Long-term Safety and Effectiveness of AUGMENT® Injectable 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® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
1 other identifier
observational
94
0 countries
N/A
Brief Summary
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft 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-2009-01 or BMTI-2010-01. STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Injectable 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 2019
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
First Submitted
Initial submission to the registry
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJuly 9, 2019
July 1, 2019
1.8 years
June 19, 2019
July 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain on weight bearing via Visual Analog Scale (VAS)
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Visit 1 (Day 0)
Secondary Outcomes (3)
Confirmation of bridging bone via computerized tomography (CT)
Visit 1 (Day 0)
AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score
Visit 1 (Day 0)
Foot Function Index, FFI
Visit 1 (Day 0)
Study Arms (2)
Autograft
Standard Rigid Fixation plus autograft
AUGMENT® Injectable
Standard rigid fixation plus AUGMENT® Injectable 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-2009-01 or BMTI-2010-01 protocol.
You may qualify if:
- 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 included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED).
You may not qualify if:
- \) Subjects that were excluded from the safety analysis in the BMTI-2009-01 or BMTI-2010-01 study. These subjects were consented, but never treated as part of the BMTI-2009-01 or BMTI-2010-01 protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
June 19, 2019
First Posted
June 26, 2019
Study Start
August 1, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
July 9, 2019
Record last verified: 2019-07