Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
Public ClinicalTrials.gov record NCT00583375. 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, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the 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.
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
Study identification
- NCT ID
- NCT00583375
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 414 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
- Apr 2007 (Type not available)
- Primary completion
- Jan 2010 (Actual)
- Completion
- Feb 2010 (Actual)
- Last update posted
- Apr 2, 2018
2007 – 2010
United States locations
- U.S. sites
- 31
- U.S. states
- 21
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | — |
| California Pacific Orthopaedics & Sports Medicine | San Francisco | California | 94118 | — |
| Santa Cruz Orthopaedic Institute | Santa Cruz | California | 95065 | — |
| Hartford Hospital Orthopaedic Center | Hartford | Connecticut | 06106 | — |
| The Center for Bone & Joint Surgery | Royal Palm Beach | Florida | 33411 | — |
| Southern Orthopaedic Center | Savannah | Georgia | 31405 | — |
| Illinois Bone and Joint Institute, Ltd. | Glenview | Illinois | 60025 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| SIU School of Medicine | Springfield | Illinois | 62794 | — |
| Advanced Orthopaedic Associates | Wichita | Kansas | 67226 | — |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Mid Michigan Orthopaedic Institute | East Lansing | Michigan | 48823 | — |
| Orthopaedic Associates of Grand Rapids | Grand Rapids | Michigan | 49525 | — |
| Henry Ford Hospital - West Bloomfield | West Bloomfield | Michigan | 48322 | — |
| Desert Orthopaedic Center | Las Vegas | Nevada | 89121 | — |
| UMDNJ | Newark | New Jersey | 07103 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of Rochester Medical Center | Rochester | New York | 14627 | — |
| Ortho Carolina Research Institute | Charlotte | North Carolina | 28209 | — |
| Duke Health Center | Durham | North Carolina | 27704 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Orthopedic Foot & Ankle Center | Columbus | Ohio | 43231 | — |
| Orthopaedic & Neurosurgical Care & Research | Bend | Oregon | 97701 | — |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | — |
| University Orthopaedics, Inc | Providence | Rhode Island | 02905 | — |
| Campbell Clinic | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Bone and Joint Clinic of Houston | Houston | Texas | 77030 | — |
| The Orthopaedic Foot and Ankle Center | Arlington | Virginia | 22206 | — |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00583375, 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 Apr 2, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00583375 live on ClinicalTrials.gov.