Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
NCT ID: NCT00583375
Last Updated: 2018-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
414 participants
INTERVENTIONAL
2007-04-30
2010-02-28
Brief Summary
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STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis
STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute 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 ABG without necessitating an additional invasive procedure to harvest the graft
REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA) Application as a bone regeneration system, pivotal phase
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
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
* Ankle joint fusion
* Subtalar fusion
* Calcaneocuboid fusion
* Talonavicular fusion
* Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
* Double fusions (talonavicular and calcaneocuboid joints)
Exclusion Criteria
2. The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage \> 10mg/day).
3. Pregnant or a female intending to become pregnant during this study period.
4. Morbidly obese (BMI \> 45 kg/m2)
18 Years
ALL
No
Sponsors
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BioMimetic Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher DiGiovanni, M.D.
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Locations
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Tucson Orthopaedic Institute
Tucson, Arizona, United States
California Pacific Orthopaedics & Sports Medicine
San Francisco, California, United States
Santa Cruz Orthopaedic Institute
Santa Cruz, California, United States
Hartford Hospital Orthopaedic Center
Hartford, Connecticut, United States
The Center for Bone & Joint Surgery
Royal Palm Beach, Florida, United States
Southern Orthopaedic Center
Savannah, Georgia, United States
Illinois Bone and Joint Institute, Ltd.
Glenview, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
SIU School of Medicine
Springfield, Illinois, United States
Advanced Orthopaedic Associates
Wichita, Kansas, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Mid Michigan Orthopaedic Institute
East Lansing, Michigan, United States
Orthopaedic Associates of Grand Rapids
Grand Rapids, Michigan, United States
Henry Ford Hospital - West Bloomfield
West Bloomfield, Michigan, United States
Desert Orthopaedic Center
Las Vegas, Nevada, United States
UMDNJ
Newark, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Ortho Carolina Research Institute
Charlotte, North Carolina, United States
Duke Health Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Orthopedic Foot & Ankle Center
Columbus, Ohio, United States
Orthopaedic & Neurosurgical Care & Research
Bend, Oregon, United States
The Rothman Institute
Philadelphia, Pennsylvania, United States
University Orthopaedics, Inc
Providence, Rhode Island, United States
Campbell Clinic
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Bone and Joint Clinic of Houston
Houston, Texas, United States
The Orthopaedic Foot and Ankle Center
Arlington, Virginia, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Peter Lougheed Centre
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Other Identifiers
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BMTI-2006-01
Identifier Type: -
Identifier Source: org_study_id
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