Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Public ClinicalTrials.gov record NCT01305356. 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® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01305356
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 299 participants
Conditions and interventions
Conditions
Interventions
- Augment® Injectable Bone Graft Device
- Autologous bone graft Procedure
Device · Procedure
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
- Mar 2011 (Actual)
- Primary completion
- Apr 2013 (Actual)
- Completion
- Apr 2014 (Actual)
- Last update posted
- Dec 26, 2018
2011 – 2014
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tucson Orthopaedic Research Center | Tucson | Arizona | 85712 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| California Pacific Medical Center | San Francisco | California | 94118 | — |
| Illinois Bone & Joint Institute, Ltd. | Glenview | Illinois | 60025 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Mid Michigan Orthopaedic Institute | East Lansing | Michigan | 48823 | — |
| Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan | 49525 | — |
| Desert Orthopaedic Center | Las Vegas | Nevada | 89121 | — |
| University of Medicine & Dentistry of New Jersey | Newark | New Jersey | 07101 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| OrthoCarolina, PA | Charlotte | North Carolina | 28207 | — |
| Cleveland Clinic Orthopaedic | Cleveland | Ohio | 44195 | — |
| Orthopedic Foot & Ankle Center | Columbus | Ohio | 43231 | — |
| Health Research Institute, Inc. | Oklahoma City | Oklahoma | 73109 | — |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | — |
| Campbell Clinic / InMotion Orthopaedic Research Center | Memphis | Tennessee | 38138 | — |
| Texas Health Research & Education Institute | Dallas | Texas | 75231 | — |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | — |
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 NCT01305356, 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 Dec 26, 2018 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01305356 live on ClinicalTrials.gov.