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

Study Overview
=================
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.

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.

Official Title
-----------------
Prospective Randomized Comparison of Subcutaneous Internal Fixation and External Fixation for Anterior Pelvic Ring Fractures Requiring Stabilization

Conditions
-----------------
Anterior Pelvic Ring Fractures

Intervention / Treatment
-----------------
* Procedure: Internal Fixator
* Procedure: External fixator


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized to Internal Fixator<br>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<br>* 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.<br>|
| Experimental: Randomized to External Fixator<br>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<br>* 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.<br>|
| Other: Observational - Internal Fixator<br>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<br>* 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.<br>|
| Other: Observational - External Fixator<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Outcomes (PROMIS v1.2-Physical Function Instrument) | 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. | 24 hrs - 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Breakage or Failure Rates | We will compare the implant failure/breakage rate between the two interventions. | 24 hours - 24 months | 
| Infection Rates | We will compare the rate of infection between the two interventions. | 24 hours - 24 months | 
| Revision Surgery Rates | We will compare the revision surgery rates between the two interventions. | 24 hours - 24 months | 
| Health-related Qualify of Life | 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. | 24 hours - 24 months | 
| Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries) | We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome | 24 hours - 24 months | 
| 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) | 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. | 24 hours - 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior pelvic ring, Internal fixation, External fixation, Orthopaedic, Orthopedic, pubic rami