ClinicalTrials.gg
CompletedNCT00798733Updated Sep 20, 2019

Study of Sacral Fractures Using Patient Based and Objective Outcomes

An observational study in Sacrum Fracture, sponsored by Boston Medical Center. Completed at 14 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-20.

Sponsored by Boston Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sacrum Fracture
03

In context

Lead sponsor

Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.

Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be recruited through the Emergency Department or Orthopaedic Clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)

Groups and cohorts

  • Non-Operative

    Surgeon treated the patient non-operatively

  • Operative

    Surgeon treated the patient operatively

06

What researchers measure

Primary outcomes

  1. Majeed Pelvic Score

    Time frame: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups

  2. SMFA

    Time frame: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups

  3. VAS

    Time frame: Obtained preoperatively and 24 hours, 1, 3, and 6 weeks 3, 6, 9, 12, and 24 month follow-ups

Secondary outcomes

  1. Radiographic displacement

    Time frame: Union

07

Study locations

14 sites
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • University of Michigan Hospital
    Ann Arbor, Michigan 48109, United States
  • Orthopaedic Associates of Michigan
    Grand Rapids, Michigan 49503, United States
  • Hennepin County Medical Center
    Minneapolis, Minnesota 55415, United States
  • University of Missouri-Univerisity hospital
    Columbia, Missouri 65212, United States
  • Barnes-Jewish Hospital
    St Louis, Missouri 63110, United States
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • University of Oklahoma/ Health Science
    Oklahoma City, Oklahoma 73190, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • Orthopaedic Specialty Associates Fort Worth
    Fort Worth, Texas 76104, United States
  • University of Utah
    Salt Lake City, Utah 84103, United States
  • Harborview Medical Center
    Seattle, Washington 98104, United States
  • QEII Health Science Center-NHI
    Halifax, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00798733
Collaborators
Foundation of Orthopedic Trauma
Responsible party
Sponsor
First posted
Nov 26, 2008
Start date
Oct 2008
Primary completion
Dec 2017
Completion
May 2019
Last update
Sep 20, 2019

Study contacts

Paul Tornetta, MD
principal investigator · Boston University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion