Study of Sacral Fractures Using Patient Based and Objective Outcomes

Sacrum Fracture Clinical Trial

Official title:

A Multicenter Prospective Cohort Study of Sacral Fractures Using Patient Based and Objective Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798733
• Other study ID #: H-27355
• Status: Completed
• Start date: October 2008
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Sacrum Fracture

Locations

Country	Name	City	State
Canada	QEII Health Science Center-NHI	Halifax
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Boston Medical Center	Boston	Massachusetts
United States	University of Missouri-Univerisity hospital	Columbia	Missouri
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Orthopaedic Specialty Associates Fort Worth	Fort Worth	Texas
United States	Orthopaedic Associates of Michigan	Grand Rapids	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of Oklahoma/ Health Science	Oklahoma City	Oklahoma
United States	Oregon Health & Science University	Portland	Oregon
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Foundation of Orthopedic Trauma

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Majeed Pelvic Score		Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
Primary	SMFA		Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
Primary	VAS		Obtained preoperatively and 24 hours, 1, 3, and 6 weeks 3, 6, 9, 12, and 24 month follow-ups
Secondary	Radiographic displacement		Union