Sacrum Fracture Clinical Trial
Official title:
A Multicenter Prospective Cohort Study of Sacral Fractures Using Patient Based and Objective Outcomes
The purpose of this study is to define the outcomes, both patient based and radiographic, for sacral fractures based upon injury pattern, displacement, and treatment. This will aid the orthopaedist in determining the best course for those patients with mild to moderate displacement. Multiple centers will be included and not asked to change their protocols for management. The prospective evaluation will gather specific data points on mechanism of injury, displacements, position at union, and disease specific and general health outcomes.
There is wide variation in the current treatment of pelvic ring trauma. This divergence in
practice patterns includes the use of either operative or non-operative care for the same
fractures. Sacral fractures are the most commonly observed posterior pelvic ring injury and
comprise up to 75% of cases reported at most institutions. The optimal and appropriate
treatment of these fractures is vigorously debated despite the common goal of improving
patient outcomes. While significant posterior pelvic displacement is universally considered
an appropriate operative indication in healthy individuals, the threshold for "significant"
is poorly defined and difficulty to accurately measure. Further, lesser and minimal
displacement patterns are currently being treated operatively and non-operatively, depending
on the institution and the experience of the surgeon, and without adequate guidelines. This
lack of consensus in the treatment of sacral fractures is due to a poor understanding of
patient outcomes following operative and non-operative treatment, a poor understanding of how
the morbidities associated with a specific treatment affect patient outcome, and a lack of
data that allows any meaningful comparison of operative and non-operative treatment.
The purpose of this study is to define the patient-based and radiographic outcomes of sacral
fractures based on injury pattern, fracture displacement, and treatment method. We anticipate
that minimally displaced fractures will be treated non-operatively and significantly
displaced fractures will be treated operatively by most centers. There will also be a group
of patients with displacements that are treated operatively or non-operatively by different
surgeons. We will document the outcomes for all three groups, and compare the outcomes of
operative and nonoperative management for the middle (overlap) group. This will aid the
orthopaedist in determining the best treatment courser for those patients based on
displacement. Fourteen centers have agreed to participate with four already actively
recruiting. The prospective evaluation will gather specific data points on mechanism of
injury, displacements, position at union, and disease specific and general health outcomes.
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