Sacrum FractureNCT00798733
Study of Sacral Fractures Using Patient Based and Objective Outcomes
An observational study of Sacrum Fracture, run by Boston Medical Center at 14 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sacrum Fracture
- How many people
- 100 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Oct 2008to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited through the Emergency Department or Orthopaedic Clinic
Who may be able to join
- >=18 years old and <=80 years old
- Unilateral sacral fractures
- Informed consent obtained
- Patient is English speaking
Who cannot join
- 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Boston Medical Center
Boston, Massachusetts, 02118
University of Missouri-Univerisity hospital
Columbia, Missouri, 65212
Ohio State University Medical Center
Columbus, Ohio, 43210
Orthopaedic Specialty Associates Fort Worth
Fort Worth, Texas, 76104
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49503
Indiana University
Indianapolis, Indiana, 46202
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University of Oklahoma/ Health Science
Oklahoma City, Oklahoma, 73190
Oregon Health & Science University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84103
Harborview Medical Center
Seattle, Washington, 98104
Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: 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.
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.
- Conditions
- Sacrum Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Operative | Surgeon treated the patient non-operatively | |
| Operative | Surgeon treated the patient operatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Majeed Pelvic Score
Measured: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
SMFA
Measured: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
VAS
Measured: Obtained preoperatively and 24 hours, 1, 3, and 6 weeks 3, 6, 9, 12, and 24 month follow-ups
Secondary outcomes (1)
Radiographic displacement
Measured: Union
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2017
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacrum FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Orthopedic Trauma
- Responsible party
- Sponsor
- Investigators
- Paul Tornetta, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798733
- Sponsor's protocol ID
- H-27355
- Status last verified
- Sep 2019
- First submitted
- 25 Nov 2008
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study of Sacral Fractures Using Patient Based and Objective Outcomes
- ClinicalTrials.gov ID
- NCT00798733
- Acronym / sponsor ID
- H-27355
- Conditions
- Sacrum Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Foundation of Orthopedic Trauma
- Study start
- Oct 2008
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Operative | – | –Surgeon treated the patient non-operatively |
| Operative | – | –Surgeon treated the patient operatively |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited through the Emergency Department or Orthopaedic Clinic
Key inclusion criteria (4 listed)
- >=18 years old and <=80 years old
- Unilateral sacral fractures
- Informed consent obtained
- Patient is English speaking
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Majeed Pelvic Score
Time frame: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
SMFA
Time frame: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups
VAS
Time frame: Obtained preoperatively and 24 hours, 1, 3, and 6 weeks 3, 6, 9, 12, and 24 month follow-ups
1 secondary outcome
Radiographic displacement
Time frame: Union
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Tornetta, MD principal investigator
Boston University
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacrum Fracture, run by Boston Medical Center at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Majeed Pelvic Score (time frame: Obtained preoperatively and at 3, 6, 9, 12, and 24 month follow-ups). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.