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Clinical Trials/NCT04615104
NCT04615104
Recruiting
N/A

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

Wake Forest University Health Sciences1 site in 1 country200 target enrollmentJanuary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pelvic Fracture
Sponsor
Wake Forest University Health Sciences
Enrollment
200
Locations
1
Primary Endpoint
Return to work/activities
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 1, 2029
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Fracture of the pelvic ring
  • Fracture of the acetabulum

Exclusion Criteria

  • Patients unwilling to provide consent to participate.

Outcomes

Primary Outcomes

Return to work/activities

Time Frame: 0-24 months following injury

Average time to return to work and activities

Secondary Outcomes

  • Complications(0-24 months following injury)
  • Performance Measure- Five Time Sit to Stand Test(3, 6, 12 and 24 months)
  • Performance Measure- 10 meter walk test(3, 6, 12 and 24 months)
  • Performance Measure- Timed Up and Go Test(3, 6, 12 and 24 months)
  • Change in patient-reported outcomes measurement information system (PROMIS 29) scores(baseline, 3, 6, 12 and 24 months)
  • Fracture Healing(0-24 months following injury)

Study Sites (1)

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