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

Sponsor

Royal Devon and Exeter NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT03868696

Collaborator

Royal College of Emergency Medicine (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Distal Fracture Colles' Fracture	Procedure: MUA with sham ultrasound Procedure: MUA with active ultrasound	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomised stratified by centre1:1 randomised stratified by centre

Masking:

Triple (Participant, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 7, 2019

Actual Primary Completion Date :

Apr 6, 2020

Actual Study Completion Date :

Jul 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: MUA with sham ultrasound Participants will undergo standard manipulation (MUA) of wrist fracture with sham ultrasound (screen concealed from participants)	Procedure: MUA with sham ultrasound Standard MUA with sham ultrasound
Experimental: MUA with active ultrasound Participants will undergo standard manipulation (MUA) of wrist fracture with active ultrasound (screen concealed from participants)	Procedure: MUA with active ultrasound Standard MUA guided by ultrasound

Arm

Intervention/Treatment

Sham Comparator: MUA with sham ultrasound

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

Procedure: MUA with sham ultrasound

Standard MUA with sham ultrasound

Experimental: MUA with active ultrasound

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

Procedure: MUA with active ultrasound

Standard MUA guided by ultrasound

Outcome Measures

Primary Outcome Measures

Participant recruitment rate [6 months]
Number of participants recruited over the duration of the study

Secondary Outcome Measures

Data completeness. [6 months]
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

Other Outcome Measures

Emergency Department (ED) manipulation under anaesthesia (MUA) failure rate [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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