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

Not Applicable

Terminated

• Conditions: Anterior Pelvic Ring Fractures
• Interventions: Procedure: External fixator; Procedure: Internal Fixator

• Registration Number: NCT02403154
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-08-11
• Results First Submitted QC: 2017-11-21
• Results First Posted: 2017-12-19
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized to External Fixator	External fixator	Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.
Randomized to Internal Fixator	Internal Fixator	Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.
Observational - External Fixator	External fixator	Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.
Observational - Internal Fixator	Internal Fixator	Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.

Primary Outcome Measures

Name	Time	Method
Functional Outcomes (PROMIS v1.2-Physical Function Instrument)	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 Outcome Measures

Name	Time	Method
Implant Breakage or Failure Rates	24 hours - 24 months	We will compare the implant failure/breakage rate between the two interventions.
Infection Rates	24 hours - 24 months	We will compare the rate of infection between the two interventions.
Revision Surgery Rates	24 hours - 24 months	We will compare the revision surgery rates between the two interventions.
Health-related Qualify of Life	24 hours - 24 months	We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: 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.
Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)	24 hours - 24 months	We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome
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	We will ask patients multiple questionnaires to asses their functional outcomes after surgery. These questionnaires include: 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.

Trial Locations

Locations (1)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States