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NCT00583375 · ClinicalTrials.gov registry record · NA
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
A NA study, sponsored by BioMimetic Therapeutics.
- Completed
- Registry status
- NA
- Development phase
- 414
- Enrollment target
NCT00583375: Completed NA study, sponsored by BioMimetic Therapeutics.
NCT00583375 is a NA study that has completed, run by BioMimetic Therapeutics. The registered enrollment target is 414 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00583375, a NA study, has completed, sponsored by BioMimetic Therapeutics.
- COMPLETED
- Registry status
- NA
- Development phase
- 414 participants
- Enrollment target
Study Summary
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
Primary Outcome
An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused.
Interventions
- PROCEDURE Standard of Care
- DEVICE Augment® Bone Graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-02 |
| Phase | NA |
What the finished NCT00583375 record still lists
NCT00583375 is an interventional study that assigns participants to a tested intervention. The registered 414 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT00583375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00583375 about?
NCT00583375 is a clinical study titled "Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions". 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...
What is the current status of trial NCT00583375?
This trial is currently completed. It is a NA study. The enrollment target is 414 participants. The study started on 2007-04. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00583375?
The interventions under investigation include: Standard of Care (PROCEDURE), Augment® Bone Graft (DEVICE).
Who is sponsoring clinical trial NCT00583375?
This trial is sponsored by BioMimetic Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00583375's enrollment target sits among peer trials
414 241st of 2000 higher than 1,760 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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