Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
- Conditions
- Ankle and Hindfoot Arthrodesis
- Interventions
- Procedure: Standard of CareDevice: AUGMENT® Bone Graft
- Registration Number
- NCT02879149
- Lead Sponsor
- BioMimetic Therapeutics
- Brief Summary
The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under Protocol BMTI-2006-01.
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Subjects who meet the following criteria may be included in the study:
- Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
- Must have been randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).
- Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Standard of Care Standard Rigid Fixation plus autograft Group 2 AUGMENT® Bone Graft Standard rigid fixation plus AUGMENT® Bone Graft
- Primary Outcome Measures
Name Time Method Subject function as determined by pain on weight bearing Months 60 or greater Demonstration of bridging bone via CT Months 60 or greater Subject function as determined by AOFAS - AHS score Months 60 or greater Subject function as determined by Foot Function Index Months 60 or greater
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Illinois Bone and Joint Institute, LLC
🇺🇸Glenview, Illinois, United States
MedStar Health Research Institute/ Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Tucson Orthopedic Institute
🇺🇸Tucson, Arizona, United States
OrthoNorcal
🇺🇸Capitola, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Center for Bone and Joint Surgery
🇺🇸Royal Palm Beach, Florida, United States
Orthopaedic Associates of Michigan, PC
🇺🇸Grand Rapids, Michigan, United States
Michigan Orthopedic Center
🇺🇸Lansing, Michigan, 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
Orthopedic Foot and Ankle Center / OhioHealth Research Institute
🇺🇸Westerville, Ohio, United States
The Center
🇺🇸Bend, Oregon, United States
Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States
The Orthopaedic Foot & Ankle Center
🇺🇸Falls Church, Virginia, United States
Campbell Clinic
🇺🇸Germantown, Tennessee, United States
Office of Orthopaedic Surgeons, Talisman Centre North Building
🇨🇦Calgary, Alberta, Canada
QEll Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Desert Orthopaedics
🇺🇸Las Vegas, Nevada, United States
Duke University Medical
🇺🇸Durham, North Carolina, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada