Sonographic Assessment of Reduction in Colles' Fracture (SONAR)

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.

Study Overview

• Status: Unknown
• Conditions: Colles' Fracture
• Intervention / Treatment: Radiation: Bedside x-ray; Procedure: Ultrasound imaging

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Richards; Phone Number: +44 1642 342589; Email: s.richards@tees.ac.uk
• Study Contact Backup: Name: Michael Stewart; Phone Number: +44 7812 203011; Email: michael.stewart@lthtr.nhs.uk

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 9HT
      • Recruiting
      • Royal Preston Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Assessment of adequacy of reduction by bedside x-ray during period of intravenous regional anaesthesia (Biers block)	Radiation: Bedside x-ray; Portable x-ray of fracture post-reduction
Experimental: Ultrasound; Assessment of adequacy of reduction by bedside ultrasound performed by the treating clinician during period of intravenous regional anaesthesia (Biers block)	Procedure: Ultrasound imaging; Point of care ultrasound of fracture site during and post-reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Does the use of ultrasound reduce the need for surgical reduction?	Need for surgical reduction/fixation	Four weeks from visit
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
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
Does the use of ultrasound increase the patient satisfaction?	Patient reported satisfaction with reduction of fracture	Four weeks after visit

Collaborators and Investigators

• Sponsor: Simon Richards
• Collaborators: Lancashire Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Simon Richards, Teesside University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: January 25, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 2, 2015
• Last Update Submitted That Met QC Criteria: January 28, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: ultrasonography; Colles' Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Fracture Dislocation; Radius Fractures; Fractures, Bone; Colles' Fracture
• Other Study ID Numbers: 141/13