Clinical trial NCT00798733: Study of Sacral Fractures Using Patient Based and Objective Outcomes
Official title: A Multicenter Prospective Cohort Study of Sacral Fractures Using Patient Based and Objective Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sacrum Fracture
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Foundation of Orthopedic Trauma
First posted: 2008-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited through the Emergency Department or Orthopaedic Clinic

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Majeed Pelvic Score
timeFrame: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
measure: SMFA
timeFrame: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
measure: VAS
timeFrame: Obtained preoperatively and 24 hours, 1, 3, and 6 weeks 3, 6, 9, 12, and 24 month follow-ups
Secondary outcomes:
measure: Radiographic displacement
timeFrame: Union
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri-Univerisity hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma/ Health Science
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Fort Worth
country: United States
facility: Orthopaedic Specialty Associates Fort Worth
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Halifax
country: Canada
facility: QEII Health Science Center-NHI
Study officials:
affiliation: Boston University
name: Paul Tornetta, MD
role: PRINCIPAL_INVESTIGATOR
References: