Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
1 other identifier
observational
150
2 countries
26
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2016
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 17, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 27, 2018
March 1, 2018
2.3 years
August 17, 2016
March 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Demonstration of bridging bone via CT
Months 60 or greater
Subject function as determined by pain on weight bearing
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
Study Arms (2)
Group 1
Standard Rigid Fixation plus autograft
Group 2
Standard rigid fixation plus AUGMENT® Bone Graft
Interventions
Eligibility Criteria
Male and female subjects over the age of 18 years of age, who were randomized and treated as part of the population of the BMTI-2006-01 protocol.
You may qualify if:
- 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).
You may not qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Tucson Orthopedic Institute
Tucson, Arizona, 85712, United States
OrthoNorcal
Capitola, California, 95010, United States
California Pacific Medical Center
San Francisco, California, 94118, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Center for Bone and Joint Surgery
Royal Palm Beach, Florida, 33411, United States
Illinois Bone and Joint Institute, LLC
Glenview, Illinois, 60025, United States
MedStar Health Research Institute/ Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525, United States
Michigan Orthopedic Center
Lansing, Michigan, 48910, United States
Desert Orthopaedics
Las Vegas, Nevada, 89121, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
University of Rochester
Rochester, New York, 14642, United States
OrthoCarolina
Charlotte, North Carolina, 28207, United States
Duke University Medical
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Orthopedic Foot and Ankle Center / OhioHealth Research Institute
Westerville, Ohio, 43082, United States
The Center
Bend, Oregon, 97701, United States
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Campbell Clinic
Germantown, Tennessee, 38138, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
The Orthopaedic Foot & Ankle Center
Falls Church, Virginia, 22042, United States
Office of Orthopaedic Surgeons, Talisman Centre North Building
Calgary, Alberta, T2G 5B6, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z-2A5, Canada
QEll Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
St. Michael's Hospital
Toronto, Ontario, M5C 1R6, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Links
Biospecimen
Serum Samples for antibody testing.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2016
First Posted
August 25, 2016
Study Start
August 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 27, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share