Pelvic Ring Injury Clinical Trial
Official title:
Does Residual Displacement On Standard Radiographic Views Correlate With Pelvic Ring Injury Clinical Outcome?
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.
;
Observational Model: Case-Only, Time Perspective: Prospective