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

Not Applicable

Terminated

• Conditions: Anterior Pelvic Ring Injury With Symphysis Disruption
• Interventions: Procedure: Symphyseal Plate; Procedure: Internal Fixator

• Registration Number: NCT02399319
• Lead Sponsor: Indiana University

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Primary Completion: 2016-07-21
• Study Completion: 2016-07-21
• Status Verified: 2017-07
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observational - Symphyseal Plate	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.
Observational - Internal Fixator	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.
Randomized to Internal Fixator	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.
Randomized to Symphyseal Plate	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.

Primary Outcome Measures

Name	Time	Method
Functional Outcomes	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.

Secondary Outcome Measures

Name	Time	Method
Compare the health-related quality of life and functional outcome scores	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.

Trial Locations

Locations (1)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States