Comparison of Subcutaneous INFIX and EXFIX for Anterior Pelvic Ring Fractures Requiring Stabilization
Stopped early · Not applicable
Conditions studied: Anterior Pelvic Ring Fractures
In brief
The purpose of this research is to compare patient outcomes of two treatment methods that are currently used as standard of care to treat anterior pelvic ring injuries that require stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and external fixation (EXFIX). Patients will be given the opportunity to opt out of randomization and participate in one of the observational arms. The first observational arm is comprised of those patients who do not want to randomize and they will undergo anterior pelvic ring stabilization according to the treating surgeon's discretion. The second observational arm will be comprised of patients who consent to be in the study but whose pelvic ring fractures do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion.
Key facts
- Study ID
- NCT02403154
- Run by
- Indiana University
- People needed
- 4
- Starts
- 2014-04-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2018-03-13
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- One or more fractures of the anterior pelvic ring (pubic rami)
- Need for anterior pelvic ring stabilization
- Injury amenable to external as well as subcutaneous internal fixation per the treating surgeon's opinion
- Patient was ambulatory prior to sustaining the injury
- Provision of informed consent by patient or proxy
You may not qualify if…
- Patients with a slim build with little subcutaneous fat who cannot be treated with a subcutaneous internal fixator based on the treating surgeon's opinion
- Patients who are deemed not likely to follow-up (e.g. patients who live more than 50 miles away and patients with no fixed address)
- Moderately or severely cognitively impaired patients
- Pregnant women
- Prisoners
Where it is running
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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