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PRediction of Outcome With ED Intervention for Colles Type Wrist Fractures [PREDICT] (PREDICT)

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ClinicalTrials.gov Identifier: NCT03859999
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
University of Exeter
City, University of London
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

Brief 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.

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.


Condition or disease Intervention/treatment
Colles' Fracture Colles' Fracture of Unspecified Radius, Sequela Diagnostic Test: Analysis of primary radiograph and available demographics

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.

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Study Type : Observational
Actual Enrollment : 279 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prediction of Failure of Emergency Department Closed Manipulation of Colles' Distal Radial Fractures
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures


Intervention Details:
  • Diagnostic Test: Analysis of primary radiograph and available demographics
    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


Primary Outcome Measures :
  1. Subsequent surgery [ Time Frame: 6 weeks ]
    Subsequent open surgery performed due to unsatisfactory fracture position following ED fracture manipulation


Secondary Outcome Measures :
  1. Unsatisfactory position and recommended surgery [ Time Frame: 6 weeks ]
    The subsequent occurrence of an unsatisfactory fracture position after ED manipulation as determined by the treating orthopaedic surgeon such that surgery is recommended



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859999


Locations
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United Kingdom
Emergency Department
Exeter, Devon, United Kingdom, EX2 5DW
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
University of Exeter
City, University of London
Investigators
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Principal Investigator: Andrew Appelboam Royal Devon & Exeter Hospital
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Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03859999    
Other Study ID Numbers: 1802595
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Colles' Fracture
Distal radial fracture
Manipulation under anaesthesia (MUA)
Emergency Department
Additional relevant MeSH terms:
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Colles' Fracture
Fractures, Bone
Wounds and Injuries
Fracture Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Radius Fractures