NCT03998137

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 94 (estimated)
• Sponsor: BioMimetic Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ankle and Hindfoot Arthrodesis

Interventions

Type	Name	Description
DEVICE	AUGMENT® Injectable Bone Graft	AUGMENT® Injectable Bone Graft
PROCEDURE	Standard of Care	Autologous Bone Graft

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-06-26
• Last updated: 2019-07-09

Regulatory

• FDA-regulated device study