucson, Arizona, United States
University of Arizona
Tucson, Arizona, United States
California Pacific Medical Center
San Francisco, California, United States
Illinois Bone & Joint Institute, Ltd.
Glenview, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Mid Michigan Orthopaedic Institute
East Lansing, Michigan, United States
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States
Desert Orthopaedic Center
Las Vegas, Nevada, United States
University of Medicine & Dentistry of New Jersey
Newark, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
OrthoCarolina, PA
Charlotte, North Carolina, United States
Cleveland Clinic Orthopaedic
Cleveland, Ohio, United States
Orthopedic Foot & Ankle Center
Columbus, Ohio, United States
Health Research Institute, Inc.
Oklahoma City, Oklahoma, United States
The Rothman Institute
Philadelphia, Pennsylvania, United States
Campbell Clinic / InMotion Orthopaedic Research Center
Memphis, Tennessee, United States
Texas Health Research & Education Institute
Dallas, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
Life Mark Health Centre
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Services
Halifax, Nova Scotia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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Daniels TR, Younger AS, Penner MJ, Wing KJ, Le IL, Russell IS, Lalonde KA, Evangelista PT, Quiton JD, Glazebrook M, DiGiovanni CW. Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a beta-TCP-Collagen Matrix. Foot Ankle Int. 2015 Jul;36(7):739-48. doi: 10.1177/1071100715576370. Epub 2015 Apr 6.
DiGiovanni CW, Lin SS, Baumhauer JF, Daniels T, Younger A, Glazebrook M, Anderson J, Anderson R, Evangelista P, Lynch SE; North American Orthopedic Foot and Ankle Study Group. Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/beta-TCP): an alternative to autogenous bone graft. J Bone Joint Surg Am. 2013 Jul 3;95(13):1184-92. doi: 10.2106/JBJS.K.01422.
Other Identifiers
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BMTI-2010-01
Identifier Type: -
Identifier Source: org_study_id
NCT01008891
Identifier Type: -
Identifier Source: nct_alias