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Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT) (UDiReCT)

Primary Purpose

Radius Distal Fracture, Colles' Fracture

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MUA with sham ultrasound
MUA with active ultrasound
Sponsored by
Royal Devon and Exeter NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Distal Fracture focused on measuring Ultrasound, Manipulation under anaesthesia, Emergency Department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Emergency Department
  • Barking, Havering and Redbridge University Hospitals Nhs Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

MUA with sham ultrasound

MUA with active ultrasound

Arm Description

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

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

Outcomes

Primary Outcome Measures

Participant recruitment rate
Number of participants recruited over the duration of the study

Secondary Outcome Measures

Data completeness.
The reliability and completeness of data proposed to be collected in a future definitive trial. Measured by the proportion of database fields completed by the end of the study

Full Information

First Posted
February 20, 2019
Last Updated
October 9, 2020
Sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborators
Royal College of Emergency Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03868696
Brief Title
Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT)
Acronym
UDiReCT
Official Title
Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
April 6, 2020 (Actual)
Study Completion Date
July 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborators
Royal College of Emergency Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Wrist fractures are one of the most common fractures encountered in the Emergency Department (ED). These injuries most frequently happen in people who have fallen onto an outstretched hand and can result in deformity ('displacement') of the broken bone. These 'displaced' (Colles' types of distal radial) fractures can result in long term deformity and problems using the wrist. To prevent this, patients with displaced fractures often undergo manipulation of their fractures, to straighten the wrist, using local anaesthetic or sedation techniques in ED before a plaster cast is applied. Unfortunately, if ED fracture manipulation is inadequate or the position later 'slips', which can occur in the first 1-2 weeks even in cast, then the patient will need to be admitted to hospital for surgical fixation. Local audit data suggests this affects up to a third of these patients and is a significant additional social and economic burden for patients and healthcare services. Reducing these fractures as precisely as possible might reduce the subsequent need for surgery. However, ED fracture manipulations are typically done 'blind' with check x-rays after casting, making re-manipulation time consuming with prolonged local anaesthetic times or need for re-sedation. Portable, bedside ultrasound is available in most departments and has been used to guide fracture reduction but it is not known how effective this is nor is it in routine use. Providing this evidence would require a large, multi-centre randomized controlled trial (RCT) trial. This project aims to determine whether such a trial comparing current practice with ultrasound guided reductions is justified and feasible. This will be done by running a feasibility RCT across two United Kingdom (UK) hospital sites to assess recruitment rates and trial procedures. The investigators hope to recruit about 60 patients in 6 months. This trial will include adults' aged 18 years and older, with Colles' type of distal radial fractures requiring manipulation in ED.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Distal Fracture, Colles' Fracture
Keywords
Ultrasound, Manipulation under anaesthesia, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomised stratified by centre
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MUA with sham ultrasound
Arm Type
Sham Comparator
Arm Description
Participants will undergo standard manipulation (MUA) of wrist fracture with sham ultrasound (screen concealed from participants)
Arm Title
MUA with active ultrasound
Arm Type
Experimental
Arm Description
Participants will undergo standard manipulation (MUA) of wrist fracture with active ultrasound (screen concealed from participants)
Intervention Type
Procedure
Intervention Name(s)
MUA with sham ultrasound
Intervention Description
Standard MUA with sham ultrasound
Intervention Type
Procedure
Intervention Name(s)
MUA with active ultrasound
Intervention Description
Standard MUA guided by ultrasound
Primary Outcome Measure Information:
Title
Participant recruitment rate
Description
Number of participants recruited over the duration of the study
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Data completeness.
Description
The reliability and completeness of data proposed to be collected in a future definitive trial. Measured by the proportion of database fields completed by the end of the study
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Emergency Department (ED) manipulation under anaesthesia (MUA) failure rate
Description
The proportion (%) of cases having undergone surgical fixation of the index fracture after ED MUA, within 6 weeks of injury . This is the proposed outcome for a definitive trial.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults with Colles' type fractures of the distal radius undergoing fracture manipulation in the ED UDiReCT Trial trained staff available Exclusion Criteria: 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
Facility Information:
Facility Name
Emergency Department
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Barking, Havering and Redbridge University Hospitals Nhs Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

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Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT)

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