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

Indiana University

Status: Terminated

Conditions: Anterior Pelvic Ring Fractures

Treatments: Procedure: External fixator; Procedure: Internal Fixator

Study type: Interventional

Funder types: Other

Identifiers

NCT02403154

1404651343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 4 patient groups

Randomized to Internal Fixator

Experimental group

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.

Treatment:

Procedure: Internal Fixator

Randomized to External Fixator

Experimental group

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.

Treatment:

Procedure: External fixator

Observational - Internal Fixator

Other group

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.

Treatment:

Procedure: Internal Fixator

Observational - External Fixator

Other group

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.

Treatment:

Procedure: External fixator