Clinical trial NCT02399319: Comparison of INFIX and Plating for Pelvic Ring Injuries With Symphysis Disruptions
Official title: Prospective Randomized Comparison of Subcutaneous Internal Fixation ("INFIX") and Plating for Pelvic Ring Injuries With Symphysis Disruptions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anterior Pelvic Ring Injury With Symphysis Disruption
Keywords: anterior pelvic ring
symphysis disruption
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Functional Outcomes
timeFrame: 24 hours - 24 months
Secondary outcomes:
measure: Compare the health-related quality of life and functional outcome scores
timeFrame: 24 hours - 24 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University Health
name: Michael Zlowodzki, MD
role: PRINCIPAL_INVESTIGATOR
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