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Forearm Fracture Recovery in Children Evaluation: A multi-centre prospective randomised equivalence trial of a soft bandage and immediate discharge versus current treatment with rigid immobilisation for torus fractures of the distal radius in children.

BACKGROUND


Torus (buckle) fractures of the wrist are the most common fractures in children. They result from injury to growing bones and account for 500,000 UK emergency attendances annually. Torus fractures have a very low risk of complications and universally heal well.

There is considerable variation in the management of torus fractures. Treatment varies from the use of a removable rigid splint, to plaster cast immobilisation, to more flexible splints or soft bandages.
The key differences relating to the degree of immobilisation provided, and the follow-up required. Non-removable rigid casts are no longer recommended for the treatment of these injuries. Removable splints immobilise the wrist and may provide the best pain relief. Soft bandaging restricts movement the least and may encourage early function, but concern remains about pain and the potential for complications, despite evidence to the contrary. The National Institute for Health and Care Excellence (NICE) guidelines made recommendations on the management of these injuries and concluded that bandaging was probably the best treatment approach, due the convenience, adequate pain control and the ability to promote early function, though asked whether any treatment is really necessary. NICE also recommended that no follow-up of these injuries is necessary because they are almost always complication free and they universally heal well. However, there is variable follow-up at different hospitals.

The aim of this trial is to assess effectiveness of the optional use of soft bandage and immediate discharge, compared to rigid splint immobilisation.

STUDY DESIGN


The trial will be recruiting from a minimum of 10 centres treating children's fractures across the UK. All children presenting at the trial centres with an acute torus fracture of the distal radius are potentially eligible to take part in the trial. We plan on recruiting a minimum of 696 patients, a minimum of 348 in the 4-7 year age group and a minimum of 348 in the 8-16 age group.
A randomisation sequence, stratified by centre and age group (4-7 years and ≥8 years) will be administered online. Each patient will be randomly allocated (1:1) to either a soft bandage and immediate discharge, or rigid splint immobilisation (as per current practice at the treating centre) and follow-up as per current practice at the treating centre.
Pain-intensity using the Wong-Baker FACES Pain Scale, Patient Report Outcomes Measurement System (PROMIS) Upper Extremity Score for Children, health-related quality of life and Health Economic follow-up data will be collected via a smart phone/email link to an electronic questionnaire up to the 6 week time point.
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. The primary outcome measure for this study is the Wong-Baker FACES Pain Rating Scale at 3 days.

 

The trial is due to open to recruitment in November 2018, recruitment end December 2019 and Follow-up completed by February 2020. 

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