NCT01561573

Brief Summary

PURPOSE: to evaluate the utility of bedside ultrasound performed by emergency physicians in the evaluation and reduction of colles fractures as compared with traditional pre and post reduction radiographs. With the objectives of assessing Emergency Ultrasounds (EU) utility in guiding reduction attempts of Colles fractures and to compare EU to x-ray for the final assessment of reduction adequacy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

8 active sites

Status
unknown

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

March 16, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

March 16, 2012

Last Update Submit

April 21, 2012

Conditions

Keywords

Point of Care UltrasoundEmergency UltrasoundColles FractureFracture ReductionBedside Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Point of care ultrasound in Identifying colles fracture reduction

    Physicians performing Bedside ultrasound of colles fractures will be asked to complete likert scales on the adequacy of fracture reduction with ultrasound

    1 year

Secondary Outcomes (2)

  • Number of reduction attempts affected by ultrasound

    1 year

  • Time to imaging

    1 year

Study Arms (1)

Ultrasound colles fracture

OTHER

This is a single arm study

Device: Point of care ultrasound

Interventions

A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.

Also known as: Ultrasound Machines used in the study will include, Sonosite micromaxx, Sonosite M-Turbo, Ultrasonix Sonixtouch, Ultrasonix Sonixtablet, Esaote MyLab Five, Esaote MyLab 25 Gold
Ultrasound colles fracture

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 19 years old
  • Able to provide voluntary and informed consent
  • Distal radius fracture is the main traumatic injury
  • Planned reduction to be performed by the EP
  • Treating EP trained to perform EU for fractures OR one of the study authors available to perform EU

You may not qualify if:

  • \< 19 years old
  • Patient unable to provide voluntary and informed consent
  • Distal radius fracture is only one of several significant injuries
  • No reduction to be performed by the EP
  • EP not trained to perform EU for fractures AND no study author available to perform EU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Foothills Medical Center

Calgary, Alberta, T2N2T9, Canada

NOT YET RECRUITING

Namnaimo General Hospital

Nanaimo, British Columbia, V9S 2B7, Canada

NOT YET RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

Saint John Regional Hospital

Saint John, New Brunswick, E2L4L2, Canada

RECRUITING

St. John's Health Science Center

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

RECRUITING

Dartmouth General Hospital

Dartmouth, Nova Scotia, B2Y3S3, Canada

NOT YET RECRUITING

Sudbury Regional Hospital

Greater Sudbury, Ontario, P3E5J1, Canada

RECRUITING

Toronto East General Hospital

Toronto, Ontario, M4C3E7, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Colles' Fracture

Condition Hierarchy (Ancestors)

Fracture DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesRadius FracturesFractures, Bone

Study Officials

  • Andrew Skinner, MD

    St. Paul's Hospital

    PRINCIPAL INVESTIGATOR
  • Steve Socransky, MD

    Sudbury Regional Hospital

    STUDY DIRECTOR
  • Ray Wiss, MD

    Sudbury Regional Hospital

    STUDY DIRECTOR

Central Study Contacts

Andrew Skinner, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. William Andrew Skinner

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 23, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations