Colles' FractureSONARNCT02353065
Sonographic Assessment of Reduction in Colles' Fracture
A study testing Ultrasound imaging and Bedside x-ray in people with Colles' Fracture, run by Simon Richards at 1 site in United Kingdom.
Trial summary
Colles fractures are a common type of wrist fracture that often requires manipulation in the Emergency Department. Currently xrays are used to assess whether this has been successful, which are done once the plaster cast has been applied. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- Ultrasound imaging and Bedside x-ray
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jul 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults with isolated fractures of the distal radius undergoing manipulation in the Emergency Department with Intravenous Regional Anaesthesia (Biers Block)
Who cannot join
- Age under 16
- Contraindication to Biers block
- Unable to give informed consent
- Multiple injuries
- Open fracture
- Prisoners
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Preston Hospital
Preston, Lancashire, PR2 9HT
About this study
Colles fractures are a common type of wrist fracture that often requires manipulation in the Emergency Department. Currently xrays are used to assess whether this has been successful, which are done once the plaster cast has been applied. This study will assess whether ultrasound can be used immediately after the manipulation to check the position, before the plaster cast is applied. This would then be followed by an xray as normal.
The aim is to assess the feasibility of a full study to determine which method is faster, causes less pain, and also to assess if either approach reduces the need for repeat attempts at manipulation and surgical repair.
Read the detailed description
Fractures of the distal radius are a frequent cause for presentation to United Kingdom (UK) Emergency Departments, and the Colles' fracture is the most commonly encountered type. These injuries frequently occur in isolation, or associated with only minor injuries, and reduction of displaced fractures is typically performed by Emergency Physicians at the time of first attendance to the hospital.
The usually sequence of events is clinical examination, x-ray imaging to confirm the fracture, then the reduction is performed with appropriate analgesia or anaesthesia, the arm placed in a plaster backslab, and repeat imaging is taken to confirm adequacy of reduction. If the reduction is not satisfactory, repeat manipulation is required.
Haematoma block and Biers block permit x-ray imaging of the manipulated wrist while the anaesthetic action is still effective, permitting re-manipulation without further administration of local anaesthetic. Sedation is usually kept to as short a time as possible, and is not usually maintained while imaging is performed. There is usually some degree of delay while x-rays are taken and made available for viewing, and this wait prolongs the procedure for the patient and the treating clinician. In addition, Biers block cannot be tolerated for long by most patients, so any delay makes it less likely that a re-manipulation can be achieved within the time the patient can tolerate. If a patient has been sedated, a re-manipulation will require a further sedative (or alternative) procedure with the concomitant risks that entails.
Ideally, imaging would be performed rapidly, immediately at the end of the manipulation, prior to application of plaster, allowing confirmation of the reduction or immediate re-manipulation if necessary. This description of imaging provided at the point of care by the treating clinician, aimed at answering a clearly defined question ('is this an adequate reduction?') matches the description of focussed emergency ultrasound in other applications. If ultrasound could be used to assess fracture reduction, it would have potential to save clinician time, patient time and discomfort, and reduced the need for repeated manipulations and surgical repair.
This study intends to assess the feasibility of a full trial of efficacy comparing ultrasound with x-ray to guide the reduction of these fractures.
- Conditions
- Colles' Fracture
- Being tested
- Ultrasound imaging, Bedside x-ray
- Keywords
- Colles' Fracture, ultrasonography
- Medical subject headings
- Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imagingProcedure or surgery
Point of care ultrasound of fracture site during and post-reduction
Bedside x-rayRadiation
Portable x-ray of fracture post-reduction
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Assessment of adequacy of reduction by bedside x-ray during period of intravenous regional anaesthesia (Biers block) Receives: Radiation: Bedside x-ray |
| Ultrasound | Experimental | Assessment of adequacy of reduction by bedside ultrasound performed by the treating clinician during period of intravenous regional anaesthesia (Biers block) Receives: Procedure: Ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total inflation time of the tourniquet used during the Biers Block
The total inflation time of tourniquet used for Biers block
Measured: The duration the tourniquet is inflated; complete within 30 minutes of the procedure commencing
Secondary outcomes (5)
The total number of manipulations required per patient within the Emergency Department
Number of attempts at manipulation within Emergency Department
Measured: The duration of the manipulation procedure; complete within 30 minutes of procedure commencing
Does the use of ultrasound reduce the need for surgical reduction?
Need for surgical reduction/fixation
Measured: Four weeks from visit
Does the use of ultrasound reduce the time spent within the Emergency Department?
Total time spent within Emergency Department
Measured: End of initial ED visit, within twelve hours of initial arrival to the hospital
Does the use of ultrasound reduce the pain score during the reduction?
Patient reported pain score at the end of the fracture reduction
Measured: End of procedure - within 30 minutes of the procedure commencing
Does the use of ultrasound increase the patient satisfaction?
