Study of Sacral Fractures Using Patient Based and Objective Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Sacrum Fracture

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Canada
  • Halifax, Canada
    • QEII Health Science Center-NHI
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Orthopaedic Associates of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Univerisity hospital
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73190
      • University of Oklahoma/ Health Science
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Orthopaedic Specialty Associates Fort Worth
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • University of Utah
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited through the Emergency Department or Orthopaedic Clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-Operative; Surgeon treated the patient non-operatively
Operative; Surgeon treated the patient operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Majeed Pelvic Score	Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
SMFA	Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
VAS	Obtained preoperatively and 24 hours, 1, 3, and 6 weeks 3, 6, 9, 12, and 24 month follow-ups

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiographic displacement	Union

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Foundation of Orthopedic Trauma
• Investigators: Principal Investigator: Paul Tornetta, MD, Boston University

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: November 25, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (ESTIMATE): November 26, 2008

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: H-27355