Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Completed · Not applicable
Conditions studied: Degenerative Joint Disease, Congenital Deformity, Arthritis, Osteoarthritis, Rheumatoid Arthritis
In brief
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
Key facts
- Study ID
- NCT01305356
- Run by
- BioMimetic Therapeutics
- People needed
- 299
- Starts
- 2011-03-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2018-12-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Tucson Orthopaedic Research Center — Tucson, Arizona, United States
- University of Arizona — Tucson, Arizona, United States
- California Pacific Medical Center — San Francisco, California, United States
- Illinois Bone & Joint Institute, Ltd. — Glenview, Illinois, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Union Memorial Hospital — Baltimore, Maryland, United States
- Mid Michigan Orthopaedic Institute — East Lansing, Michigan, United States
- Orthopaedic Associates of Michigan, PC — Grand Rapids, Michigan, United States
- Desert Orthopaedic Center — Las Vegas, Nevada, United States
- University of Medicine & Dentistry of New Jersey — Newark, New Jersey, United States
- Hospital for Special Surgery — New York, New York, United States
- University of Rochester Medical Center — Rochester, New York, United States
- OrthoCarolina, PA — Charlotte, North Carolina, United States
- Cleveland Clinic Orthopaedic — Cleveland, Ohio, United States
- Orthopedic Foot & Ankle Center — Columbus, Ohio, United States
- Health Research Institute, Inc. — Oklahoma City, Oklahoma, United States
- The Rothman Institute — Philadelphia, Pennsylvania, United States
- Campbell Clinic / InMotion Orthopaedic Research Center — Memphis, Tennessee, United States
- Texas Health Research & Education Institute — Dallas, Texas, United States
- St. Luke's Episcopal Hospital — Houston, Texas, United States
- Life Mark Health Centre — Calgary, Alberta, Canada
- St. Paul's Hospital — Vancouver, British Columbia, Canada
- Queen Elizabeth II Health Services — Halifax, Nova Scotia, Canada
- The Ottawa Hospital — Ottawa, Ontario, Canada
- St. Michael's Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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