Expired Study
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Indianapolis, Indiana 46202


Purpose:

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 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. 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.


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


Study is Available At:


Original ID:

1404651343


NCT ID:

NCT02403154


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Principle Investigator left institution


Study Type:

Interventional


Study Design:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

4


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Zlowodzki, MD
Principal Investigator
Indiana University Health

Study Dates

Start Date:April 2014
Completion Date:June 2016
Completion Type:Actual
Primary Completion Date:June 2016
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 13, 2018
First Received Date:March 23, 2015
First Results Date:August 11, 2017

Study Outcomes

Outcome Type:Secondary Outcome
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)
Time Frame:24 hours - 24 months
Safety Issues:False
Description: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,
Outcome Type:Secondary Outcome
Measure:Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)
Time Frame:24 hours - 24 months
Safety Issues:False
Description:We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome
Outcome Type:Secondary Outcome
Measure:Health-related Qualify of Life
Time Frame:24 hours - 24 months
Safety Issues:False
Description: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, pat
Outcome Type:Secondary Outcome
Measure:Revision Surgery Rates
Time Frame:24 hours - 24 months
Safety Issues:False
Description:We will compare the revision surgery rates between the two interventions.
Outcome Type:Secondary Outcome
Measure:Infection Rates
Time Frame:24 hours - 24 months
Safety Issues:False
Description:We will compare the rate of infection between the two interventions.
Outcome Type:Secondary Outcome
Measure:Implant Breakage or Failure Rates
Time Frame:24 hours - 24 months
Safety Issues:False
Description:We will compare the implant failure/breakage rate between the two interventions.
Outcome Type:Primary Outcome
Measure:Functional Outcomes (PROMIS v1.2-Physical Function Instrument)
Time Frame:24 hrs - 24 months
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Procedure
Name:Internal Fixator
Description: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.
Arm Name:Randomized to Internal Fixator
Intervention Type:Procedure
Name:External fixator
Description: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.
Arm Name:Randomized to External Fixator

Study Arms

Study Arm Type:Other
Arm Name:Observational - External Fixator
Description: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.
Study Arm Type:Other
Arm Name:Observational - Internal Fixator
Description: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.
Study Arm Type:Experimental
Arm Name:Randomized to External Fixator
Description:Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.
Study Arm Type:Experimental
Arm Name:Randomized to Internal Fixator
Description:Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

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Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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