Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
Public ClinicalTrials.gov record NCT02879149. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT02879149
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2016
- Primary completion
- Nov 30, 2018
- Completion
- Nov 30, 2018
- Last update posted
- Mar 26, 2018
2016 – 2018
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tucson Orthopedic Institute | Tucson | Arizona | 85712 | Recruiting |
| OrthoNorcal | Capitola | California | 95010 | Recruiting |
| California Pacific Medical Center | San Francisco | California | 94118 | Recruiting |
| Hartford Hospital | Hartford | Connecticut | 06102 | Recruiting |
| Center for Bone and Joint Surgery | Royal Palm Beach | Florida | 33411 | Recruiting |
| Illinois Bone and Joint Institute, LLC | Glenview | Illinois | 60025 | Recruiting |
| MedStar Health Research Institute/ Union Memorial Hospital | Baltimore | Maryland | 21218 | Recruiting |
| Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan | 49525 | Recruiting |
| Michigan Orthopedic Center | Lansing | Michigan | 48910 | Recruiting |
| Desert Orthopaedics | Las Vegas | Nevada | 89121 | Recruiting |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | Recruiting |
| University of Rochester | Rochester | New York | 14642 | Recruiting |
| OrthoCarolina | Charlotte | North Carolina | 28207 | Recruiting |
| Duke University Medical | Durham | North Carolina | — | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Orthopedic Foot and Ankle Center / OhioHealth Research Institute | Westerville | Ohio | 43082 | Recruiting |
| The Center | Bend | Oregon | 97701 | Recruiting |
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Campbell Clinic | Germantown | Tennessee | 38138 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| The Orthopaedic Foot & Ankle Center | Falls Church | Virginia | 22042 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02879149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2018 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02879149 live on ClinicalTrials.gov.