Pelvic and Acetabular Fracture: A Prospective Observational Study

Study Overview
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Brief Summary
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The purpose of this study is to understand the trajectory of function and self-reported outcomes of patients following pelvic and acetabular, treated both operatively and nonoperatively.

Detailed Description
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The goal of the study study is to prospectively capture data from patients following pelvic and acetabular fractures, treated both operatively and nonoperatively, in order to understand the trajectory of functional and self-reported outcomes as well as to answer critical questions about treatment. Performance assessment data and patient-reported outcome measures utilizing the NIH PROMIS tool will be collected and analyzed for patients following pelvic or acetabular fracture, regardless of treatment.

Official Title
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Functional, Clinical, and Performance Outcomes Following Pelvic and Acetabular Fracture: A Prospective Observational Study

Conditions
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Pelvic Fracture, Acetabular Fracture, Pubic Rami Fracture

Intervention / Treatment
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* Procedure: Operative
* Procedure: Nonoperative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fracture of the pelvic ring Fracture of the acetabulum Exclusion Criteria: Patients unwilling to provide consent to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pelvic Ring Fracture<br>Patients with pelvic ring fractures. | Procedure: Operative<br>* surgical treatment<br>Procedure: Nonoperative<br>* nonsurgical treatment<br>|
| Acetabular Fracture<br>Patients with acetabular fractures. | Procedure: Operative<br>* surgical treatment<br>Procedure: Nonoperative<br>* nonsurgical treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work/activities | Average time to return to work and activities | 0-24 months following injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-reported outcomes measurement information system (PROMIS 29) scores | The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome. | baseline, 3, 6, 12 and 24 months | 
| Fracture Healing | Union rates as measured clinically and radiographically. Xrays will be collected from the electronic medical record. | 0-24 months following injury | 
| Complications | Rates of readmission, reoperations and complications | 0-24 months following injury | 
| Performance Measure- 10 meter walk test | Participants complete a modified 10 meter walk test which involves the subject starting from a standing position, walking 5 meters at a comfortable pace, turning around, and then walking back 5 meters to the original starting point. The test is repeated twice for each subject. | 3, 6, 12 and 24 months | 
| Performance Measure- Five Time Sit to Stand Test | Participants begin from a seated position and are directed to come to a full standing position without push off assistance from upper extremities and then return to a seated position without upper extremity assist. | 3, 6, 12 and 24 months | 
| Performance Measure- Timed Up and Go Test | Participants begin in a seated position. They are directed to stand and walk 3 meters to a cone on the floor. They are to round the cone in a continuous motion, walk back to the chair, turn again and be seated. The entire test is performed at a comfortable and safe speed for the patient. | 3, 6, 12 and 24 months |