Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
NCT ID: NCT02879149
Last Updated: 2018-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2016-08-31
2018-12-31
Brief Summary
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Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2006-01.
STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.
REGULATORY PHASE: Post-approval study
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Standard Rigid Fixation plus autograft
Standard of Care
Autologous Bone Graft
Group 2
Standard rigid fixation plus AUGMENT® Bone Graft
AUGMENT® Bone Graft
AUGMENT® Bone Graft
Interventions
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AUGMENT® Bone Graft
AUGMENT® Bone Graft
Standard of Care
Autologous Bone Graft
Eligibility Criteria
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Inclusion Criteria
1. Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
2. Must have been randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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BioMimetic Therapeutics
INDUSTRY
Responsible Party
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Locations
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Tucson Orthopedic Institute
Tucson, Arizona, United States
OrthoNorcal
Capitola, California, United States
California Pacific Medical Center
San Francisco, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Center for Bone and Joint Surgery
Royal Palm Beach, Florida, United States
Illinois Bone and Joint Institute, LLC
Glenview, Illinois, United States
MedStar Health Research Institute/ Union Memorial Hospital
Baltimore, Maryland, United States
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States
Michigan Orthopedic Center
Lansing, Michigan, United States
Desert Orthopaedics
Las Vegas, Nevada, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
University of Rochester
Rochester, New York, United States
OrthoCarolina
Charlotte, North Carolina, United States
Duke University Medical
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Orthopedic Foot and Ankle Center / OhioHealth Research Institute
Westerville, Ohio, United States
The Center
Bend, Oregon, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
Campbell Clinic
Germantown, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
The Orthopaedic Foot & Ankle Center
Falls Church, Virginia, United States
Office of Orthopaedic Surgeons, Talisman Centre North Building
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
QEll Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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BMTI-2015-01
Identifier Type: -
Identifier Source: org_study_id
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