Condition category
Musculoskeletal Diseases
Date applied
13/11/2020
Date assigned
20/11/2020
Last edited
20/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
It is common for children to sustain fractures (breaks) to their bones, and current estimates are that 1 in 3 children will sustain a break during childhood. Despite the common nature of these injuries, there are few research studies to guide the best way to treat them. One of the most common injuries in children is a broken ankle, and the majority of these do not need an operation. There are a range of different ways to treat these so-called 'stable' injuries including the use of a supportive bandage (tubigrip), brace, or plaster cast. Each has its own advantages and disadvantages and a recent survey suggested that there is a range of different treatments offered to the same injury in different hospitals.

Who can participate?
The study is looking for children aged 5-15 who break a bone in their ankle.

What does the study involve?
X-rays will be reviewed by the doctors who will decide if the child is eligible for the trial. The study will involve being allocated to one of three common treatments for this injury - a removable bandage, a removable splint or a walking cast. The child will be prescribed this for 2 weeks and will be allowed to walk using crutches. Follow up will be through online questionnaires sent to families to track progress and with a 2-week patient diary that needs to be returned to the study team.

What are the possible benefits and risks of participating?
The researchers cannot promise the study will help the participants but the information from this study may help children with similar injuries recover with the best possible outcomes. There are no anticipated disadvantages in participating in this study. All of the treatments are safe and commonly used to treat this fracture in the UK. Previous studies have suggested that the risk of pressure injuries (skin irritation or blisters) may be slightly higher with the boot. This risk will be reduced by providing a padded sock to wear with this device. It is possible to develop a heat-related injury with the cast which is why only trained staff will apply and remove this device.

Where is the study run from?
Nottingham University Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
November 2020 to June 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Jessica Nightingale
jessica.nightingale@nuh.nhs.uk

Trial website

https://www.nottinghamorthopaedics.co.uk

Contact information

Type

Scientific

Primary contact

Miss Jess Nightingale

ORCID ID

Contact details

Research Manager
Trauma and Orthopaedics
Nottingham University Hospitals
T&O Audit Office
C-West (1285)
QMC
Nottingham
NG7 2UH
United Kingdom
+44 (0)7810326600
jessica.nightingale@nuh.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 46531, IRAS 277534

Study information

Scientific title

Management of ANkle fractures in CHildren: the feasibility Of a Randomised controlled trial (ANCHOR)

Acronym

ANCHOR

Study hypothesis

Is it feasible to conduct a randomised controlled trial to compare cast, removable splint and supportive bandage for low-risk ankle fractures in children?

Ethics approval

Approved 12/10/2020, East Midlands - Derby Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8285; derby.rec@hra.nhs.uk), ref: 20/EM/0189.

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Injuries to the knee and lower leg

Intervention

A feasibility multi-centre parallel group trial with 1:1:1 allocation of patients to removable splint treatment with a brace or bandage or below knee cast. The trial will collect outcome data at 6 and 12 weeks with nested qualitative interviews to inform future trial design.

Children presenting with an acute ankle injury will be assessed in the Emergency Department and a provisional diagnosis identified. Emergency department treatment will be at the discretion of the treating clinician. Children are reviewed at a specialist fracture clinic within 72 of presentation in line with the British Orthopaedic Association’s BOAST 7 recommendations. Children who are managed in virtual fracture clinics or in emergency department fracture clinics may be recruited directly from the emergency department.

The parents will decide if their child is eligible to take part in the trial in conjunction with their surgeon and child and will be referred to the research team. Screening logs will be maintained throughout the trial to assess the main reasons for patient exclusion as well as number of patients unwilling to take part. For parents and children in whom English is not their first language trial materials will be available translated on request. However, patients will only be invited to participate if they are able to complete the outcome measures in English, as there are no validated translations of the candidate measures.

The primary outcomes will be collected using a electronic form at recruitment, at 2 and 6 week follow up and at 12 weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Feasibility outcome measures:
1. Recruitment rates compared to site screening logs as the number of eligible participants who are randomized in the study
2. Retention rates, drop out and crossovers as a proportion of recruited patients who complete the study regime
3. Adherence to treatments measured using a patient diary for 14 days of treatment
4. Trial experience and qualitative feedback from participants collected through structured interviews with a sample of participants at 12-24 weeks

Secondary outcome measures

1. Physical function measured by ASK-P, PROMIS Mobility at 6 and 12 weeks
2. Quality of life measured by EQ-5D-Y and PedsQL4.0 at 6 and 12 weeks
3. Global rating of change score at 6 and 12 weeks
4. Daily pain scores measured using a patient diary for 14 days of treatment
5. Re-injury rates measured using a self-reported questionnaire at 6 and 12 weeks
6. Complications measured using a self-reported questionnaire at 6 and 12 weeks

Overall trial start date

01/11/2020

Overall trial end date

10/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 5-15 years inclusive
2. Proven low-risk ankle fracture on x-ray: minimally displaced or undisplaced fibular fracture
3. A clinical undisplaced fracture which fulfils the Ottawa criteria:
3.1. A history of trauma
3.2. Tenderness at the posterior edge of the lateral malleolus
3.3. Unable to weight bear for more than 4 steps
3.4. No alternative cause of pain identified on x-ray

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 156; UK Sample Size: 156

Participant exclusion criteria

1. Additional injuries
2. Injury is more than 7 days old at recruitment
3. Current medical condition that prevents the use of any of the treatments (e.g. dermatitis, vasculitis, congenital foot or ankle deformities)
4. In conjunction with their parents are unable to complete the outcome measures chosen in English

Recruitment start date

10/12/2020

Recruitment end date

10/12/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospital
Nottingham University Hospitals NHS Trust Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Leicester Royal Infirmary
University Hospitals of Leicester NHS Trust Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Alder Hey Children’s Hosptial
Alder Hey Children's NHS Foundation Trust Eaton Road
Liverpool
L12 2AP
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust

Sponsor details

Trust Headquarters
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 970 9049
Researchsponsor@nuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nuh.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: NIHR200580

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study results will be presented at national and international meetings and disseminated via peer reviewed journals. Participants will be provided with a plain English summary of results and a statement will be placed on the group’s website.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

10/06/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/11/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR) (UK)