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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: Completed NA study, sponsored by BioMimetic Therapeutics.
NCT01305356 is a NA study that has completed, run by BioMimetic Therapeutics. The registered enrollment target is 299 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
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 |
What the finished NCT01305356 record still lists
NCT01305356 is an interventional study that assigns participants to a tested intervention. The registered 299 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 (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Augment® Injectable Bone Graft is the first listed.
NCT01305356 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01305356's enrollment target sits among peer trials
299 371st of 2000 higher than 1,630 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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