Pelvic and Acetabular Fracture: A Prospective Observational Study

Recruiting

• Conditions: Pelvic Fracture; Pubic Rami Fracture; Acetabular Fracture
• Interventions: Procedure: Operative; Procedure: Nonoperative

• Registration Number: NCT04615104
• Lead Sponsor: Wake Forest University Health Sciences

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2027-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Fracture of the pelvic ring
• Fracture of the acetabulum

Read More

Exclusion Criteria

• Patients unwilling to provide consent to participate.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acetabular Fracture	Nonoperative	Patients with acetabular fractures.
Acetabular Fracture	Operative	Patients with acetabular fractures.
Pelvic Ring Fracture	Operative	Patients with pelvic ring fractures.
Pelvic Ring Fracture	Nonoperative	Patients with pelvic ring fractures.

Primary Outcome Measures

Name	Time	Method
Return to work/activities	0-24 months following injury	Average time to return to work and activities

Secondary Outcome Measures

Name	Time	Method
Complications	0-24 months following injury	Rates of readmission, reoperations and complications
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- 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- 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.
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.

Trial Locations

Locations (1)

Atrium Health- Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States