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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 94
- Primary Endpoint
- Pain on weight bearing via Visual Analog Scale (VAS)
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Pain on weight bearing via Visual Analog Scale (VAS)
Time Frame: Visit 1 (Day 0)
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).
Secondary Outcomes
- 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))