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NCT00853489 · ClinicalTrials.gov registry record · Phase 4
rhBMP-2 Versus Autograft in Critical Size Tibial Defects
A Phase 4 study, sponsored by St. Louis University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT00853489: Clinical Trial Phase 4 study, sponsored by St. Louis University.
NCT00853489 is a Phase 4 study that was terminated before completion, run by St. Louis University. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853489, a Phase 4 study, was terminated before completion, sponsored by St. Louis University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of our study is to evaluate the use of recombinant human bone morphogenetic protein 2 (RhBMP-2) as compared to standard ICBG in the treatment of severe open tibia fractures with a critical size bone defect (at least one centimeter in length compromising at least 50% of the circumference of the bone).
Primary Outcome
Union will be defined by: 1\. Radiographic union as defined by the Radiographic union scale in tibia fractures (RUST) score, Radiographic evaluation will be assessed by blinded orthopaedic surgeons.
Interventions
- DEVICE recombinant bone morphogenetic protein 2
- PROCEDURE Autogenous iliac crest bone graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-08 |
| Est. Completion | 2017-02-17 |
| Phase | Phase 4 |
Why NCT00853489 stopped before completion
NCT00853489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which recombinant bone morphogenetic protein 2 is the first listed.
NCT00853489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853489 about?
NCT00853489 is a clinical study titled "rhBMP-2 Versus Autograft in Critical Size Tibial Defects". The purpose of our study is to evaluate the use of recombinant human bone morphogenetic protein 2 (RhBMP-2) as compared to standard ICBG in the treatment of severe open tibia fractures with a critical size bone defect (at least one centimeter in length compromising at least 50% of the circumference ...
What is the current status of trial NCT00853489?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2011-08. Estimated completion is 2017-02-17.
What interventions are being tested in trial NCT00853489?
The interventions under investigation include: recombinant bone morphogenetic protein 2 (DEVICE), Autogenous iliac crest bone graft (PROCEDURE).
Who is sponsoring clinical trial NCT00853489?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853489's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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