NCT02353065

Brief Summary

Colles fractures are a common type of wrist fracture that often requires manipulation in the Emergency Department. Currently xrays are used to assess whether this has been successful, which are done once the plaster cast has been applied. This study will assess whether ultrasound can be used immediately after the manipulation to check the position, before the plaster cast is applied. This would then be followed by an xray as normal. The aim is to assess the feasibility of a full study to determine which method is faster, causes less pain, and also to assess if either approach reduces the need for repeat attempts at manipulation and surgical repair.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

1.4 years

First QC Date

January 25, 2015

Last Update Submit

January 28, 2015

Conditions

Colles' Fracture

Keywords

Colles' Fractureultrasonography

Outcome Measures

Primary Outcomes (1)

  • The total inflation time of the tourniquet used during the Biers Block

    The total inflation time of tourniquet used for Biers block

    The duration the tourniquet is inflated; complete within 30 minutes of the procedure commencing

Secondary Outcomes (5)

  • The total number of manipulations required per patient within the Emergency Department

    The duration of the manipulation procedure; complete within 30 minutes of procedure commencing

  • Does the use of ultrasound reduce the need for surgical reduction?

    Four weeks from visit

  • Does the use of ultrasound reduce the time spent within the Emergency Department?

    End of initial ED visit, within twelve hours of initial arrival to the hospital

  • Does the use of ultrasound reduce the pain score during the reduction?

    End of procedure - within 30 minutes of the procedure commencing

  • Does the use of ultrasound increase the patient satisfaction?

    Four weeks after visit

Study Arms (2)

Control

ACTIVE COMPARATOR

Assessment of adequacy of reduction by bedside x-ray during period of intravenous regional anaesthesia (Biers block)

Radiation: Bedside x-ray

Ultrasound

EXPERIMENTAL

Assessment of adequacy of reduction by bedside ultrasound performed by the treating clinician during period of intravenous regional anaesthesia (Biers block)

Procedure: Ultrasound imaging

Interventions

Ultrasound imagingPROCEDURE

Point of care ultrasound of fracture site during and post-reduction

Ultrasound
Bedside x-rayRADIATION

Portable x-ray of fracture post-reduction

Control

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with isolated fractures of the distal radius undergoing manipulation in the Emergency Department with Intravenous Regional Anaesthesia (Biers Block)

You may not qualify if:

  • Age under 16
  • Contraindication to Biers block
  • Unable to give informed consent
  • Multiple injuries
  • Open fracture
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Preston Hospital

Preston, Lancashire, PR2 9HT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colles' Fracture

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fracture DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesRadius FracturesFractures, Bone

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Simon Richards

    Teesside University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Richards

CONTACT

+44 1642 342589s.richards@tees.ac.uk

Michael Stewart

CONTACT

+44 7812 203011michael.stewart@lthtr.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer Medical Imaging (Ultrasound)

Study Record Dates

First Submitted

January 25, 2015

First Posted

February 2, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

GB(1)