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Completed

NCT Number: NCT03868696

Ultrasound Directed Reduction of Colles Type Distal Radial Fractures in ED (UDiReCT)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department, Exeter, Devon, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with Colles' type fractures of the distal radius undergoing fracture manipulation in the ED
  • UDiReCT Trial trained staff available

Exclusion criteria

  • 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

Treatment and study plan

MUA with sham ultrasound

Procedure

Standard MUA with sham ultrasound

MUA with active ultrasound

Procedure

Standard MUA guided by ultrasound

Primary outcomes

  1. Participant recruitment rate

    Time frame: 6 months

    Number of participants recruited over the duration of the study

Secondary outcomes

  1. Data completeness.

    Time frame: 6 months

    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

Other outcomes

  1. Emergency Department (ED) manipulation under anaesthesia (MUA) failure rate

    Time frame: 6 months

    The proportion (%) of cases having undergone surgical fixation of the index fracture after ED MUA, within 6 weeks of injury . This is the proposed outcome for a definitive trial.

Sponsors and collaborators

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust

Other

Collaborators

  • Royal College of Emergency Medicine

Registry information

Acronym: UDiReCT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2019
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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