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

February 13, 2018 updated by: Indiana University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Randomized to 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.
Procedure: Internal Fixator
Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally.
Experimental: Randomized to 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.
Procedure: External fixator
External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body.
Other: Observational - 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.
Procedure: Internal Fixator
Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally.
Other: Observational - 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.
Procedure: External fixator
External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hrs - 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Breakage or Failure Rates
Time Frame: 24 hours - 24 months
We will compare the implant failure/breakage rate between the two interventions.
24 hours - 24 months
Infection Rates
Time Frame: 24 hours - 24 months
We will compare the rate of infection between the two interventions.
24 hours - 24 months
Revision Surgery Rates
Time Frame: 24 hours - 24 months
We will compare the revision surgery rates between the two interventions.
24 hours - 24 months
Health-related Qualify of Life
Time Frame: 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.
24 hours - 24 months
Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)
Time Frame: 24 hours - 24 months
We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome
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)
Time Frame: 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.
24 hours - 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Michael Zlowodzki, MD, Indiana University Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404651343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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