Comparison of INFIX and Plating for Pelvic Ring Injuries With Symphysis Disruptions
Status: | Terminated |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/27/2018 |
Start Date: | October 2014 |
End Date: | July 21, 2016 |
Prospective Randomized Comparison of Subcutaneous Internal Fixation ("INFIX") and Plating for Pelvic Ring Injuries With Symphysis Disruptions
The purpose of this study is to compare subcutaneous internal fixation and open plating of
the symphysis in patients with a disruption of the symphysis requiring stabilization.
the symphysis in patients with a disruption of the symphysis requiring stabilization.
The aim of this study is to determine whether either one of the two procedures has
significant advantages over the other. The null hypothesis of this study is that there is no
difference between plating and subcutaneous internal fixation of symphysis disruptions with
respect to primary and secondary outcomes. The study is a randomized trial with patients who
sustained a symphysis disruption who will randomize to either closed reduction and
subcutaneous internal fixation, or open reduction and plating of the symphysis. There will
also be two observational arms of the study, patients who do not agree to randomization and
will receive internal fixation according to the treating surgeon's discretion and patients
with a symphysis disruption that do not require any form of anterior pelvic internal fixation
based on the treating surgeon's opinion. Clinical assessments will occur at the time of
hospital admission and at all post-operative follow-up intervals (2 weeks, 6 weeks, 3 months,
6months, 12 months, and 24 months).
significant advantages over the other. The null hypothesis of this study is that there is no
difference between plating and subcutaneous internal fixation of symphysis disruptions with
respect to primary and secondary outcomes. The study is a randomized trial with patients who
sustained a symphysis disruption who will randomize to either closed reduction and
subcutaneous internal fixation, or open reduction and plating of the symphysis. There will
also be two observational arms of the study, patients who do not agree to randomization and
will receive internal fixation according to the treating surgeon's discretion and patients
with a symphysis disruption that do not require any form of anterior pelvic internal fixation
based on the treating surgeon's opinion. Clinical assessments will occur at the time of
hospital admission and at all post-operative follow-up intervals (2 weeks, 6 weeks, 3 months,
6months, 12 months, and 24 months).
Inclusion Criteria:
- A symphysis disruption either in the coronal and/or sagittal plane on
anterior-posterior , inlet and/or outlet pelvic radiographs
- Need for anterior pelvic ring stabilization
- Injury amenable to plating 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
Exclusion Criteria:
- 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
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