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NCT01494519 · ClinicalTrials.gov registry record · Phase 3
Assessment of Fixation Strategies for Severe Open Tibia Fractures
A Phase 3 study, sponsored by Major Extremity Trauma Research Consortium.
- Completed
- Registry status
- Phase 3
- Development phase
- 442
- Enrollment target
NCT01494519: Completed Phase 3 study, sponsored by Major Extremity Trauma Research Consortium.
NCT01494519 is a Phase 3 study that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 442 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01494519, a Phase 3 study, has completed, sponsored by Major Extremity Trauma Research Consortium.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 442 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.
Primary Outcome
A hospital re-admission for a complication is defined as any re-admission to the hospital secondary to the treatment of the open tibia fracture for a defined set of complications. The list of complications includes: amputation (at any level), infection (defined using CDC criteria), flap failure, non-union, mal-union, loss of reduction, or hardware failure.
Interventions
- PROCEDURE Surgery with an external ring fixator
- PROCEDURE Definitive fixation with a locked IM nail or plate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2011-07 |
| Est. Completion | 2018-09 |
| Phase | Phase 3 |
What the finished NCT01494519 record still lists
NCT01494519 is an interventional study that assigns participants to a tested intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Surgery with an external ring fixator is the first listed.
NCT01494519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01494519 about?
NCT01494519 is a clinical study titled "Assessment of Fixation Strategies for Severe Open Tibia Fractures". The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.
What is the current status of trial NCT01494519?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 442 participants. The study started on 2011-07. Estimated completion is 2018-09.
What interventions are being tested in trial NCT01494519?
The interventions under investigation include: Surgery with an external ring fixator (PROCEDURE), Definitive fixation with a locked IM nail or plate (PROCEDURE).
Who is sponsoring clinical trial NCT01494519?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01494519's enrollment target sits among peer trials
442 867th of 2000 higher than 1,134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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