Comparison of INFIX and Plating for Pelvic Ring Injuries With Symphysis Disruptions

January 22, 2018 updated by: Indiana University

Prospective Randomized Comparison of Subcutaneous Internal Fixation ("INFIX") and Plating for Pelvic Ring Injuries With Symphysis Disruptions

The purpose of this study is to compare subcutaneous internal fixation and open plating of the symphysis in patients with a disruption of the symphysis requiring stabilization.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to determine whether either one of the two procedures has significant advantages over the other. The null hypothesis of this study is that there is no difference between plating and subcutaneous internal fixation of symphysis disruptions with respect to primary and secondary outcomes. The study is a randomized trial with patients who sustained a symphysis disruption who will randomize to either closed reduction and subcutaneous internal fixation, or open reduction and plating of the symphysis. There will also be two observational arms of the study, patients who do not agree to randomization and will receive internal fixation according to the treating surgeon's discretion and patients with a symphysis disruption that do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion. Clinical assessments will occur at the time of hospital admission and at all post-operative follow-up intervals (2 weeks, 6 weeks, 3 months, 6months, 12 months, and 24 months).

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A symphysis disruption either in the coronal and/or sagittal plane on anterior-posterior , inlet and/or outlet pelvic radiographs
  • Need for anterior pelvic ring stabilization
  • Injury amenable to plating 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: Single Group Assignment
  • Masking: None (Open Label)

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 would 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 Symphyseal Plate
Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention would be internal plating of the symphysis.
Procedure: Symphyseal Plate
A plate that spans across the symphysis to maintain reduction and stability.
Active Comparator: Observational - Internal Fixator
Patient signed consent but did not want to randomize their procedure and the treating physician selected the internal fixator intervention based on their opinion of how best to treat the specific case.
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.
Active Comparator: Observational - Symphyseal Plate
Patient signed consent but did not want to randomize their procedure and the treating physician selected internal plating of the symphysis based on their opinion of how best to treat the specific case.
Procedure: Symphyseal Plate
A plate that spans across the symphysis to maintain reduction and stability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcomes
Time Frame: 24 hours - 24 months
The primary objective is to compare functional outcomes between subcutaneous internal fixation and symphyseal plating as measured by the PROMIS v1.2-Physical Function instrument.
24 hours - 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the health-related quality of life and functional outcome scores
Time Frame: 24 hours - 24 months
We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: PROMIS v1.1 - Pain Interference, PROMIS v1.2 - Mobility, PROMIS v1.0 - Global Satisfaction with Sex Life, PROMIS v1.0 - Depression, Majeed score, SF-12, VAS, patient satisfaction score, time to return to work, revision surgery, use of assistive walking devices, length of hospital stay, and for me, PROMIS v1.0 - 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

October 1, 2014

Primary Completion (Actual)

July 21, 2016

Study Completion (Actual)

July 21, 2016

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1403899155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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