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

Completed · Not applicable

Conditions studied: Foot Fusion

In brief

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

Key facts

Study ID

NCT00583375

Run by

BioMimetic Therapeutics

People needed

414

Starts

2007-04-01

Expected to finish

2010-02-01

Last updated by the study team

2018-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bone defect in the hindfoot or ankle requiring fusion using open surgical technique with supplemental bone graft/substitute, requiring one of the following procedures:
• Ankle joint fusion
• Subtalar fusion
• Calcaneocuboid fusion
• Talonavicular fusion
• Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
• Double fusions (talonavicular and calcaneocuboid joints)

You may not qualify if…

• Previous fusion surgery of the proposed fusion site.
• The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day).
• Pregnant or a female intending to become pregnant during this study period.
• Morbidly obese (BMI > 45 kg/m2)

Where it is running

• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• California Pacific Orthopaedics & Sports Medicine — San Francisco, California, United States
• Santa Cruz Orthopaedic Institute — Santa Cruz, California, United States
• Hartford Hospital Orthopaedic Center — Hartford, Connecticut, United States
• The Center for Bone & Joint Surgery — Royal Palm Beach, Florida, United States
• Southern Orthopaedic Center — Savannah, Georgia, United States
• Illinois Bone and Joint Institute, Ltd. — Glenview, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• SIU School of Medicine — Springfield, Illinois, United States
• Advanced Orthopaedic Associates — Wichita, Kansas, United States
• Union Memorial Hospital — Baltimore, Maryland, United States
• Mid Michigan Orthopaedic Institute — East Lansing, Michigan, United States
• Orthopaedic Associates of Grand Rapids — Grand Rapids, Michigan, United States
• Henry Ford Hospital - West Bloomfield — West Bloomfield, Michigan, United States
• Desert Orthopaedic Center — Las Vegas, Nevada, United States
• UMDNJ — Newark, New Jersey, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Ortho Carolina Research Institute — Charlotte, North Carolina, United States
• Duke Health Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Orthopedic Foot & Ankle Center — Columbus, Ohio, United States
• Orthopaedic & Neurosurgical Care & Research — Bend, Oregon, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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