Prospective Randomized Comparison of Subcutaneous Internal Fixation and External Fixation for Anterior Pelvic Ring Fractures Requiring Stabilization
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anterior Pelvic Ring Fractures
- Sponsor
- Indiana University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Functional Outcomes (PROMIS v1.2-Physical Function Instrument)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Functional Outcomes (PROMIS v1.2-Physical Function Instrument)
Time Frame: 24 hrs - 24 months
The primary objective is to compare functional outcomes between subcutaneous internal fixation and external fixation as measured by the PROMIS v1.2-Physical Function instrument.
Secondary Outcomes
- Implant Breakage or Failure Rates(24 hours - 24 months)
- Infection Rates(24 hours - 24 months)
- Revision Surgery Rates(24 hours - 24 months)
- Health-related Qualify of Life(24 hours - 24 months)
- Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)(24 hours - 24 months)
- 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)(24 hours - 24 months)