NCT00583375

Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions

A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: BioMimetic Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA) Application as a bone regeneration system, pivotal phase

Conditions

• Foot Fusion

Interventions

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

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-01-01
• Completion: 2010-02-01
• First posted: 2007-12-31
• Last updated: 2018-04-02
• Results posted: 2018-02-23

Locations

37 sites across 2 countries: United States, Canada