Trial on Treatment for Broken Ankles Recruiting Forth Valley Patients
Forth Valley patients who have broken an ankle are being invited to take part in a new national trial to determine whether using a special plaster cast is as good as having surgery for this kind of break. Open to adults between the ages of l6 and 60, several people have already signed up to the Fractured Ankles Management Evaluation (FAME) trial which aims to find out if a special type of plaster cast provides the same outcomes and avoids the need for surgical treatment involving plates and screws.
The study is being overseen by the Oxford Clinical Trials Research Unit within Oxford University and involves around 30 hospitals across the UK including Forth Valley Royal Hospital. Patients who agree to take part will be put into one of the two treatment groups by a computer programme to make sure that the groups are similar and the comparison is fair. After the operation or the plaster cast treatment, all patients in the study will have the usual additional treatment and follow-up that is currently standard practice.
The researchers will ask them about their health and abilities and return to work and usual activities, as well as any complications and specific costs. The answers will be collected at the outset, and at 8 weeks, 4 months and 1 year after the injury, and the results from the two groups will be compared. A few questions will be asked each year for four more years to find out about any longer term effects
NHS Forth Valley Consultant Trauma and Orthopaedic Surgeon, Mr Terence Savaridas, who is leading the study in NHS Forth Valley explained: “In most hospitals, simple ankle breaks are treated with a plaster cast or a walking boot. If the break is more complicated with broken bones out of place or, if they won’t stay in line when walking in a boot or plaster, an operation is performed to fix the bones in place with mental screws and plates.
“We can assess the effects of treatment based on functional outcomes (how well patients are and what they can do after a certain recovery time) as well as the costs of the different treatments. The FAME trial will help us to identify if younger patients can benefit from this special plaster cast treatment and, if outcomes are similar, it will avoid the potential risks and complications involved with surgical fixation which requires the use of metal plates and screws.”
The recently completed AIM trial recently looked at treatments for these more complex breaks in people over 60 years old. It compared the results of the standard treatment, involving the use of plates and screws against the use of a special plaster cast, avoiding a skin incision. By the end of the study there was no real difference in the ankle function and quality-of-life experienced by patients within the two groups. This suggests that using the special plaster cast was just as good as surgery for treating a proportion of ankle fractures in older people.
For further information visit www.fame-study.digitrial.com