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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
| Prisma Health-Upstate | OTHER |
| Wake Forest University Health Sciences | OTHER |
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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 quality of life outcomes of patients with an isolated pelvic ring injury.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in displacement on one or all of the standard radiographic views | Participants will be scheduled for Standard of Care follow ups at 6 months and 1 year where x-rays will be taken to assess the fracture | 6 months and 1 year after injury |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health related quality of life outcomes | Questionnaires (short-musculoskeletal functional assessment (SMFA), SF-12, the Oswestry Disability Score, Majeed Pelvis Score, and a visual analog pain score) will help the study team understand participant progress. | Enrollment, 6 months and 1 year follow up |
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Inclusion Criteria:
Exclusion Criteria:
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Urgent care patients. Patients coming to the ER with a Pelvic ring Fx
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| Name | Affiliation | Role |
|---|---|---|
| Steven Olson, MD | Duke University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27707 | United States |
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