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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 is a NA study that has completed, run by BioMimetic Therapeutics. The registered enrollment target is 414 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00583375
The ClinicalTrials.gov registry entry for NCT00583375 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 414 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMimetic Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT00583375 reports 0 study locations.
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.
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