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

NCT02399319 | Terminated DMC

• 1 other identifier: 1403899155
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Pelvic Ring Injury With Symphysis Disruption

Keywords

anterior pelvic ring; symphysis disruption

Outcome Measures

Primary Outcomes (1)

• Functional Outcomes

  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 Outcomes (1)

• Compare the health-related quality of life and functional outcome scores

  24 hours - 24 months

Study Arms (4)

Randomized to Internal Fixator

EXPERIMENTAL

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

Randomized to Symphyseal Plate

EXPERIMENTAL

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

Observational - Internal Fixator

ACTIVE COMPARATOR

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

Observational - Symphyseal Plate

ACTIVE COMPARATOR

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

Interventions

Internal Fixator PROCEDURE

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 - Internal Fixator; Randomized to Internal Fixator

Symphyseal Plate PROCEDURE

A plate that spans across the symphysis to maintain reduction and stability.

Observational - Symphyseal Plate; Randomized to Symphyseal Plate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (32)

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Related Links

• PROMIS outcome questionnaires

MeSH Terms

Interventions

Internal Fixators

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Michael Zlowodzki, MD

  Indiana University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: October 1, 2014
• Primary Completion: July 21, 2016
• Study Completion: July 21, 2016
• Last Updated: January 25, 2018

Record last verified: 2017-07

Locations

US (1)