- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868696
Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT) (UDiReCT)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom
- Barking, Havering and Redbridge University Hospitals NHS Trust
-
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Devon
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Exeter, Devon, United Kingdom, EX2 5DW
- Emergency department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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)
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Standard MUA with sham ultrasound
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Experimental: MUA with active ultrasound
Participants will undergo standard manipulation (MUA) of wrist fracture with active ultrasound (screen concealed from participants)
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Standard MUA guided by ultrasound
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant recruitment rate
Time Frame: 6 months
|
Number of participants recruited over the duration of the study
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Data completeness.
Time Frame: 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
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency Department (ED) manipulation under anaesthesia (MUA) failure rate
Time Frame: 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.
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6 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 251149
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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