Study of Sacral Fractures Using Patient Based and Objective Outcomes



Status:Active, not recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:1/13/2019
Start Date:October 2008
End Date:June 2019

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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.

Inclusion Criteria:

- >=18 years old and <=80 years old

- Unilateral sacral fractures

- Informed consent obtained

- Patient is English speaking

Exclusion Criteria:

- APC injuries

- Zone 3 sacral fractures

- Unable to comply with outcome measures, postoperative rehabilitation protocols or
instructions (e.g. head injured or mentally impaired)

- Unlikely to follow-up in surgeon's estimation

- Incarcerated
We found this trial at
14
sites
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mi
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Columbia, MO
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Brian Mullis, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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mi
from
Indianapolis, IN
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Darin Friess, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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mi
from
Portland, OR
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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mi
from
Salt Lake City, UT
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Ann Arbor, Michigan 48109
Principal Investigator: Jim Goulet, MD
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mi
from
Ann Arbor, MI
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Boston, Massachusetts 02118
Principal Investigator: Paul Tornetta, MD
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Boston, MA
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Columbus, Ohio 43210
Principal Investigator: Laura Phieffer, MD
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mi
from
Columbus, OH
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Fort Worth, Texas 76104
Principal Investigator: Cory Collinge, MD
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mi
from
Fort Worth, TX
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Grand Rapids, Michigan 49525
Principal Investigator: Cliff Jones, MD
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Grand Rapids, MI
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mi
from
Halifax,
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Minneapolis, Minnesota 55414
Principal Investigator: Andy Schmidt, MD
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mi
from
Minneapolis, MN
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Oklahoma City, Oklahoma 73190
Principal Investigator: Dave Teague, MD
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mi
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Oklahoma City, OK
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Saint Louis, Missouri 63110
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mi
from
Saint Louis, MO
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Sean Nork, MD
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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mi
from
Seattle, WA
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