Ankle and Hindfoot Arthrodesis Clinical Trial
Official title:
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
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02879149 -
Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
|