ANCHOR: Ankle fractures in children

• Research type

  Research Study

• Full title

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

• IRAS ID

  277534

• Contact name

  Jennifer Boston

• Contact email

  R&I@nuh.nhs.uk

• Sponsor organisation

  Nottingham University NHS Trust

• ISRCTN Number

  ISRCTN29688616

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  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.

  We plan to undertake a trial to compare the outcomes of different treatments (supportive bandage, split or plaster) in children presenting with low risk 'stable' fractures of their ankle. Patients will be recruited in the fracture clinic following diagnosis of their injury to the ANCHOR TRIAL – a small-scale study to assess the feasibility of conducting a larger trial. We will recruit 124 children for face-to-face review at 2 and 6 weeks and remote follow up at 12 weeks.

  A series of structured interviews will be completed with 24 parent-child dyads to explore the experience of participating in this study.

  Summary of results
  Why we did this study

  Ankle fractures are common in children. Many of these injuries are “low-risk” fractures, meaning the bones are stable and are very unlikely to move out of place. Even so, there is no clear agreement on the best way to treat them. Some hospitals use a walking cast, others use a removable boot or splint, and some use only a supportive elastic bandage. We carried out this study to check whether it is practical to run a larger, definitive randomised trial to find out which approach is best for children and families.

  What we did

  We recruited children aged 5 to 15 years with a low-risk ankle fracture from six UK hospitals. With the family’s agreement, children were randomly allocated to one of three treatments for two weeks:
  1. a supportive elastic bandage,
  2. a removable splint/brace (such as a boot), or
  3. a below-knee walking cast.
  We then followed children up at 2, 6, and 12 weeks after injury. We recorded any problems or complications, whether children needed a change in treatment, and how well children recovered using short questionnaires about mobility, quality of life, and return to normal activities.

  What we found

  • Recruitment was achievable: 87 children took part across six hospitals, with an average recruitment rate of about 0.9 participants per site per month.
  • Treatment was generally acceptable: Nearly all children stayed in their allocated treatment. Two children in the supportive bandage group switched to another device because the bandage was not tolerated or families re-attended for reassessment.
  • Complications were uncommon and similar across groups: Six children (6.9%) had a complication over 12 weeks. These included one child with skin blisters in a cast, two children who re-injured the ankle during follow-up (one in the cast group and one in the bandage group), and a small number who needed a longer period of support because pain persisted after the initial two weeks.
  • Most children recovered well: By 12 weeks, all children had returned to school.
  • Questionnaire return was a challenge: Just over half of families returned follow-up questionnaires at six weeks (51.2%). Text message reminders and shorter questionnaires helped a little, but completion rates were still lower than ideal for a full-scale trial.
  • No clear “best” treatment emerged in this small feasibility study: Differences between groups were small and the study was not designed or powered to prove one treatment was better than another.

  What this means

  This study shows it is possible to run a larger randomised trial comparing treatments for low-risk ankle fractures in children. There is still genuine uncertainty about which option is best, and all three approaches appeared safe and well tolerated with similar complication rates.

  However, because many children recover quickly, families who are doing well may be less likely to return questionnaires. For a larger trial, an outcome based on complications or “treatment failure” (for example, needing extra immobilisation, skin problems, re-attendance for worsening symptoms, or re-injury) may be more reliable for follow-up, with questionnaires included as important secondary outcomes. A larger trial should also include an economic evaluation, as simpler treatments may reduce the need for clinic visits, casting materials, and time off school or work.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  20/EM/0189

• Date of REC Opinion

  13 Oct 2020

• REC opinion

  Further Information Favourable Opinion