- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00888160
Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care
May 8, 2018 updated by: Heather A. Vallier, MetroHealth Medical Center
Early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some complication rates.
However, in patients with multiple injuries, the optimal treatment of skeletal trauma may be affected by severe injury to the head, chest, or abdomen.
The relationship between associated injury severity and the timing of definitive management of unstable fractures is not well-understood.
The practice of "early total care," early definitive fracture management, has been criticized by some, who have suggested that additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory response.
The alternative extreme of "damage control orthopedics (DCO)" has been recently proposed as a means of providing provisional stability of major skeletal injury, generally through external fixation.
It is speculated that DCO will diminish the potential for systemic compromise.
However, the need for further (definitive) surgery on a delayed basis, and the potential additional complications and costs associated with this strategy are controversial.
The investigators' goals are to define which injuries or parameters warrant delay of definitive orthopaedic care, and to determine what time interval for fracture fixation promotes optimal patient outcome.
The investigators will assess the effects of fracture fixation on head injury, chest injury, abdominal injury, mortality, complications, patient outcomes, and costs.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries: unstable pelvic ring fracture, unstable acetabulum fracture, or femur fracture.
Description
Inclusion Criteria:
All patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries:
- unstable pelvic ring fracture
- unstable acetabulum fracture, or
- femur fracture
- Patients will be included regardless of race or gender. Isolated fractures will be included
Exclusion Criteria:
- Low-energy pelvis and hip fractures will be excluded
- Patients younger than 16 years of age will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2010
Primary Completion (Actual)
October 1, 2017
Study Completion
January 1, 2031
Study Registration Dates
First Submitted
April 24, 2009
First Submitted That Met QC Criteria
April 24, 2009
First Posted (Estimate)
April 27, 2009
Study Record Updates
Last Update Posted (Actual)
May 14, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB06-00089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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