PACE: Pelvic and Acetabular Fracture: A Prospective Observational Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pelvic Ring Fracture Patients with pelvic ring fractures. |
Procedure: Operative
surgical treatment
Procedure: Nonoperative
nonsurgical treatment
|
| Acetabular Fracture Patients with acetabular fractures. |
Procedure: Operative
surgical treatment
Procedure: Nonoperative
nonsurgical treatment
|
Outcome Measures
Primary Outcome Measures
- Return to work/activities [0-24 months following injury]
Average time to return to work and activities
Secondary Outcome Measures
- Change in patient-reported outcomes measurement information system (PROMIS 29) scores [baseline, 3, 6, 12 and 24 months]
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.
- Fracture Healing [0-24 months following injury]
Union rates as measured clinically and radiographically. Xrays will be collected from the electronic medical record.
- Complications [0-24 months following injury]
Rates of readmission, reoperations and complications
- Performance Measure- 10 meter walk test [3, 6, 12 and 24 months]
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.
- Performance Measure- Five Time Sit to Stand Test [3, 6, 12 and 24 months]
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.
- Performance Measure- Timed Up and Go Test [3, 6, 12 and 24 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Fracture of the pelvic ring
-
Fracture of the acetabulum
Exclusion Criteria:
- Patients unwilling to provide consent to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atrium Health- Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Stephen Sims, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00082574
- 10-19-18E