Last updated on March 2018

Long-term Safety and Effectiveness of AUGMENT Bone Graft Compared to Autologous Bone Graft


Brief description of study

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

Clinical Study Identifier: NCT02879149

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