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Study closed to Recruitment 13Jul2020

WHAT IS THE FORCE STUDY?

The FOrearm Fracture Recovery in Children Evaluation Study. It is a multi-centre prospective randomised equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilisation for acute torus fractures of the distal radius in children. We plan on recruiting a minimum of 696 participants.

The aim of this trial is to evaluate the clinical and cost-effectiveness of soft bandage immobilisation and immediate discharge, compared to rigid splint immobilisation.

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Trial Information

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Oxford Trauma Logo
Oxford Trauma Logo

What is FORCE?

FORCE is a study seeking to improve the treatment of children who have a minor injury to their wrist, called a torus (or buckle) fracture. These injuries are really common, and thousands of children sustain them in the UK each year. They are stable injuries, meaning that the bones do not move out of place, and are really similar to a sprain. It is known that they heal quickly in a few weeks, whatever the treatment given. Despite these high numbers, doctors are not sure whether it is best to treat these injuries with early movement to prevent stiffness or with a hard splint which holds the wrist in one position.

Treatment

This study will compare two treatments:
  • early use of the wrist and an optional bandage, and a point of contact for any ongoing concern.
  • hard splints and follow up according to the treating hospital’s current outpatient policy.

The treatment your child will receive, if you decide to take part, will be chosen by a computer at random. At the end of the study, we hope we will find out which treatment pathway is the most effective in terms of recovery.

Important things you need to know

  • Your child has been diagnosed with a minor injury to their wrist. This is a stable injury like a sprain, and should heal quickly in a few weeks.
  • Doctors are not sure if it is best to allow your child use of the wrist to prevent stiffness and allow faster rehabilitation, or if the wrist should be held in the same position with a hard splint for 3 weeks.
  • This is a randomised study, which means that the treatment offered to your child will be chosen by a computer at random.
  • Your child will be asked to complete some questions about pain, activities and feelings. These questions will be asked when you decide to take part, and on five further occasions up to six weeks from now.
  • Questions after today will be sent to your mobile phone or e-mail. We are able to send you a £10 gift voucher at the end of the study to reimburse you for the costs of your internet data.

Study Sponsor

This study is sponsored by The University of Oxford
ISRCTN ref 13955395

Study Funder

This study has been funded by the National Institute for Health Research's Health Technology Assessment (HTA) Programme (ref: 17/23/02).

Your data

We will be using information from you, your child and their medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your and your child’s information and using it properly

It's important that you know how we are using your personal data and your rights under law. For more information please visit the link : https://www.hra.nhs.uk/information-about-patients/

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Recruitment

Closed to Recruitment 13Jul2020

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Withdrawal from the trial

  • You can withdraw from the trial whenever you like
  • Information collected up until the time of withdrawal will be retained by the research team and included in the final analysis. All of your contact details held by the research team will be destroyed.
  • To withdraw from the trial (and stop receiving E-Mail/Text messages), please contact the trial team, using the contact details below. Please note it may take 24-48 hours for reminders to be stopped

Change how we contact you

If you have any queries or need to change how we contact you, please email or call us via the contact details below

Contact The Trial Team

If you have any queries or need to change how we contact you, please email or call us via the contact details below
Where to Find Us

Oxford Trauma,
Kadoorie Centre
NDORMS,
University of Oxford
John Radcliffe Hospital
Headley Way
Oxford, OX3 9DU

 Email Us At  

force@ndorms.ox.ac.uk

 Email the Chief Investigator  

daniel.perry@ndorms.ox.ac.uk

 Call Us At  

01865 228929