Radius Fracture DistalNCT01497080
Distal Radius Fracture Prospective Database 50-80 Years Old
An observational study of Radius Fracture Distal, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Radius Fracture Distal
- How many people
- 195 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2014
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants aged 50-80 years of age who have incurred a wrist fracture
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Radius Fracture Distal
- Keywords
- distal radius fracture, Condition, risk factors, adverse activity transitions following DRF, optimal assessment approach
- Medical subject headings
- Wrist Fractures, Disease
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 |
|---|---|---|
| 1 | Not described | |
| activity level | Not described | |
| no treatment | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy MacDermid, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Joy MacDernmid, PhD, Principal investigator, St. Joseph's Health Care London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497080
- Sponsor's protocol ID
- 18482
- Status last verified
- Mar 2014
- First submitted
- 19 Dec 2011
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21268509Grewal 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.
PubMed 18780068
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Radius Fracture Prospective Database 50-80 Years Old Overview: "Identification of Risk of Adverse Activity Transition Following a Distal Radius Fracture".
- ClinicalTrials.gov ID
- NCT01497080
- Acronym / sponsor ID
- 18482
- Conditions
- Radius Fracture Distal
- Keywords
- distal radius fracture, Condition, risk factors, adverse activity transitions following DRF, optimal assessment approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Dec 2011 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| activity level | – | – |
| no treatment | – | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants aged 50-80 years of age who have incurred a wrist fracture
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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
Not reported in the source record.
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 19 Mar 2014.
- Background: PubMed 21268509Colquhoun 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.
- Background: PubMed 18780068Grewal 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.
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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.
Joy MacDernmid, PhD principal investigator
St. Joseph's Health Care London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radius Fracture Distal, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 2 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497080, which also lists 2 linked publications.
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 19 Mar 2014.