NCT01305356

Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: BioMimetic Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

STUDY OBJECTIVES: To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions) STUDY HYPOTHESIS: Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness STUDY RATIONALE: To evaluate a fully synthetic bone graft material 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 Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft

Detailed description

STUDY DESIGN: Prospective, randomized, controlled, non-inferiority, multi-center trial NUMBER OF STUDY CENTERS: 25 NUMBER OF SUBJECTS: 299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3 separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01) STUDY POPULATION: Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure. TREATMENT GROUPS: Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment® Injectable Bone Graft Subjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft). ROUTE OF ADMINISTRATION: Investigational device is manually implanted inside and around the fusion space to ensure Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space STUDY DURATION: Twenty-four month follow-up post-surgery

Conditions

• Degenerative Joint Disease
• Congenital Deformity
• Arthritis
• Osteoarthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Augment® Injectable Bone Graft	Implantation of up to 9cc of Augment® Injectable Bone Graft
PROCEDURE	Autologous bone graft	Implantation of up to 9cc of autologous bone graft

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-04-01
• Completion: 2014-04-01
• First posted: 2011-02-28
• Last updated: 2018-12-26
• Results posted: 2018-12-05

Locations

25 sites across 2 countries: United States, Canada