NCT01497080

Brief 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 . 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

December 19, 2011

Last Update Submit

March 18, 2014

Conditions

Keywords

distal radius fractureConditionrisk factorsadverse activity transitions following DRFoptimal assessment approach

Study Arms (3)

1

activity level

no treatment

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants aged 50-80 years of age who have incurred a wrist fracture

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HULC, St Joseph's health Care London

London, Ontario, N6A 4V2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 21268509BACKGROUND
  • 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.

    PMID: 18780068BACKGROUND

MeSH Terms

Conditions

Wrist FracturesDisease

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BonePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joy MacDernmid, PhD

    St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 22, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations