Sacral Fractures


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Sacral Fracture Outcomes
1. IMPRESS	Status	Steering Committee	Study Materials	Jump To
2. SOLVED	Open and Enrolling	Mo Bhandari	Protocol_V3	Summary
3. rhBMP-2		Jim Goulet	Forms	Research Design
4. Femur Outcomes		Cliff Jones	Protocol_V3_TrackChanges	Outcomes
5. Damage Control	Study Registration	Sean Nork		Inclusion Criteria
6. Sacral Fractures	NCT00798733	Dave Templeman		Exclusion Criteria
7. Ankle Plating		Paul Tornetta
8. Scapula Fractures

Title A Multicenter Prospective Cohort Study of Sacral Fractures Using Patient Based and Objective Outcomes. Summary 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 among the most common pelvic injuries, comprising 75% of all those seen at most centers. The appropriate treatment of this fracture is vigorously debated despite the common goal of improving patient outcomes. While significant displacement is a universal operative indication in healthy individuals, lesser degrees of displacement are treated operatively and nonoperatively. The lack of consensus in the treatment of sacral fractures is due to a poor understanding of patient outcomes following following operative and nonoperative treatment, a poor understanding of how the morbidities associated with a specific treatments affect patient outcome, and a lack of data that prevents any meaningful comparison of operative and non-operative treatment. The purpose of this study is to define the outcomes, both patient based and radiographic, for sacral fractures based upon injury pattern, displacment, 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. [return to top] Research Design This project will be a prospective observational cohort study of all unilateral sacral fractures seen across 20+ trauma centers. Inclusion criteria will be all patients 18 – 80 yo with unilateral sacral fractures. Patients unable to comply with outcome measures, prisoners, pregnant women, those with APC injuries, Zone 3 sacral fractures, and those unable to comply with followup will be excluded. As there is substantial variation in the treatment protocols between centers, the study will be designed as observational, with comparisons of outcomes for similar injuries being performed apriori after the study is complete. In particular, there is interest in evaluating the VAS and outcomes data for “minimally” displaced fractures treated operatively and nonoperatively. Minimally displaced will be defined as less than 8mm displacement of the sacrum. Thus, operative and nonoperative cases will be included. All patients will follow the same postoperative protocol if possible based on additional injuries. Multiple trauma patients will be included. Data on operative cases will be gathered including the method of reduction, the implants utilized posteriorly and anteriorly. [return to top] Outcomes Baseline information on each awake and alert patient will be obtained during their initial hospitalization. The Majeed pelvic score, the SMFA, MMSE, and a visual analog scale for pain (0-10) will be utilized. The VAS pain will be obtained within the first 24 hours, at 7-10 days, and at 21 ± 7 days in addition to all scheduled follow-ups. The validated outcome scores will be obtained at the initial hospitalization, the 3 month, 6 month, 9 month, 12 month, and if available, the 24 month followup. [return to top] Inclusion Criteria >=18 years old and <=80 years old Unilateral sacral fractures Informed consent obtained Patient is English speaking [return to top] Exclusion Criteria: APC injuries Zone 3 sacral fractures Displaced Acetabular fracture Pregnant Women 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 [return to top]