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

Colles' Fracture Clinical Trial

— UDiReCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868696
• Other study ID #: 251149
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: July 6, 2020

Study information

• Verified date: March 2020
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 6, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone
• Radius Distal Fracture
• Radius Fractures

Intervention

Procedure:
• MUA with sham ultrasound
Standard MUA with sham ultrasound
• MUA with active ultrasound
Standard MUA guided by ultrasound

Locations

Country	Name	City	State
United Kingdom	Emergency Department	Exeter	Devon
United Kingdom	Barking, Havering and Redbridge University Hospitals Nhs Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	Royal College of Emergency Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emergency Department (ED) manipulation under anaesthesia (MUA) failure rate	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.	6 months
Primary	Participant recruitment rate	Number of participants recruited over the duration of the study	6 months
Secondary	Data completeness.	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	6 months