Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02403154
Recruitment Status : Terminated (Principle Investigator left institution)
First Posted : March 31, 2015
Results First Posted : December 19, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anterior Pelvic Ring Fractures Procedure: Internal Fixator Procedure: External fixator Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Subcutaneous Internal Fixation and External Fixation for Anterior Pelvic Ring Fractures Requiring Stabilization
Study Start Date : April 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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.

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.

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Implant Breakage or Failure Rates [ Time Frame: 24 hours - 24 months ]
    We will compare the implant failure/breakage rate between the two interventions.

  2. Infection Rates [ Time Frame: 24 hours - 24 months ]
    We will compare the rate of infection between the two interventions.

  3. Revision Surgery Rates [ Time Frame: 24 hours - 24 months ]
    We will compare the revision surgery rates between the two interventions.

  4. 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.

  5. 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

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403154


Locations
Layout table for location information
United States, Indiana
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Michael Zlowodzki, MD Indiana University Health

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT02403154    
Other Study ID Numbers: 1404651343
First Posted: March 31, 2015    Key Record Dates
Results First Posted: December 19, 2017
Last Update Posted: March 13, 2018
Last Verified: February 2018
Keywords provided by Indiana University:
Anterior pelvic ring
Internal fixation
External fixation
Orthopaedic
Orthopedic
pubic rami
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries