Status:

COMPLETED

Pelvic Ring Injury

Lead Sponsor:

Duke University

Collaborating Sponsors:

Orthopaedic Trauma Association

Prisma Health-Upstate

Conditions:

Pelvic Ring Injury

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of this study is to determine whether displacement on one or all of the standard radiography views done within 6 months and 1 year after a pelvic injury is related to health related qualit...

Detailed Description

This is a multicenter prospective investigation to assess the clinical outcomes of patients with an isolated pelvic ring injury. The study team plans on enrolling 60 subjects. This group will include ...

Eligibility Criteria

Inclusion

  • Subject is male or female age 18 year or older
  • Subject has an acute pelvic ring injury defined as sustaining fracture(s) and or dislocation(s) involving the continuity of the bony pelvic ring
  • Standard of Care CT scan and AP, Inlet, Outlet radiographs are performed done at baseline (admission)
  • Subject is willing and able to provide written informed consent for study participation with 14 days after pelvic injury
  • Subject is willing and able to comply with study protocol including return for all follow-up evaluations.

Exclusion

  • pre-existing or injury related spinal cord injuries
  • Pre-existing arthrosis of the Sacroiliac joints or Hip joints
  • Previous pelvic ring injury
  • Type IIIB or Type IIIC open fracture other than the pelvis injury
  • no CT scan done at baseline
  • Patient does not speak or read English
  • Patient is a prisoner or is at high risk of incarceration during the follow/up period
  • Subject is likely to have problems, in the judgment of the Investigator or Research Coordinator, with maintaining follow-up (such as no fixed address, plan to move out of town in the next year, etc.)

Key Trial Info

Start Date :

March 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2016

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01821339

Start Date

March 1 2013

End Date

April 1 2016

Last Update

July 27 2016

Active Locations (1)

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1

Duke University Medical Center

Durham, North Carolina, United States, 27707