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
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Demonstration of bridging bone via CT
Timeframe: Months 60 or greater
Subject function as determined by pain on weight bearing
Timeframe: Months 60 or greater
Subject function as determined by AOFAS - AHS score
Timeframe: Months 60 or greater
Subject function as determined by Foot Function Index
Timeframe: Months 60 or greater