Colles' FracturePREDICTNCT03859999
PRediction of Outcome With ED Intervention for Colles Type Wrist Fractures [PREDICT]
An observational study of Colles' Fracture and Colles' Fracture of Unspecified Radius, Sequela, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The Colles fracture, a fracture of the wrist, is frequently associated with deformity of the broken part of the bone, particularly in older or frail patients. This can cause long term wrist deformity and problems using the wrist and hand if not corrected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colles' Fracture, Colles' Fracture of Unspecified Radius, Sequela
- What is being tested?
- Analysis of primary radiograph and available demographics
- How many people
- 279 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 1 May 2018
- Phase
- Observational
- 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
Study population: Cases identified from a previously conducted clinical activity analysis of patients who had undergone MUA for Colles' fracture over a two year period at Royal Devon and Exeter Hospital ED. These cases were retrospectively identified (from electronic attendance logs) and followed up until fracture healing or surgery. In this database, the need for subsequent surgery was recorded from electronic records and review of comments in fracture clinic. X-rays of these patients have been identified and anonymised by a member of staff, who is not a member of the research team. These X-rays and the database cases have been given a unique trial number and all identifiable data removed before trial use.
Who may be able to join
- All Adult patients who have under gone a planned ED MUA for a distal radial fracture over a two year period (anonymous data from a previously conducted service evaluation)
Who cannot join
- Smiths' (volarly displaced) fractures
- Those for whom there is no follow up data in the database eg. Patients who were followed up elsewhere.
- Open (compound) fractures (need open surgery to wash out and treat)
- Fractures requiring emergency manipulation due to threatened skin or neurovascular compromise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Failure of Emergency Department Closed Manipulation of Colles' Distal Radial Fractures
The Colles fracture, a fracture of the wrist, is frequently associated with deformity of the broken part of the bone, particularly in older or frail patients. This can cause long term wrist deformity and problems using the wrist and hand if not corrected.
Manipulation under anaesthesia (MUA) is often undertaken in the emergency department (ED) for 'displaced' fractures in an attempt to correct the deformity. The procedure involves a local anaesthetic technique, additional staff, and takes some time to complete. The procedure is not without risk; it can cause bruising, skin tears, complications from the local anaesthetic and can be uncomfortable.
Read more
Although fracture positions are usually improved by ED manipulation initially; these fractures can slip back to an unacceptable position over the next 1-2 weeks, despite plaster cast immobilisation. For fractures that slip, open surgery is usually required to correct and hold the fracture with metal plates or wires. This is performed in the operating theatre and requires another visit to the hospital. Preliminary work suggests this affects over a quarter of patients, undergoing ED MUA for Colles' wrist fractures.
If it were possible to reliably identify patients whose fractures were likely to slip and require open surgery despite ED manipulation, unnecessary procedures and visits to hospital could be avoided. This would ensure patients got the right treatment first time and save patients and the NHS time and money.
There are a number of factors that might affect the likelihood of fracture instability and need for surgery. These include patient factors such as age, functional status and presence of osteoporosis (thin weak bones) and the specific position of the fracture. In this study we will be measuring the fracture positions on x-rays of patients with a Colles' fracture to see if we can accurately predict ED MUA failure on the initial x-ray.
Read the detailed description
Many thousands of patients attend emergency departments (ED) with displaced (deformed) wrist fractures and undergo closed manipulation under local anaesthetic (MUA) in the ED. Local audit suggests between 25-40% of these manipulated fractures slip back into an unacceptable position (unstable fractures) and require a subsequent open operation to reduce and pin or plate the bone (ORIF). There is some evidence that the degree of initial deformity and other factors might predict instability but this is neither well established nor well researched. Reliably predicting which fractures are likely to fail and which are likely to succeed closed ED manipulation could reduce the proportion undergoing a futile ED procedure, save patients' time and visits to hospital and ensure definitive care the first time round.
