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NCT01305356 · ClinicalTrials.gov registry record · NA
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
A NA study, sponsored by BioMimetic Therapeutics.
- Completed
- Registry status
- NA
- Development phase
- 299
- Enrollment target
NCT01305356 is a NA study that has completed, run by BioMimetic Therapeutics. The registered enrollment target is 299 participants.
The verdict
NCT01305356, a NA study, has completed, sponsored by BioMimetic Therapeutics.
- COMPLETED
- Registry status
- NA
- Development phase
- 299 participants
- Enrollment target
Study Summary
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
Interventions
- DEVICE Augment® Injectable Bone Graft
- PROCEDURE Autologous bone graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01305356
The ClinicalTrials.gov registry entry for NCT01305356 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 299 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 Augment® Injectable Bone Graft is the first listed.
NCT01305356 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01305356 about?
NCT01305356 is a clinical study titled "Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions". 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...
What is the current status of trial NCT01305356?
This trial is currently completed. It is a NA study. The enrollment target is 299 participants. The study started on 2011-03. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01305356?
The interventions under investigation include: Augment® Injectable Bone Graft (DEVICE), Autologous bone graft (PROCEDURE).
Who is sponsoring clinical trial NCT01305356?
This trial is sponsored by BioMimetic Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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