This study will investigate whether a non-surgical treatment option will provide patients with comparable ankle function and quality of life to those treated with surgery.
Both treatments are used across the NHS currently and are not new or experimental.
In this study we use a process called randomisation, which means you cannot choose which treatment you have.
If you decide you would like to be involved in the study you will be asked to sign a consent form.
The only additional commitment we would ask of you would be to fill out a questionnaire at the start of treatment and on three occasions during your recovery.
As you have broken your ankle you are eligible to be a part of this study.
This study is expected to last 8 years. At the end of the study we will publish the findings in medical journals and at medical conferences.
You will be followed up according to the usual schedule at your hospital, in the same way as patients who are not in this study.
After you leave the hospital, your hospital doctor will arrange to see you at regular intervals for routine check-ups. We will follow how your recovery progresses over the next 12 months. The research team will obtain relevant information from your hospital records to see how you are getting on. This will include information about how long you spent in hospital, what treatments you required and how well you recovered. We will also use records from routinely collected databases to get information about any existing medical problems you have, any further treatments you have needed for your ankle or other medical conditions and any complications you have suffered. We can take this information into account when analysing the results of the study and to look at the cost to the NHS.
We will ask you to fill out a questionnaire at 8 weeks, 4 months and 12 months after your injury.
The questions will be very similar to those asked at the start of the study. We will send you a weblink to the questionnaire electronically by email or text message. At 12 months we will also be interested to hear about your experience of being in the study and will ask you some questions about this.
We will also send you short questionnaires about how well your ankle is working every year for four more years. Finally, we will get routine NHS information collected about you over the next five years to see what the long-term outcomes are following your injury.
If you have no smartphone or access to a computer, we will phone you to ask the questions on the questionnaires. We may also phone you if we need to clarify any of your responses. We will send a welcome letter with a small gift such as a fridge magnet, which is yours to keep, and later in the study we may send you other similar small gifts, postcards and questionnaires by post. For these purposes, we are collecting your postal address.
We will send a welcome letter with a small gift such as a fridge magnet, and later in the study we may send you other similar small gifts, postcards and questionnaires by post. For these purposes, we are collecting your postal address. The gifts are yours to keep whether you answer the questions or not.
What will happen if I take part?
What will happen to the results?