Sonographic Assessment of Reduction in Colles' Fracture

Colles' Fracture Clinical Trial

— SONAR  

Official title:

Sonographic Assessment of Reduction in Colles' Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02353065
• Other study ID #: 141/13
• Status: Recruiting
• Phase: N/A
• First received: January 25, 2015
• Last updated: January 28, 2015
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2015
• Source: Teesside University
• Contact: Simon Richards
• Phone: +44 1642 342589
• Email: s.richards[@]tees.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

Colles fractures are a common type of wrist fracture that often requires manipulation in the Emergency Department. Currently xrays are used to assess whether this has been successful, which are done once the plaster cast has been applied. This study will assess whether ultrasound can be used immediately after the manipulation to check the position, before the plaster cast is applied. This would then be followed by an xray as normal.

The aim is to assess the feasibility of a full study to determine which method is faster, causes less pain, and also to assess if either approach reduces the need for repeat attempts at manipulation and surgical repair.

Description:

Fractures of the distal radius are a frequent cause for presentation to United Kingdom (UK) Emergency Departments, and the Colles' fracture is the most commonly encountered type. These injuries frequently occur in isolation, or associated with only minor injuries, and reduction of displaced fractures is typically performed by Emergency Physicians at the time of first attendance to the hospital.

The usually sequence of events is clinical examination, x-ray imaging to confirm the fracture, then the reduction is performed with appropriate analgesia or anaesthesia, the arm placed in a plaster backslab, and repeat imaging is taken to confirm adequacy of reduction. If the reduction is not satisfactory, repeat manipulation is required.

Haematoma block and Biers block permit x-ray imaging of the manipulated wrist while the anaesthetic action is still effective, permitting re-manipulation without further administration of local anaesthetic. Sedation is usually kept to as short a time as possible, and is not usually maintained while imaging is performed. There is usually some degree of delay while x-rays are taken and made available for viewing, and this wait prolongs the procedure for the patient and the treating clinician. In addition, Biers block cannot be tolerated for long by most patients, so any delay makes it less likely that a re-manipulation can be achieved within the time the patient can tolerate. If a patient has been sedated, a re-manipulation will require a further sedative (or alternative) procedure with the concomitant risks that entails.

Ideally, imaging would be performed rapidly, immediately at the end of the manipulation, prior to application of plaster, allowing confirmation of the reduction or immediate re-manipulation if necessary. This description of imaging provided at the point of care by the treating clinician, aimed at answering a clearly defined question ('is this an adequate reduction?') matches the description of focussed emergency ultrasound in other applications. If ultrasound could be used to assess fracture reduction, it would have potential to save clinician time, patient time and discomfort, and reduced the need for repeated manipulations and surgical repair.

This study intends to assess the feasibility of a full trial of efficacy comparing ultrasound with x-ray to guide the reduction of these fractures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Adults with isolated fractures of the distal radius undergoing manipulation in the Emergency Department with Intravenous Regional Anaesthesia (Biers Block)

Exclusion Criteria:

• Age under 16

• Contraindication to Biers block

• Unable to give informed consent

• Multiple injuries

• Open fracture

• Prisoners

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colles' Fracture
• Fractures, Bone

Intervention

Procedure:
• Ultrasound imaging
Point of care ultrasound of fracture site during and post-reduction

Radiation:
• Bedside x-ray
Portable x-ray of fracture post-reduction

Locations

Country	Name	City	State
United Kingdom	Royal Preston Hospital	Preston	Lancashire

Sponsors (2)

Lead Sponsor	Collaborator
Simon Richards	Lancashire Care NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total inflation time of the tourniquet used during the Biers Block	The total inflation time of tourniquet used for Biers block	The duration the tourniquet is inflated; complete within 30 minutes of the procedure commencing	No
Secondary	The total number of manipulations required per patient within the Emergency Department	Number of attempts at manipulation within Emergency Department	The duration of the manipulation procedure; complete within 30 minutes of procedure commencing	No
Secondary	Does the use of ultrasound reduce the need for surgical reduction?	Need for surgical reduction/fixation	Four weeks from visit	Yes
Secondary	Does the use of ultrasound reduce the time spent within the Emergency Department?	Total time spent within Emergency Department	End of initial ED visit, within twelve hours of initial arrival to the hospital	No
Secondary	Does the use of ultrasound reduce the pain score during the reduction?	Patient reported pain score at the end of the fracture reduction	End of procedure - within 30 minutes of the procedure commencing	No
Secondary	Does the use of ultrasound increase the patient satisfaction?	Patient reported satisfaction with reduction of fracture	Four weeks after visit	No