Study of Sacral Fractures Using Patient Based and Objective Outcomes

NCT00798733 | Completed DMC

• 1 other identifier: H-27355
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 14

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.

Conditions

Sacrum Fracture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Radiographic displacement

  Union

Study Arms (2)

Non-Operative

Surgeon treated the patient non-operatively

Operative

Surgeon treated the patient operatively

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited through the Emergency Department or Orthopaedic Clinic

You may qualify if:

• \>=18 years old and \<=80 years old
• Unilateral sacral fractures
• Informed consent obtained
• Patient is English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• Foundation of Orthopedic Trauma: collaborator

Study Sites (14)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, 49503, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

University of Missouri-Univerisity hospital

Columbia, Missouri, 65212, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Oklahoma/ Health Science

Oklahoma City, Oklahoma, 73190, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Orthopaedic Specialty Associates Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Utah

Salt Lake City, Utah, 84103, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

QEII Health Science Center-NHI

Halifax, Canada

Location

Study Officials

• Paul Tornetta, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

CA (1); US (13)