We will identify cases from a previously conducted clinical activity analysis of patients who had undergone MUA for Colles' fracture over a two year period at Royal Devon and Exeter Hospital ED. These cases were retrospectively identified (from electronic attendance logs) and followed up until fracture healing or surgery. In this database, the need for subsequent surgery was recorded from electronic records and review of comments in fracture clinic. X-rays of these patients have been identified and anonymised by a member of radiology staff, who is not a member of the research team. These X-rays and the database cases have been given a unique trial number and all identifiable data removed before trial use. The database will be used to provide outcome data for the development of a model to see if x-ray features can reliably predict ED MUA failure. We will exclude Smiths' (anteriorly displaced) fractures and those whom there is no follow up data in the database eg. Patients who were followed up elsewhere.
Anonymised x-rays will be used to develop computer-assisted methods to measure key fracture angles as well as other factors such as degree and position of comminution (fragmentation) and markers of osteoporosis. All x-rays will then by analysed using the system to record these measurements. Depending upon the speed of development, any user facing systems could also be tested on staff to gauge usability and test for inter-rater agreement.
Multivariate analysis of these x-ray features measured by computer, together with the database demographic and outcome data will be used to develop the best model /decision rule to predict likelihood of MUA success. A 'leave one out cross validation' technique will be used to validate such a model and assess whether we could have reduced the ED MUA failure rate without increasing the overall number of open operative procedures. This work will be used to inform a larger prospective study where any decision rules can be assessed and further factors explored with the prospect of adding these to any final computer model.
- Being tested
- Analysis of primary radiograph and available demographics
- Keywords
- Colles' Fracture, Distal radial fracture, Manipulation under anaesthesia (MUA), Emergency Department
- Medical subject headings
- Colles' Fracture, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of primary radiograph and available demographicsDiagnostic test
Multivariate analysis of the fracture x-ray features measured by computer, together with the database demographic and outcome data will be used to develop the best model /decision rule to predict likelihood of MUA success
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsequent surgery
Subsequent open surgery performed due to unsatisfactory fracture position following ED fracture manipulation
Measured: 6 weeks
Secondary outcomes (1)
Unsatisfactory position and recommended surgery
The subsequent occurrence of an unsatisfactory fracture position after ED manipulation as determined by the treating orthopaedic surgeon such that surgery is recommended
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Nov 2017
- Primary completion1 Feb 2018
- Study completion1 May 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter, City, University of London
- Responsible party
- Sponsor
- Investigators
- Andrew Appelboam, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859999
- Sponsor's protocol ID
- 1802595
- Acronym
- PREDICT
- Status last verified
- Feb 2019
- First submitted
- 28 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Failure of Emergency Department Closed Manipulation of Colles' Distal Radial Fractures
- ClinicalTrials.gov ID
- NCT03859999
- Acronym / sponsor ID
- PREDICT / 1802595
- Keywords
- Colles' Fracture, Distal radial fracture, Manipulation under anaesthesia (MUA), Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter, City, University of London
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 1 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.
The Colles fracture, a fracture of the wrist, is frequently associated with deformity of the broken part of the bone, particularly in older or frail patients. This can cause long term wrist deformity and problems using the wrist and hand if not corrected.
Manipulation under anaesthesia (MUA) is often undertaken in the emergency department (ED) for 'displaced' fractures in an attempt to correct the deformity. The procedure involves a local anaesthetic technique, additional staff, and takes some time to complete. The procedure is not without risk; it can cause bruising, skin tears, complications from the local anaesthetic and can be uncomfortable.
Although fracture positions are usually improved by ED manipulation initially; these fractures can slip back to an unacceptable position over the next 1-2 weeks, despite plaster cast immobilisation. For fractures that slip, open surgery is usually required to correct and hold the fracture with metal plates or wires. This is performed in the operating theatre and requires another visit to the hospital. Preliminary work suggests this affects over a quarter of patients, undergoing ED MUA for Colles' wrist fractures.
If it were possible to reliably identify patients whose fractures were likely to slip and require open surgery despite ED manipulation, unnecessary procedures and visits to hospital could be avoided. This would ensure patients got the right treatment first time and save patients and the NHS time and money.
There are a number of factors that might affect the likelihood of fracture instability and need for surgery. These include patient factors such as age, functional status and presence of osteoporosis (thin weak bones) and the specific position of the fracture. In this study we will be measuring the fracture positions on x-rays of patients with a Colles' fracture to see if we can accurately predict ED MUA failure on the initial x-ray.
