Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft

Status unconfirmed

Conditions studied: Ankle and Hindfoot Arthrodesis

In brief

The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated 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-2006-01. STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up. REGULATORY PHASE: Post-approval study

Key facts

Study ID

NCT02879149

Run by

BioMimetic Therapeutics

People needed

150

Starts

2016-08-01

Expected to finish

2018-12-01

Last updated by the study team

2018-03-27

Who can join

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

You may qualify if…

• Subjects who meet the following criteria may be included in the study:
• Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
• Must have been randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).

You may not qualify if…

• Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 protocol.

Where it is running

• Tucson Orthopedic Institute — Tucson, Arizona, United States (enrolling)
• OrthoNorcal — Capitola, California, United States (enrolling)
• California Pacific Medical Center — San Francisco, California, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Center for Bone and Joint Surgery — Royal Palm Beach, Florida, United States (enrolling)
• Illinois Bone and Joint Institute, LLC — Glenview, Illinois, United States (enrolling)
• MedStar Health Research Institute/ Union Memorial Hospital — Baltimore, Maryland, United States (enrolling)
• Orthopaedic Associates of Michigan, PC — Grand Rapids, Michigan, United States (enrolling)
• Michigan Orthopedic Center — Lansing, Michigan, United States (enrolling)
• Desert Orthopaedics — Las Vegas, Nevada, United States (enrolling)
• Rutgers New Jersey Medical School — Newark, New Jersey, United States (enrolling)
• University of Rochester — Rochester, New York, United States (enrolling)
• OrthoCarolina — Charlotte, North Carolina, United States (enrolling)
• Duke University Medical — Durham, North Carolina, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Orthopedic Foot and Ankle Center / OhioHealth Research Institute — Westerville, Ohio, United States (enrolling)
• The Center — Bend, Oregon, United States (enrolling)
• Rothman Institute — Philadelphia, Pennsylvania, United States (enrolling)
• Campbell Clinic — Germantown, Tennessee, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• The Orthopaedic Foot & Ankle Center — Falls Church, Virginia, United States (enrolling)
• Office of Orthopaedic Surgeons, Talisman Centre North Building — Calgary, Alberta, Canada (enrolling)
• St. Paul's Hospital — Vancouver, British Columbia, Canada (enrolling)
• QEll Health Sciences Centre — Halifax, Nova Scotia, Canada (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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