Sacrum Fracture Clinical Trial
Official title:
A Multicenter Prospective Cohort Study of Sacral Fractures Using Patient Based and Objective Outcomes
NCT number | NCT00798733 |
Other study ID # | H-27355 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2008 |
Est. completion date | May 2019 |
Verified date | September 2019 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | Foundation of Orthopedic Trauma |
United States, Canada,
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 |