Radius Distal FractureUDiReCTNCT03868696
Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT)
A study testing MUA with active ultrasound in people with Radius Distal Fracture and Colles' Fracture, run by Royal Devon and Exeter NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Distal Fracture, Colles' Fracture
- What is being tested?
- MUA with active ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Oct 2019to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with Colles' type fractures of the distal radius undergoing fracture manipulation in the ED
- UDiReCT Trial trained staff available
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Emergency Department
Exeter, Devon, EX2 5DW
Barking, Havering and Redbridge University Hospitals Nhs Trust
London
About this study
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.
Read the 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.
- Conditions
- Radius Distal Fracture, Colles' Fracture
- Being tested
- MUA with sham ultrasound, MUA with active ultrasound
- Keywords
- Ultrasound, Manipulation under anaesthesia, Emergency Department
- Medical subject headings
- Wrist Fractures, Colles' Fracture, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUA with sham ultrasoundProcedure or surgery
Standard MUA with sham ultrasound
MUA with active ultrasoundProcedure or surgery
Standard MUA guided by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| MUA with sham ultrasound | Sham comparator | Participants will undergo standard manipulation (MUA) of wrist fracture with sham ultrasound (screen concealed from participants) Receives: 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) Receives: Procedure: MUA with active ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment rate
Number of participants recruited over the duration of the study
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start7 Oct 2019
- Primary completion6 Apr 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radius Distal FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomised stratified by centre
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Emergency Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868696
- Sponsor's protocol ID
- 251149
- Acronym
- UDiReCT
- Status last verified
- Mar 2020
- First submitted
- 20 Feb 2019
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37890981
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT)
- ClinicalTrials.gov ID
- NCT03868696
- Acronym / sponsor ID
- UDiReCT / 251149
- Conditions
- Radius Distal Fracture, Colles' Fracture
- Keywords
- Ultrasound, Manipulation under anaesthesia, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal College of Emergency Medicine
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomised stratified by centre
| Arm | Type | Receives |
|---|---|---|
| MUA with sham ultrasound | Sham comparator | Procedure: MUA with sham ultrasoundParticipants will undergo standard manipulation (MUA) of wrist fracture with sham ultrasound (screen concealed from participants) |
| MUA with active ultrasound | Experimental | Procedure: MUA with active ultrasoundParticipants will undergo standard manipulation (MUA) of wrist fracture with active ultrasound (screen concealed from participants) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with Colles' type fractures of the distal radius undergoing fracture manipulation in the ED
- UDiReCT Trial trained staff available
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUA with sham ultrasoundStandard MUA with sham ultrasound | Procedure or surgery | MUA with sham ultrasound |
| MUA with active ultrasoundStandard MUA guided by ultrasound | Procedure or surgery | MUA with active ultrasound |
Primary outcome
Participant recruitment rate
Time frame: 6 months
Number of participants recruited over the duration of the study
1 secondary outcome
Data completeness.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Derived from this study: PubMed 37890981Malik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUA with active ultrasound in people with Radius Distal Fracture and Colles' Fracture, run by Royal Devon and Exeter NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03868696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.