NCT03868696

Brief Summary

This is a limited two centre randomized controlled feasibility trial towards a larger definitive trial designed to assess whether bed side ultrasound can reduce the rate of surgical fixation following emergency department manipulation of Colles' type wrist fractures. UDiReCT will mirror the proposed design of the definitive trial but will report feasibility data such as recruitment rate, data completeness and reliability of potential definitive trial outcome measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 20, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2020

Completed
Last Updated

October 12, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

February 20, 2019

Last Update Submit

October 9, 2020

Conditions

Radius Distal FractureColles' Fracture

Keywords

UltrasoundManipulation under anaesthesiaEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Participant recruitment rate

    Number of participants recruited over the duration of the study

    6 months

Secondary Outcomes (1)

  • Data completeness.

    6 months

Other Outcomes (1)

  • Emergency Department (ED) manipulation under anaesthesia (MUA) failure rate

    6 months

Study Arms (2)

MUA with sham ultrasound

SHAM COMPARATOR

Participants will undergo standard manipulation (MUA) of wrist fracture with sham ultrasound (screen concealed from participants)

Procedure: MUA with sham ultrasound

MUA with active ultrasound

EXPERIMENTAL

Participants will undergo standard manipulation (MUA) of wrist fracture with active ultrasound (screen concealed from participants)

Procedure: MUA with active ultrasound

Interventions

MUA with sham ultrasoundPROCEDURE

Standard MUA with sham ultrasound

MUA with sham ultrasound
MUA with active ultrasoundPROCEDURE

Standard MUA guided by ultrasound

MUA with active ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with Colles' type fractures of the distal radius undergoing fracture manipulation in the ED
  • UDiReCT Trial trained staff available

You may not qualify if:

  • Age under 18
  • Volar displaced (Smith's) type fractures (well established as being unstable and requiring surgical treatment)
  • Unable or unwilling to give informed consent
  • Unable or unwilling to be followed up (e.g. orthopaedic follow up in another region)
  • Major trauma with other injuries and ISS (Injury Severity Score) \>16
  • Urgent manipulation required due to neurovascular or skin compromise
  • Open fractures or those with associated nerve or tendon involvement (affect functional outcome)
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emergency Department

Exeter, Devon, EX2 5DW, United Kingdom

Location

Barking, Havering and Redbridge University Hospitals Nhs Trust

London, United Kingdom

Location

Related Publications (1)

  • Malik H, Wood D, Stone O, Gough A, Taylor G, Knapp KM, Heggs D, Appelboam A. Ultrasound Directed Reduction of Colles' type distal radial fractures in ED (UDiReCT): a feasibility randomised controlled trial. Emerg Med J. 2023 Nov 28;40(12):832-839. doi: 10.1136/emermed-2023-213279.

    PMID: 37890981DERIVED

MeSH Terms

Conditions

Wrist FracturesColles' FractureEmergencies

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneFracture DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesRadius FracturesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Sham ultrasound will be conducted in control group with screen off and facing away from participant. Active US screen will also be turned away from participant in the US allocated group and no discussion allowed about the image.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomised stratified by centre
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

March 11, 2019

Study Start

October 7, 2019

Primary Completion

April 6, 2020

Study Completion

July 6, 2020

Last Updated

October 12, 2020

Record last verified: 2020-03

Locations

GB(2)