Patient reported satisfaction with reduction of fracture
Measured: Four weeks after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colles' 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Richards
- Sponsor type
- University, hospital or other
- Collaborators
- Lancashire Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Simon Richards, Teesside University
- Investigators
- Simon Richards, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353065
- Sponsor's protocol ID
- 141/13
- Acronym
- SONAR
- Status last verified
- Jan 2015
- First submitted
- 25 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Assessment of Reduction in Colles' Fracture
- ClinicalTrials.gov ID
- NCT02353065
- Acronym / sponsor ID
- SONAR / 141/13
- Conditions
- Colles' Fracture
- Keywords
- Colles' Fracture, ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Simon RichardsUniversity, hospital or other
- Collaborators
- Lancashire Teaching Hospitals NHS Foundation Trust
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- 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.
Colles fractures are a common type of wrist fracture that often requires manipulation in the Emergency Department. Currently xrays are used to assess whether this has been successful, which are done once the plaster cast has been applied. This study will assess whether ultrasound can be used immediately after the manipulation to check the position, before the plaster cast is applied. This would then be followed by an xray as normal.
The aim is to assess the feasibility of a full study to determine which method is faster, causes less pain, and also to assess if either approach reduces the need for repeat attempts at manipulation and surgical repair.
Detailed description
Fractures of the distal radius are a frequent cause for presentation to United Kingdom (UK) Emergency Departments, and the Colles' fracture is the most commonly encountered type. These injuries frequently occur in isolation, or associated with only minor injuries, and reduction of displaced fractures is typically performed by Emergency Physicians at the time of first attendance to the hospital.
The usually sequence of events is clinical examination, x-ray imaging to confirm the fracture, then the reduction is performed with appropriate analgesia or anaesthesia, the arm placed in a plaster backslab, and repeat imaging is taken to confirm adequacy of reduction. If the reduction is not satisfactory, repeat manipulation is required.
Haematoma block and Biers block permit x-ray imaging of the manipulated wrist while the anaesthetic action is still effective, permitting re-manipulation without further administration of local anaesthetic. Sedation is usually kept to as short a time as possible, and is not usually maintained while imaging is performed. There is usually some degree of delay while x-rays are taken and made available for viewing, and this wait prolongs the procedure for the patient and the treating clinician. In addition, Biers block cannot be tolerated for long by most patients, so any delay makes it less likely that a re-manipulation can be achieved within the time the patient can tolerate. If a patient has been sedated, a re-manipulation will require a further sedative (or alternative) procedure with the concomitant risks that entails.
Ideally, imaging would be performed rapidly, immediately at the end of the manipulation, prior to application of plaster, allowing confirmation of the reduction or immediate re-manipulation if necessary. This description of imaging provided at the point of care by the treating clinician, aimed at answering a clearly defined question ('is this an adequate reduction?') matches the description of focussed emergency ultrasound in other applications. If ultrasound could be used to assess fracture reduction, it would have potential to save clinician time, patient time and discomfort, and reduced the need for repeated manipulations and surgical repair.
This study intends to assess the feasibility of a full trial of efficacy comparing ultrasound with x-ray to guide the reduction of these fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Radiation: Bedside x-rayAssessment of adequacy of reduction by bedside x-ray during period of intravenous regional anaesthesia (Biers block) |
| Ultrasound | Experimental | Procedure: Ultrasound imagingAssessment of adequacy of reduction by bedside ultrasound performed by the treating clinician during period of intravenous regional anaesthesia (Biers block) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with isolated fractures of the distal radius undergoing manipulation in the Emergency Department with Intravenous Regional Anaesthesia (Biers Block)
Key exclusion criteria (6 listed)
- Age under 16
- Contraindication to Biers block
- Unable to give informed consent
- Multiple injuries
- Open fracture
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 |
|---|---|---|
| Ultrasound imagingPoint of care ultrasound of fracture site during and post-reduction | Procedure or surgery | Ultrasound |
| Bedside x-rayPortable x-ray of fracture post-reduction | Radiation | Control |
Primary outcome
The total inflation time of the tourniquet used during the Biers Block
Time frame: The duration the tourniquet is inflated; complete within 30 minutes of the procedure commencing
The total inflation time of tourniquet used for Biers block
5 secondary outcomes
The total number of manipulations required per patient within the Emergency Department
Time frame: The duration of the manipulation procedure; complete within 30 minutes of procedure commencing
Does the use of ultrasound reduce the need for surgical reduction?
Time frame: Four weeks from visit
Does the use of ultrasound reduce the time spent within the Emergency Department?
Time frame: End of initial ED visit, within twelve hours of initial arrival to the hospital
Does the use of ultrasound reduce the pain score during the reduction?
Time frame: End of procedure - within 30 minutes of the procedure commencing
Does the use of ultrasound increase the patient satisfaction?
Time frame: Four weeks after visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
Related trials for Colles' Fracture
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Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
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Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
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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.
Simon Richards principal investigator
Teesside University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound imaging and Bedside x-ray in people with Colles' Fracture, run by Simon Richards at 1 site 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Richards (+44 1642 342589, s.richards@tees.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total inflation time of the tourniquet used during the Biers Block (time frame: The duration the tourniquet is inflated; complete within 30 minutes of the procedure commencing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2015.