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

NCT03859999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 279

Last updated 2019-03-01

No results posted yet for this study

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.

Conditions

  • Colles' Fracture
  • Colles' Fracture of Unspecified Radius, Sequela

Interventions

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

Sponsors & Collaborators

  • University of Exeter

    collaborator OTHER

  • City, University of London

    collaborator OTHER

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Andrew Appelboam · Royal Devon and Exeter NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-02-01
Completion
2018-05-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03859999 on ClinicalTrials.gov