Clinical trial NCT02403154: Comparison of Subcutaneous INFIX and EXFIX for Anterior Pelvic Ring Fractures Requiring Stabilization
Official title: Prospective Randomized Comparison of Subcutaneous Internal Fixation and External Fixation for Anterior Pelvic Ring Fractures Requiring Stabilization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anterior Pelvic Ring Fractures
Keywords: Anterior pelvic ring
Internal fixation
External fixation
Orthopaedic
Orthopedic
pubic rami
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Outcomes (PROMIS v1.2-Physical Function Instrument)
timeFrame: 24 hrs - 24 months
Secondary outcomes:
measure: Implant Breakage or Failure Rates
timeFrame: 24 hours - 24 months
measure: Infection Rates
timeFrame: 24 hours - 24 months
measure: Revision Surgery Rates
timeFrame: 24 hours - 24 months
measure: Health-related Qualify of Life
timeFrame: 24 hours - 24 months
measure: Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)
timeFrame: 24 hours - 24 months
measure: Compare the Functional Outcome Scores (PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction With Sex Life, PROMIS Depression, Majeed Score, SF-12, VAS, Patient Satisfaction Score, and (Only in Men) PROMIS Erectile Function)
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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