Completed

Does Residual Displacement On Standard Radiographic Views Correlate With Pelvic Ring Injury Clinical Outcome?

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: March 2013
See protocol details

Summary

Principal SponsorDuke University
Last updated: July 27, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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 both patients treated with and without surgical repair of the pelvic ring injury. Concomitant injuries will be accounted in two ways first by tracking the patient's ISS (Injury Severity Score), second by tracking lower extremity fractures and lumbar spine injuries that require fixation. All patients will be enrolled within 2 weeks of injury to allow collection of outcome information asking the patients to score in a manner reflecting their perceived pre-injury level of function. The outcome instruments administered will include the short-musculoskeletal functional assessment (SMFA), the Oswestry Disability Score, Majeed Pelvis Score, and a visual analog pain score. Patient demographics including age, income level, educational level, family support, and work status will be recorded. Additional demographic information associated with motivation of recovery from injury will be collected at the time of enrollment. Associated aspects of the injury including neurologic, urologic, or bowel injuries associated with the injury will be documented. All operative complications or wound infections involving the care of the pelvic ring injury will also be recorded. Injury classification and operative data of surgical repair will also be collected. At time of follow-up neurologic deficits, evidence of painful hardware, limb length discrepancy will be documented. Initial radiographs and CT imaging will be taken in accordance with standard clinical care at participating centers. The decision for operative or non-operative management will be made at the discretion of the treating surgeon. At 6 months and 1 year follow-up time points, plain film radiographs including an AP Pelvis, 40 degree inlet and 40 degree outlet views will be made with a calibrated marker as described by Suzuki et al. Calibrated markers are available in standard clinical practice in Orthopaedic Surgery outpatient clinic radiology units. Use of the calibrated marker requires only that the marker, a metal ball 25mm in diameter, is included in the x-ray beam adjacent to the patient at the time of taking the radiograph. Radiographs are routine clinical practice at the follow-up time points in these patients. Outcome instruments will be administered to the patient at these time points as well.

Principal SponsorDuke University
Last updated: July 27, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Standard of Care CT scan and AP, Inlet, Outlet radiographs are performed done at baseline (admission)

Subject has an acute pelvic ring injury defined as sustaining fracture(s) and or dislocation(s) involving the continuity of the bony pelvic ring

Subject is male or female age 18 year or older

Subject is willing and able to comply with study protocol including return for all follow-up evaluations

Show More Criteria

8 exclusion criteria prevent from participating
Patient does not speak or read English

Patient is a prisoner or is at high risk of incarceration during the follow/up period

Pre-existing arthrosis of the Sacroiliac joints or Hip joints

Previous pelvic ring injury

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Duke University Medical Center

Durham, United StatesOpen Duke University Medical Center in Google Maps
CompletedOne Study Center