- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01497080
Distal Radius Fracture Prospective Database 50-80 Years Old
March 18, 2014 updated by: Joy MacDermid, Lawson Health Research Institute
Distal Radius Fracture Prospective Database 50-80 Years Old Overview: "Identification of Risk of Adverse Activity Transition Following a Distal Radius Fracture".
The Problem Distal radius fractures (DRF) are common and result in a variable amount of disability.
The investigators have completed considerable work in developing tools that measure impairment and disability after DRF .
The investigators initial studies indicate that the associated disablement process is multifactorial and variable with only 25% of the resultant disability predicted by baseline patient and injury characteristics.
The investigators see DRF as a signal event where some people are at-risk of transitioning from an active lifestyle to inactivity and subsequent health risks.
The investigators recent data confirms variable participation following a DRF.
The traditional focus in orthopedic/rehabilitative approaches to DRF fracture management has been localized to the wrist, largely ignoring this potential transition and its health impacts.
The investigators will initiate a line of investigation that will profile the at-risk older adult who presents with a DRF with the ultimate goal of accurate identification and prevention of adverse activity transitions (active to inactive).
In this study the investigators will identify the extent of the problem by quantifying changes in activity/participation and its short-term health impacts.
The investigators will also identify the risk factors present at time of injury that predict a loss of mobility/activity/participation.
This work has the potential to identify tools and/or clinical prediction rules that identify at-risk individuals at a critical time where early intervention might most easily prevent adverse outcomes associated with inactivity.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
195
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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Ontario
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London, Ontario, Canada, N6A 4V2
- HULC, St Joseph's health Care London
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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
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participants aged 50-80 years of age who have incurred a wrist fracture
Description
Inclusion Criteria:
individuals 50-80 years old
- one month of fracture resulting from a fall from standing height or less will be recruited through our orthopedic surgeon
- wrist fracture
Exclusion Criteria:
previous history of humeral, hip or vertebral fracture
• Testing will not be performed on patients with evident postural instability, severe chronic conditions (Parkinson's disease) or other vestibulo-ocular abnormalities.
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
Cohorts and Interventions
Group / Cohort |
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1
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no treatment
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activity level
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joy MacDernmid, PhD, St. Joseph's Health Care London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Colquhoun HL, Letts LJ, Law MC, MacDermid JC, Missiuna CA. A scoping review of the use of theory in studies of knowledge translation. Can J Occup Ther. 2010 Dec;77(5):270-9. doi: 10.2182/cjot.2010.77.5.3.
- Grewal R, MacDermid JC, Pope J, Chesworth BM. Baseline predictors of pain and disability one year following extra-articular distal radius fractures. Hand (N Y). 2007 Sep;2(3):104-11. doi: 10.1007/s11552-007-9030-x. Epub 2007 Mar 23.
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
January 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
December 19, 2011
First Submitted That Met QC Criteria
December 21, 2011
First Posted (Estimate)
December 22, 2011
Study Record Updates
Last Update Posted (Estimate)
March 19, 2014
Last Update Submitted That Met QC Criteria
March 18, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18482
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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