CompletedNot Applicable

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

United Kingdom48 participantsStarted 2019-10-07

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participant recruitment rate

Timeframe: 6 months

Trial details

NCT IDNCT03868696

SponsorRoyal Devon and Exeter NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-06

View on ClinicalTrials.gov More Radius Distal Fracture trials