Detailed description
Many thousands of patients attend emergency departments (ED) with displaced (deformed) wrist fractures and undergo closed manipulation under local anaesthetic (MUA) in the ED. Local audit suggests between 25-40% of these manipulated fractures slip back into an unacceptable position (unstable fractures) and require a subsequent open operation to reduce and pin or plate the bone (ORIF). There is some evidence that the degree of initial deformity and other factors might predict instability but this is neither well established nor well researched. Reliably predicting which fractures are likely to fail and which are likely to succeed closed ED manipulation could reduce the proportion undergoing a futile ED procedure, save patients' time and visits to hospital and ensure definitive care the first time round.
We will identify cases from a previously conducted clinical activity analysis of patients who had undergone MUA for Colles' fracture over a two year period at Royal Devon and Exeter Hospital ED. These cases were retrospectively identified (from electronic attendance logs) and followed up until fracture healing or surgery. In this database, the need for subsequent surgery was recorded from electronic records and review of comments in fracture clinic. X-rays of these patients have been identified and anonymised by a member of radiology staff, who is not a member of the research team. These X-rays and the database cases have been given a unique trial number and all identifiable data removed before trial use. The database will be used to provide outcome data for the development of a model to see if x-ray features can reliably predict ED MUA failure. We will exclude Smiths' (anteriorly displaced) fractures and those whom there is no follow up data in the database eg. Patients who were followed up elsewhere.
Anonymised x-rays will be used to develop computer-assisted methods to measure key fracture angles as well as other factors such as degree and position of comminution (fragmentation) and markers of osteoporosis. All x-rays will then by analysed using the system to record these measurements. Depending upon the speed of development, any user facing systems could also be tested on staff to gauge usability and test for inter-rater agreement.
Multivariate analysis of these x-ray features measured by computer, together with the database demographic and outcome data will be used to develop the best model /decision rule to predict likelihood of MUA success. A 'leave one out cross validation' technique will be used to validate such a model and assess whether we could have reduced the ED MUA failure rate without increasing the overall number of open operative procedures. This work will be used to inform a larger prospective study where any decision rules can be assessed and further factors explored with the prospect of adding these to any final computer model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases identified from a previously conducted clinical activity analysis of patients who had undergone MUA for Colles' fracture over a two year period at Royal Devon and Exeter Hospital ED. These cases were retrospectively identified (from electronic attendance logs) and followed up until fracture healing or surgery. In this database, the need for subsequent surgery was recorded from electronic records and review of comments in fracture clinic. X-rays of these patients have been identified and anonymised by a member of staff, who is not a member of the research team. These X-rays and the database cases have been given a unique trial number and all identifiable data removed before trial use.
Key inclusion criteria (1 listed)
- All Adult patients who have under gone a planned ED MUA for a distal radial fracture over a two year period (anonymous data from a previously conducted service evaluation)
Key exclusion criteria (4 listed)
- Smiths' (volarly displaced) fractures
- Those for whom there is no follow up data in the database eg. Patients who were followed up elsewhere.
- Open (compound) fractures (need open surgery to wash out and treat)
- Fractures requiring emergency manipulation due to threatened skin or neurovascular compromise.
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 |
|---|---|---|
| Analysis of primary radiograph and available demographicsMultivariate analysis of the fracture x-ray features measured by computer, together with the database demographic and outcome data will be used to develop the best model /decision rule to predict likelihood of MUA success | Diagnostic test | – |
Primary outcome
Subsequent surgery
Time frame: 6 weeks
Subsequent open surgery performed due to unsatisfactory fracture position following ED fracture manipulation
1 secondary outcome
Unsatisfactory position and recommended surgery
Time frame: 6 weeks
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 1 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Andrew Appelboam principal investigator
Royal Devon and Exeter NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colles' Fracture and Colles' Fracture of Unspecified Radius, Sequela, run by Royal Devon and Exeter NHS Foundation Trust 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 4 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 1 Mar 2019. 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?
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?
Subsequent surgery (time frame: 6 weeks). 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 1 Mar 2019.