Comparison of Subcutaneous INFIX and EXFIX for Anterior Pelvic Ring Fractures Requiring Stabilization



Status:Terminated
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 120
Updated:4/17/2018
Start Date:April 2014
End Date:June 2016

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Prospective Randomized Comparison of Subcutaneous Internal Fixation and External Fixation for Anterior Pelvic Ring Fractures Requiring Stabilization

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.

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. This type of injury requires follow up at 2 weeks, 6 weeks, 3 months, 6 months, 12
months, and 24 months. At each follow up appointment, the patient will be asked to complete
surveys as part of the PROMIS series (Patient Reported Outcomes Measurement Information
System) which will include surveys about physical function, pain, mobility, sex life
satisfaction, depression, and for male patients, a survey about erectile function. In
addition to the PROMIS questionnaire for pain, the investigators will also use a visual
analogue pain scale and ask what the patient's satisfaction is on a scale of 0-100%. If the
patient does not report to clinic for follow up, the research coordinator will call the
patient to complete the study questionnaires.

Inclusion Criteria:

- 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

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
We found this trial at
1
site
Indianapolis, Indiana 46202
1868
mi
from 98109
Indianapolis, IN
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